The Next Generation in Orthobiologics

THE NEXTGENERATION IN ORTHOBIOLOGICS THE ARTHREX DIFFERENCE Since 1984, Arthrex has been a privately held corporation committed to one thing: providing the finest quality products and educational services to meet the special needs of surgeons and their patients. Arthrex is dedicated to creative product development and medical education with an experienced, devoted team of professionals who are truly committed to continuing this long-term tradition. New product innovation is the heart and soul of Arthrex and has resulted in the development of more than 1000 products per year for arthroscopic and minimally invasive orthopedic surgical procedures. Our goal is to make technically demanding surgical procedures easier, safer and reproducible. Your trust in Arthrex products means you are backed by a company committed to uncompromising quality and constant product innovation, while providing you with the most competent technical customer support in the industry. AUTOLOGOUS BLOOD TABLE OF CONTENTS Arthrex ACP® Double-Syringe System 1 Arthrex Angel® cPRP System for PRP Formulations 2 Arthrex Angel® cPRP & Bone Marrow Processing System 3 Bone Marrow Aspiration 4 Viscous Delivery Systems 5 IntraOsseous BioPlasty™ System 6 BONE GRAFTING ArthroCell™ Cellular Bone Graft 7 AlloSync™ Pure Demineralized Bone Matrix 8 AlloSync™ Demineralized Bone Matrix and BioXpress™ Graft Delivery Device 9 AlloSync™ Demineralized Cancellous Sponges and Cortical Fibers 10 StimuBlast® Demineralized Bone Matrix 11 Revision Bone Dowels 12 Quickset™ Calcium Phosphate Cement 13 Allograft Wedges 14 OSferion – Wedge and Trapezoid 14 CARTILAGE AND MENISCUS BioCartilage® Extracellular Matrix 15 Cartiform® Viable Osteochondral Allograft 16 Autograft OATS® Set 17 Small Joint OATS® Set 17 OATS® AlloPlug and AlloSync™ Cancellous Plugs 18 Fresh Cartilage 19 Precut Fresh Osteochondral Allograft Cores 19 Allograft OATS® System 20 BioUni® OATS® Instrument Set 21 Talus OATS® Set 22 Meniscus Allografts 22 Meniscal Implantation Techniques 23 SOFT TISSUE Amnion™ Matrix and Viscous 24 ArthroFLEX® Dermal Allograft 25 Arthrex DX Reinforcement Matrix 26 Tendon Allografts – Construct Grafts 27 Tendon Allografts – Standard Grafts 28 WOUND CARE JumpStart® Antimicrobial Wound Dressing 29 ProWick® Postoperative Dressing and Cold Therapy System 30 REFERENCES AND ORDERING INFORMATION 31 AUTOLOGOUS BLOOD Arthrex ACP® Double-Syringe System There has been increased interest in autologous blood products for use in a number of orthopedic therapies. The main effects of platelet-rich plasma are thought to be caused by growth factors released from the platelets, which may play a beneficial role within these therapies. Features and Benefits: • The Arthrex ACP (Autologous Conditioned Plasma) system allows for rapid and efficient concentration of platelets and growth factors from autologous blood for use at the treatment site. • The unique double-syringe design allows for convenient and safe handling, as the whole preparation process takes place in a closed system. • The Arthrex ACP system is affordable, easy to use, and has a quick procedure time when compared to other PRP devices. • White blood cells, specifically neutrophils, are NOT concentrated within the ACP system. These cells can cause a detrimental effect on the healing process due to release of degradative proteins and reactive oxygen species.1,2 ACP/Double Syringe with Cap ABS-10010S Series I ACP Blood Draw Kit ABS-10011 Series II ACP Blood Draw Kit ABS-10012 Centrifuge 1206-01 Double Syringe Bucket 1491 Bucket Cap 1492 Counterbalance ABS-10027 Arthrex Biologics Cart ABS-10100 Cap for Double Syringe Series I ACP Kit Series II ACP Kit Arthrex Biologics Cart can be used for Angel or ACP Centrifuge The Arthrex ACP double-syringe system is used to facilitate the safe and rapid preparation of autologous platelet-rich-plasma (PRP) from a small sample of blood at the patient’s point of care. The PRP can be mixed with autograft and allograft bone prior 1 to application to an orthopedic surgical site as deemed necessary by the clinical use requirements. Arthrex Angel® cPRP System for PRP Formulations AUTOLOGOUS BLOOD What sets the Arthrex Angel cPRP System apart from the competition is technology. Using a proprietary platelet sensor and 1-button automation to prepare customized PRP formulations, the Angel cPRP System can deliver platelet concentrations up to 18x baseline with adjustable leukocyte concentrations. Features and Benefits: • Proprietary platelet sensor system • Adjustable platelet concentrations • Adjustable WBC concentrations • Flexible processing volume 40 mL-180 mL • Each processing kit can process 3 cycles up to 180 mL on the same patient • Programmable and capable of storing up to 30 custom processing protocols • Closed system, delivers PRP, PPP and RBCs into separate, sterile compartments Arthrex Angel System ABS-10060 Arthrex Angel System, Refurbished ABS-10060R Arthrex Angel Kit ABS-10063 Arthrex Angel PRP Kit ABS-10061T Arthrex Biologics Cart ABS-10100 ® 2 AUTOLOGOUS BLOOD Arthrex Angel® cPRP & Bone Marrow Processing System Technology is what sets the Arthrex Angel cPRP System apart from the ® competition. The Arthrex Angel cPRP & Bone Marrow Processing System uses proprietary sensor technology and 1-button automation to deliver customized PRP concentrate from bone marrow aspirate (BMA). The Angel system is the only device that can provide PRP concentrate from BMA with adjustable cellular levels. Bone marrow is a rich source of platelets, nucleated cells and progenitor cells. Arthrex Angel System ABS-10060 Arthrex Angel cPRP & Arthrex Angel System, Refurbished ABS-10060R Platelet Nucleated Cell Hematopoetic Cell Total Neutrophil Bone Marrow Concentration (K/mL) Concentration (K/mL) Concentration (K/mL) (x10^6) Arthrex Angel cPRP & BMA Tray ABS-10062T Processing System Arthrex Angel cPRP & Powered BMA 87.7 ± 6.4 24.5 ± 15.6 0.002 ± 0.001 612.1 BMA Kit ABS-10062D Arrow® OnControl®* System PRP Concentrate 787.0 ± 317.6 240.5 ± 186.6 0.081 ± 0.056 132.9 Sterile Procedure Tray 9403-VC-006 from BMA Arrow OnControl Power Driver ® ® Increase Above Baseline ˜9x ˜10x ˜33x 80% with Cradle 9401 Arthrex Biologics Cart ABS-10100 >80% recovery of the hematopoietic cell lines with an 80% reduction in the undesirable neutrophil cell content. Arthrex Angel cPRP & BMA Tray Arthrex Angel cPRP & Powered BMA Kit Arrow ® OnControl ® System Sterile Procedure Tray * Arthrex Angel cPRP & Bone Marrow Processing System Key Features: • Proprietary platelet sensor system In vitro culture expansion • Adjustable platelet concentrations of progenitor cells over 96 hours • Adjustable WBC concentrations • Programmable – can store up to 30 custom processing protocols • Flexible processing volume 40 mL-180 mL • Each processing kit can process three cycles up to 180 mL, on the same patient • Closed system, delivers PRP, PPP and RBCs into separate, sterile compartment *Arrow and OnControl are registered trademarks of Teleflex, Inc. 48 hrs. 96 hrs. 3 Bone Marrow Aspiration AUTOLOGOUS BLOOD Bone marrow-stimulating techniques, like abrasion and microfracturing, have been advocated for over 20 years.3 Bone marrow is a source of stem cells and progenitor cells that differentiate into a variety of tissues (eg, bone, cartilage, tendon, ligament, fat, muscle, nerve). There has also been discussion that bone marrow stem cells have a role in the maintenance and repair of several other tissues.4 Because of the plasticity exhibited by bone marrow, a number of studies have investigated the benefits of bone marrow used: • Through microfracturing into a collagen matrix for treatment of osteochondral defects4 • With grafts to treat tibial nonunions5,6 • For tendon graft-to-bone interface in rabbit models at early time points7, 8 • For spinal fusion in a rabbit model9 • With growth factors for the treatment of large bony defects in animals10 • With porous ceramic scaffolds implanted in human femoral defects with positive results10 Bone marrow aspirate (BMA) provides a cell suspension that can be readily processed intraoperatively for immediate implantation. BMA is commonly withdrawn from the iliac crest, but can also be aspirated from the femur and humerus. BMA can be injected directly to a repair site, localizing a specific volume of BMA to support and facilitate healing. Bone Aspiration Kit The Bone Aspiration Kit is a convenient, sterile combination of instruments useful for aspirating bone marrow arthroscopically. Bone Aspiration Kit (AR-1101DS) Contents: 1 Bone Marrow Aspiration Needle 1 Syringe, 60 cc 1 Prep Tray 4 AUTOLOGOUS BLOOD Viscous Delivery Systems Key Features: • Quick and simple to attach/detach • Easy to fill – no need to disassemble • 11:1 ratio allowing homologous mixture of 2 fluids • Use to provide a low- or high-viscosity fluid Viscous-Gel™ High Viscosity Ratio Applicator • Extra long, blunt, fenestrated and beveled delivery needles with 10 cm Mixing Tip • ACP/PRP can be mixed with allograft or autograft bone prior to application to an orthopedic surgical site as a spray, gel or clot Viscous-Gel Applicator, High Viscosity ABS-10050 Viscous-Spray Applicator, Low Viscosity ABS-10051 Viscous-Spray II Applicator, Low Viscosity ABS-10052 Fenestrated Delivery Needle ABS-20000 Tuohy Delivery Needle ABS-21000 Cannula Bending Tool AR-6650 Viscous-Spray™ Low Viscosity Ratio Applicator Micromedics with 3 cm Mixing/Spray Tip Ratio Applicator Assembly 11:1 Ratio SA-1001 Applicator with Dual Spray Tips 11:1 Ratio SA-1060 16 ga x 10 cm (4 in) SA-3600 20 ga x 5 cm (2 in) SA-3615 20 ga x 10 cm (4 in) SA-3618 20 ga x 18 cm (7 in) SA-3619 20 ga x 26 cm (10.25 in) SA-3620 Dual Cannula Semiflexible Endoscopic, 32 cm SA-3650 Dual Spray Tip SA-3660 Endoscopic Applicator with Mixing Tip, Viscous-Spray II Low 30 cm, 1:1 Ratio SA-3662 Viscosity Ratio Applicator with Blending Connector with Single Flexible a Clog-resistant Mixing/Spray Tip Cannula SA-3673 Blending Connector with Single Spray SA-3674 Mixing Applicator Low Viscosity with Spray Tip SA-3675 Applicator Procedure Kit, 11:1 Ratio SA-4400 Dual Spray Procedure Kit, 11:1 Ratio SA-4460 Gas Assisted Procedure Kit, 11:1 Ratio SA-6111 Applicator Assembly, 3 cc, 1:1 Ratio SA-3303 10 cc Applicator Assembly, 1:1 Ratio Fenestrated Delivery Needle 17-gauge, 14.63 cm Precontour either delivery from hub, 8 holes along first needle with the Arthrex 1.27 cm of tip (0.3 mm diameter holes) Cannula Bending Tool Gel easily dispersed from tip Tuohy Delivery Needle 17- gauge, 15.07 cm from hub Adipose Tissue Harvesting Kit ABS-10055 5 IntraOsseous BioPlasty™ System AUTOLOGOUS BLOOD Recent discussions around how to treat symptomatic bone marrow lesions (BMLs) have led to the introduction of the IntraOsseous BioPlasty (IOBP™) procedure which centers around the ability to treat insufficiency fractures, persistent bone bruises, BML associated with osteoarthritis and early stages of avascular necrosis. The principles of the IOBP technique are simple: perform a core decompression then deliver a concentrated dose of PRP concentrate from BMA using the Arthrex Angel® cPRP & Bone Marrow Processing System. When mixed with a flowable demineralized bone matrix, such as DBM gel, the biologic material delivered to the bone marrow lesion contains all of the necessary components to aid bone repair, including an osteoconductive and osteoinductive scaffold, as well as an osteogenic source of stem cells. Research has shown the positive clinical outcomes of treating BMLs and persistent bone fracture, or nonunions, with bone marrow concentrate.11 Clinical outcomes from another study indicate pain and function improves following intraosseous delivery of a biologic into BMLs associated with osteoarthritis.12 The IntraOsseous BioPlasty procedure is the biologic treatment of bone marrow lesions with techniques that encourage physiologic bone remodeling and repair. Arthrex Angel cPRP & BMA Tray ABS-10062T IOBP Core Decompression and Delivery Kit, Open Tip ABS-2000-OT Accessories Delivery Cannula, 8G x 4.5”, Closed Tip RAN-811-CT Delivery Cannula, 8G x 6”, Open Tip RAN-815-OT Note: Demineralized bone matrix gel, provided separately, may be mixed with the autologous blood solution. Concentration of Stem Cells in Clinical Outcomes When Bone Graft Affect Outcome11 Treating Osteoarthritis12 Baseline 5000 10 Week 24 Success 4000 Failure 8 3000 6 2000 4 1000 2 0 0 Total MSC/cm3 VAS Lequesne Index 6 BONE GRAFTING ArthroCell™ Cellular Bone Graft Viable Allogenic Cellular Bone Matrix • Product is moldable and contains donor mesenchymal stem cells, osteoprogenitor cells and marrow-isolated adult multilineage inducible (MIAMI) cells supporting osteogenic healing processes • Includes a proprietary blend of mineralized and demineralized bone particulate including cortical shavings, crushed cancellous chips and microparticulate bone Key Features: • A safe/nonimmunogenic cellular bone matrix intended for use as a bone void filler for bone defects, fusions and nonunion orthopedic applications • Osteogenic, osteoconductive and osteoinductive potential • Final product is moldable for ease of use and optimal handling • Novel cryoprotectant (DMSO-Free) and noncytotoxic • Convenient: stored in a cryogenic freezer (-65˚C) up to 2 years ArthroCell Cellular Bone Graft, 2.5 cc ABS-2009-02 ArthroCell Cellular Bone Graft, 5.0 cc ABS-2009-05 Mixing Delivery Syringe, 14 cc ABS-2000 Gel Microparticulate Bone Cell Vial 7 PURE AlloSync™ Pure Demineralized BONE GRAFTING Bone Matrix AlloSync Pure dehydrated osteoinductive demineralized bone matrix is derived from 100% human allograft bone with no extrinsic carriers. AlloSync Pure bone matrix resists irrigation and can be used in a fluid environment (Figure 2). The clinician can control the handling properties of AlloSync Pure bone matrix, which includes decreasing the viscosity for injectable applications or increasing the viscosity to add autograft and/or allograft. The proprietary rice-shape fiber technology used to process AlloSync Pure bone matrix increases the osteoinduction and osteoconductive surface area to accelerate cellular ingrowth. Features and Benefits: • Derived from 100% human allograft bone without any extrinsic carriers • Every lot poststerilization is tested in vivo to ensure osteoinductivity • Demineralization process preserves native bone morphogenetic proteins (BMPs) and growth factors • Resists irrigation • Histologically proven to contain all 5 elements of bone formation including new bone, bone marrow, osteocytes, chondrocytes and cartilage postimplantation at 28 days13 (Figure 1) • May be hydrated with bone marrow concentrate (BMC), platelet-rich plasma (PRP), blood, saline or other cellular components • Sterile to device grade standards (10-6) and stored at ambient temperature • Provided in a ready-to-use mixing jar • 4 sizes available • 5-year shelf life Figure 1: AlloSync Pure demineralized bone matrix histology Figure 2: AlloSync Pure demineralized bone matrix can be used in an arthroscopic environment. 8 BONE GRAFTING AlloSync™ Demineralized Bone Matrix AlloSync Bone Products May Provide Osteoinductive and Osteoconductive Properties: Comparison of Two DBMs • Osteoinduction – signaling molecules such as bone morphogenetic proteins (BMPs) that aid in cell differentiation down osteoblastic pathways • Every lot of demineralized bone matrix (DBM) is tested for osteoinductive potential, using either an in vitro assay or in vivo model • Osteoconduction – scaffolding from DBM particles for osteoblasts to form new bone RPM Carrier Glycerol Carrier • Additional scaffolding properties are provided in AlloSync cancellous bone (CB) with the addition of cancellous bone chips Superior Handling Characteristics via the Reverse Phase Medium (RPM) Carrier: • RPM is an inert, biocompatible co-polymer consisting 5 Minutes Immersion Time of polypropylene oxide and polyethylene oxide • Material is flowable at room temperature and thickens to become more viscous at body temperature • RPM allows the DBM graft to be moldable and packed AlloSync Gel into any defect size or shape • AlloSync bone products will resist irrigation and can AlloSync be used in a fluid environment without the fear Putty of graft migration, unlike some other DBMs AlloSync Bone Products Offer Ease of Use and Terminal Sterility: • Provided as a ready-to-use, off-the-shelf product that requires no thawing or premixing preparation • Terminal sterilization using electron beam results in a Sterility Assurance Level (SAL) of 10-6 – process BioXpress Graft is not harmful to the DBM or its bioactivity Delivery Device – Some competitive DBM products are only offered as aseptically processed products – SAL of 10-3 • Room temperature storage TM AlloSync DBM Putty Putty, 1 cc ABS-2012-01 Putty, 2.55 cc Putty, 5 cc ABS-2012-02 ABS-2012-05 BioXpress™ Graft Delivery Device Putty, 10 cc ABS-2012-10 The BioXpress graft delivery device is AlloSync DBM Gel designed for targeted delivery of hydrated Gel, 1 cc ABS-2013-01 allograft, autograft, or synthetic bone graft Gel, 5 cc ABS-2013-05 materials to an orthopedic surgical site, Blunt Gel, 10 cc ABS-2013-10 while maximizing material utilization. Tip AlloSync CB DBM Putty BioXpress Graft Delivery Device, Vented Putty, 5 cc ABS-2014-05 Blunt Tip Cannula, 10 cm ABS-10053-10 Putty, 10 cc ABS-2014-10 Angled Tip Cannula, 10 cm ABS-10053-10-45 Angled AlloSync CB DBM Paste Blunt Tip Cannula, 15 cm ABS-10053-15 Tip Paste, 1 cc ABS-2015-01 Angled Tip Cannula, 15 cm ABS-10053-15-45 Paste, 3 cc ABS-2015-03 Paste, 8 cc ABS-2015-08 Cancellous Crushed, 5 cc 27715005 AlloSync bone products are indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. AlloSync bone products are indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender (extremities, spine and pelvis) and as bony void filler of the extremities and pelvis. 9 These defects may be surgically created or from the result of traumatic injury to the bone. AlloSync™ Demineralized Cancellous BONE GRAFTING Sponges and Cortical Fibers Cancellous Sponges Features and Benefits: Demineralized • Every lot poststerilization is tested in vivo to ensure osteoinductivity Cancellous Sponges • Demineralized cancellous matrix comprised of 100% cancellous bone and Cortical Fibers • Maintains natural bone architecture with interconnected porosity • Provides optimal scaffold for cellular attachment and proliferation • Contains exposed natural growth factors with verified osteoinductivity • Naturally absorbs and retains bioactive fluids like platelet-rich plasma (PRP) and bone marrow aspirate (BMA) – After rehydration, the product is compressible like a sponge, allowing for flexibility to fit in and around different types of bone defects • Sterile to device grade standards (10-6) and stored at ambient temperature Cubes Demineralized Cortical Fibers Features and Benefits: • New form of 100% DBM offering excellent handling characteristics without the need for an additional carrier • Osteoconductive and verified osteoinductive properties – The cortical fibers are demineralized using CellRight Technologies’ proprietary process, optimizing the residual calcium level and osteoinductivity Strips – Demineralized cortical fibers provide an optimal scaffold for cellular attachment and proliferation • Customizable hydration: naturally wicks up bioactive fluids such as PRP and BMA • Sterile to device grade standards (10-6) and stored at ambient temperature Cancellous Sponges Cube, 8 mm x 8 mm x 8 mm ABS-2005-01 Cube, 10 mm x 10 mm x 10 mm ABS-2005-02 Cube, 12 mm x 12 mm x 12 mm ABS-2005-03 Chips Strip, 10 mm x 10 mm x 3 mm ABS-2006-01 Strip, 15 mm x 40 mm x 3 mm ABS-2006-02 Strip, 26 mm x 19 mm x 3 mm ABS-2006-03 Strip, 10 mm x 20 mm x 7 mm ABS-2006-04 Chips (1 mm - 4 mm), 1.0 cc ABS-2007-01 Chips (1 mm - 4 mm), 2.5 cc ABS-2007-02 Chips (1 mm - 4 mm), 5 cc ABS-2007-03 Cortical Fibers Fibers Fibers, 1.0 cc ABS-2008-01 Fibers, 2.5 cc ABS-2008-02 Fibers, 5 cc ABS-2008-03 Fibers, 10 cc ABS-2008-04 AlloSync Pure Demineralized Bone Matrix 1.0 cc ABS-2010-01 2.5 cc ABS-2010-02 5.0 cc ABS-2010-05 10 cc ABS-2010-10 AlloSync demineralized strip used to augment an ankle arthrodesis procedure 10 BONE GRAFTING StimuBlast® Demineralized Bone Matrix StimuBlast Bone Products May Provide Osteoinductive and Osteoconductive Properties: • Osteoinduction – signaling molecules such as bone morphogenetic proteins (BMPs) that aid in cell differentiation down osteoblastic pathways • Every lot of demineralized bone matrix (DBM) is tested for osteoinductive potential, using either an in vitro assay or in vivo model • Osteoconduction – scaffolding from DBM particles for osteoblasts to form new bone • Additional scaffolding properties are provided in StimuBlast cancellous bone (CB) with the addition of cancellous bone chips Superior Handling Characteristics via the Reverse Phase Medium (RPM) Carrier: • RPM is an inert, biocompatible co-polymer consisting of polypropylene oxide and polyethylene oxide • Material is flowable at room temperature and thickens to become more viscous at body temperature • RPM allows the DBM graft to be moldable and packed into any defect size or shape • StimuBlast bone products will resist irrigation and can be used in a fluid environment without the fear of graft migration, unlike some other DBMs StimuBlast Bone Products Offer Ease of Use and Terminal Sterility: • Provided as a ready-to-use, off-the-shelf product that requires no thawing or premixing preparation • Terminal sterilization using electron beam results in a Sterility Assurance Level (SAL) of 10-6 – process is not harmful to the DBM or its bioactivity – Some competitive DBM products are only offered as aseptically processed products – SAL of 10-3 • Room temperature storage StimuBlast DBM Putty Putty, 1 cc ABS-2012-01 Putty, 2.55 cc ABS-2012-02 Putty, 5 cc ABS-2012-05 Putty, 10 cc ABS-2012-10 StimuBlast DBM Gel Gel, 1 cc ABS-2013-01 Gel, 5 cc ABS-2013-05 Gel, 10 cc ABS-2013-10 StimuBlast CB DBM Putty Putty, 5 cc ABS-2014-05 Putty, 10 cc ABS-2014-10 StimuBlast CB DBM Paste Paste, 1 cc ABS-2015-01 Paste, 3 cc ABS-2015-03 Paste, 8 cc ABS-2015-08 Cancellous Crushed, 5 cc 27715005 OsteoPrecision Graft Delivery Device - Vented Cannula, 10 cm GD-1115-100 Cannula, 15 cm GD-1115-150 StimuBlast bone products are indicated for orthopedic applications as filler for gaps or voids that are not intrinsic to the stability of the bony structure. StimuBlast bone products are indicated to be packed gently into bony gaps in the skeletal system as a bone graft extender (extremities, spine and 11 pelvis) and as bony void filler of the extremities and pelvis. These defects may be surgically created or from the result of traumatic injury to the bone. Revision Bone Dowels BONE GRAFTING Revision Bone Dowels offer surgeons a quick and effective solution for filling bone tunnels during staged ACL/PCL revision cases. The use of bone dowels provides an immediate structural and biologic architecture for stability and incorporation. Soaking the dowels in PRP or bone marrow concentrate provide an infusion of growth factors and cells to assist with the incorporation of the scaffold. The Revision Bone Dowels were treated with the Allowash XG®* process to clean the scaffold and then preshaped with a tapered tip and cannulated for easier implantation. Treatment with the Preservon®* technology allows for the Revision Bone Dowels to be stored in a prehydrated state for up to five years. Features and Benefits: • Ready to use • Prehydrated with Preservon® technology • 5-year shelf life • 10-6 Sterility Assurance Level • Cannulated • Bullet design D L Length (L) 25 mm-29 mm Length (L) 30 mm-35 mm LifeNet Health LifeNet Health Diameter (D) Part Number Diameter Part Number 9 mm PCD9 9 mm PCDXL9 10 mm PCD10 10 mm PCDXL10 11 mm PCD11 11 mm PCDXL11 12 mm PCD12 12 mm PCDXL12 13 mm PCD13 13 mm PCDXL13 14 mm PCD14 14 mm PCDXL14 16 mm PCD16 16 mm PCDXL16 18 mm PCD18 18 mm PCDXL18 *Allowash XG and Preservon are registered trademarks of LifeNet Health. 12 BONE GRAFTING Quickset™ Calcium Phosphate Cement Features and Benefits: Quickset cement is a macroporous, injectable, hardening, resorbable bone cement provided in an easy-to-use, closed mixing system. Composition: • The mixing system is a dual-chambered syringe containing a powder and mixing liquid • The powder chamber contains a mixture of calcium phosphates and an organic polysaccharide polymer – the polysaccharide is a highly biocompatible polymer that optimizes the viscosity, cohesiveness, and macroporosity iBalance® HTO • The mixing liquid consists of a sodium phosphate solution which facilitates the setting time (crystallization) of the cement • The end product is a calcium-deficient apatite very similar to the mineral phase of bone Physical and Chemical Properties: • Global porosity of 70% – Microporosity (<10 µm): 88% – Mesoporosity (10 -100 µm): 2% – Macroporosity (>100 µm): 10% • Porosity is present by the time it reaches complete hardening Pilon Fracture (24 hours after implantation) • Mechanical compressive strength of 24 MPa (24 hours after implantation) • Excellent cohesiveness, which prevents “wash-out“ by biological fluids • No shrinkage during crystallization • Nonexothermic reaction • Radiopaque Preparation: • Mixing time (room temperature): 2 minutes Calcaneus Fracture • Injection time (room temperature): 2 minutes • Initial setting time (body temperature): 8 minutes – Time it takes for the product to no longer be flowable. Manipulation during this time period is not recommended, as it will affect the crystallization process and final strength characteristics. • Complete hardening (body temperature): 24 hours Arthrex Quickset Cement, 5 cc ABS-3005 Arthrex Quickset Cement, 8 cc ABS-3008 Arthrex Quickset Cement, 16 cc ABS-3016 Quickset cement is intended for bony voids or defects that are not intrinsic to the stability of the bony structure. Quickset cement is intended to be placed or injected into bony voids or gaps of the skeletal system (ie, the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides bone void filler that resorbs and is replaced with bone during the healing process. 13 Arthrex Quickset cement is available in the US as a convenience kit containing Arthrex Quickset cement, a cannula and a delivering gun. Allograft Wedges BONE GRAFTING Allograft bone wedges with cortical/cancellous bone provide the surgeon with a number of options. The high quality bone allografts provide many benefits when compared to autograft iliac crest wedges: no donor site morbidity, no secondary incision site to recover the autograft which reduces the opportunity for an infection, hematoma, or pain at that site and reduced operative time. Allograft Wedges JRF Ortho Part Number Two freeze-dried wedges with the following Osteotomy Wedge Set for HTO 41915001 dimensions are provided in the set: Width = 20 mm High Tibial Osteotomy Length = 50 mm Wedge Height = 17.5 mm OSferion OSferion is an osteoconductive bone graft substitute and bone void filler consisting of 100% high-purity beta-tricalcium phosphate (ß-TCP). OSferion’s micro- and macroporous structure allows it to be resorbed and replaced by bone during the healing process when used in conjunction with rigid fixation devices. OSferion wedges are intended to be used in conjunction with the distal femoral and high tibial opening wedge osteotomy plates and screws to promote healing and provide added rigidity to the repair. Features and Benefits: • Allows for simultaneous controlled absorption and promotion of osteogenesis • Micro- and macroporous structure promotes vascularization14 and the entry of proteins into cells for bone formation15 • Optimum pore diameter facilitates maximum cell infiltration • The material has a compressive force of up to 20 MPa (2900 pounds/inch2) OSferion Trapezoids: • Intended to be used as a bone-patellar tendon-bone (BTB) graft harvest site bone void filler in the patella and tibia • OSferion naturally wicks up autologous blood and/or bone marrow • Can easily be customized using a rongeur or oscillating saw • Clinical studies have shown that the BTB graft harvest site bone void filling reduces the incidence of patella fracture, anterior knee pain, and postoperative kneeling pain OSferion Osteotomy Wedge OSferion Osteotomy Wedge, 7 mm x 30 mm AR-13370-1 OSferion Osteotomy Wedge, 10 mm x 30 mm AR-13370-2 OSferion Osteotomy Wedge, 12 mm x 35 mm AR-13370-3 Arthrex Quickset™ calcium phosphate OSferion Osteotomy Wedge, 15 mm x 35 mm AR-13370-4 cement and OSferion wedge used to fill the bony void created during an OSferion Trapezoid iBalance® HTO procedure. OSferion Trapezoid, 8 x 25 x 7 mm x 75° AR-13372-1 OSferion Trapezoid, 9 x 25 x 7 mm x 75° AR-13372-2 OSferion Trapezoid, 10 x 25 x 7 mm x 75° AR-13372-3 Serial Postoperative X-rays 1 week 3 months 6 months OSferion trapezoid used to fill the bony void that remains after harvesting a BTB graft. 14 CARTILAGE AND MENISCUS BioCartilage® Extracellular Matrix BioCartilage extracellular matrix was designed to provide a reproducible, simple and inexpensive method to augment traditional marrow stimulation procedures. Scientific evidence exists supporting the premise that a dehydrated, allograft-cartilage scaffold used as an adjunct to marrow stimulation should improve the degree and quality of tissue healing within a properly prepared articular cartilage defect.16,17 Primate study indicates repopulation of the defect with hyaline-like cartilage at 12 weeks.18 BioCartilage extracellular matrix is an injectable cartilage-scaffold paste that can fill a cartilage defect subsequent to marrow stimulation. Difficult-to-reach focal defects can be treated open or arthroscopically with a unique delivery system. Features and Benefits Composition: Cartilage Extracellular Matrix • BioCartilage allograft contains the extracellular matrix that is native to articular cartilage including key components such as type II collagen (Figure 1), proteoglycans (Figure 2), and additional cartilaginous growth factors • After processing, the dehydrated allograft cartilage has a particle size of 100 μm-300 μm: – The small particle size improves its injectable nature after it is mixed with an autologous blood solution allowing easier delivery to the defect site – The small particle size also increases the surface area, providing attachment sites for the patient’s bone marrow cells • The principle of BioCartilage extracellular matrix is to serve as a scaffold over an articular cartilage defect providing a tissue network that can potentially signal autologous cellular interactions Figure 1. Immunohistochemistry • Marrow elements will fill the cartilage lesion and interact with the scaffold staining for type II collagen* created by BioCartilage extracellular matrix instead of being expected to create its own fibrin scaffold, as typically anticipated from a marrow stimulation procedure Processing: • BioCartilage extracellular matrix goes through a specialized, gentle dehydration process that allows the water content to be removed • After dehydration, the cartilage advances through a number of proprietary processing steps resulting in a very consistent particle size range Figure 2. Toluidine blue stain • BioCartilage extracellular matrix is a cartilage scaffold that is aseptically highlighting proteoglycan content* processed and packaged to allow for ambient temperature storage with a shelf life of 5 years BioCartilage Extracellular Matrix, 0.75 cc ABS-1007-BC Recommended Accessories BioCartilage Extracellular Matrix, 1 cc ABS-1010-BC Long Tuohy Delivery Needle Mixing and Delivery Kit, Large Joint ABS-1000-L and Obturator ABS-1001-L (Includes Mixing Syringe and Cap, PowerPick™ XL Microfracture Arthroscopic Delivery Needle, Instrument, 45°, 6 mm depth AR-8150PX-45 Obturator, Funnel, Fat Pad Retractor, Gemini SR8 Cannula AR-6572 and Cannulated Swabs) Switching Stick, 2.6 mm x 305 mm AR-6572S Mixing and Delivery Kit, Small Joint ABS-1000-S Chondral Pick, straight 30° tip AR-8655-05 (Includes Mixing Syringe and Cap, Ring Curette, reverse angle AR-8655-04 Arthroscopic Delivery Needle, Noninvasive Ankle Distractor Set AR-1713S Obturator, Funnel, Fat Pad Retractor, Ankle Arthroscopy Distractor Strap AR-1712 and Cannulated Swabs) Ankle Arthroscopy Set AR-8655S 15 *The tissue was stained after the dehydration step 15 Cartiform®* Viable Osteochondral Allograft CARTILAGE AND MENISCUS Cartiform allograft is a cryopreserved osteochondral allograft composed of viable chondrocytes, chondrogenic growth factors and extracellular matrix proteins. While maintaining an intact cartilage structure (Figure 1), the bony portion of the osteochondral allograft is minimal and the graft is porated to offer unique handling characteristics and simple fixation techniques. Cartiform viable osteochondral allograft is recovered with minimal bone and porated for a variety of reasons: • The minimal bone and pores impart flexibility to the allograft, thereby improving handling characteristics for implantation and fixation (Figure 2) • The pores increase the surface area and allow for the proprietary cryopreservative solution to penetrate the tissue Superficial and preserve chondrocyte viability throughout the allograft • The pores facilitate enhanced growth factor release from Cartiform viable osteochondral allograft and allow for progenitor cell migration into the graft following implantation in the osteochondral lesion Transitional Cartiform viable osteochondral allograft combines the safety and success of traditional fresh stored osteochondral allografts with ease of use as the graft is trimmable and flexible to match any lesion size and contour. Radial Stored in a proprietary cryopreservative solution, Cartiform viable osteochondral allograft is readily available with a 2-year shelf life when stored at -80° C. Experimental testing of Cartiform viable osteochondral allograft indicates that >72% cell viability, post-thaw, Osseous is maintained beyond 2 years (Figure 3).19 Figure 1. Structural organization Cartiform Viable Osteochondral Allograft, 10 mm Disc ABS-1101-10 of Cartiform allograft. Cartiform Cartiform Viable Osteochondral Allograft, 12 mm x 19 mm ABS-1102-19 viable osteochondral allograft Cartiform Viable Osteochondral Allograft, 20 mm Disc ABS-1101-20 preserves the microstructure of Cartiform Viable Osteochondral Allograft, 20 mm x 25 mm ABS-1102-25 3 distinct cartilage zones (super- ficial, transitional or radial) and an osseous layer as evident on histological staining (H&E). A Figure 3. Live (green) and dead (red) cell-staining of Cartiform unit post-thaw after 2.7 years storage at -80° C, 70% cell viability. B C Figure 2. Appearance of Cartiform viable osteochondral allograft (20 mm diameter size): top (A), bottom (B), and side (C) views. Note the score mark distinguishing the bottom (bone) side (outlined with black Fixation of Cartiform viable osteochondral allograft in box in B and the flexibility that enables the trochlea is achieved with the Knotless SutureTak® folding in C). percutaneous insertion kits. 16 CARTILAGE AND MENISCUS Autograft OATS® Set The Autograft OATS (Osteochondral Autograft Transfer System) technique is an excellent procedure for the repair of small osteochondral defects of the knee. Surgeons may use single-use OATS instrumentation to facilitate the harvest of osteochondral/hyaline cartilage cores from a donor site superior and lateral to the notch or above the sulcus terminalis. Single-Use OATS Set, 4.75 mm AR-1981-04S Single-Use OATS Set, 6 mm AR-1981-06S Single-Use OATS Set, 8 mm AR-1981-08S Single-Use OATS Set, 10 mm AR-1981-10S OATS Sizer/Tamps Instrumentation Set AR-1985S Set includes a size-specific sizer/tamp within each package Single-Use OATS Set Small Joint OATS® Sets The Small Joint Osteochondral Autograft Transfer System (OATS) kit is a sterile, single-use set for the removal of osteochondral defects and transfer of autograft plugs to replace the defect. The set includes everything needed to perform this procedure on either the talus or the metatarsals. The defect at the recipient site is drilled out using the guide pin and cannulated drill. The graft plug is harvested from a donor site to a controlled depth just longer than the depth of the drill hole at the recipient site. The graft plug is trimmed to length and press-fit into the recipient site with an extruder and/or tamp. Cartilage Replaces Cartilage – Whether harvesting from the patient or an allograft, Small Joint OATS Set the patient will have a natural bearing surface Straightforward Reliable Technique – The well- documented success of the OATS procedure is, in large part, due to the ease of use of this set Sterile, Single-Use Set – Ensures that all the necessary instruments are present and ready Small Joint OATS Set, 6 mm AR-8981-06S Small Joint OATS Set, 8 mm AR-8981-08S Small Joint OATS Set, 10 mm AR-8981-10S Metatarsal and Talar OATS Technique 17 CARTILAGE AND MENISCUS OATS® AlloPlug and AlloSync™ Cancellous Plugs Surgeons concerned about possible donor site morbidity, caused by leaving the donor site sockets open, may now use these specially designed OATS AlloPlug backfill plugs to fill the donor site and promote natural bone healing for a complete biologic repair. AlloPlugs are processed from the articular surface, resulting in a multiphasic plug composed of a dense cancellous layer, a cortical layer, and a cartilage layer. These plugs come in a range of sizes from 7 mm-11 mm in diameter and 16 mm in length. AlloSync cancellous plugs are comprised of 100% human cancellous bone for use in backfill and bone void procedures. These plugs are provided sterile via the Allowash XG®* process and stored in Preservon®*, a proprietary glycerol-based preservation technology that allows allografts to be stored in a fully hydrated state at ambient temperature. Preservon preservation technology eliminates the lengthy thawing and rehydrating times and does not require freezer storage. These plugs are available in sizes from 6 mm-11 mm in diameter and 16 mm in length. When selecting a graft for backfill applications, the implant should be sized 1 mm larger than the OATS core harvested. For example, in a case where an 8 mm OATS Harvester is used, a 9 mm Allograft Plug is used to provide a line-to-line fit in the donor site. An additional Allograft Plug Delivery Sleeve may be ordered to facilitate implantation of the plug. Arthrex LifeNet Health Part Number Part Number AlloPlug Frozen Backfill Plug w/Cartilage, 7 mm FCPD7 AlloPlug Frozen Backfill Plug w/Cartilage, 8 mm FCPD8 AlloPlug Frozen Backfill Plug w/Cartilage, 9 mm FCPD9 AlloPlug Frozen Backfill Plug w/Cartilage, 10 mm FCPD10 AlloPlug Frozen Backfill Plug w/Cartilage, 11 mm FCPD11 AlloSync Cancellous Plug, 6 mm PCPD6 AlloSync Cancellous Plug, 7 mm PCPD7 AlloSync Cancellous Plug, 8 mm PCPD8 AlloSync Cancellous Plug, 9 mm PCPD9 AlloSync Cancellous Plug, 10 mm PCPD10 AlloSync Cancellous Plug, 11 mm PCPD11 Allograft Plug Delivery Sleeve, 7 mm AR-1981BI-07 Allograft Plug Delivery Sleeve, 9 mm AR-1981BI-09 Allograft Plug Delivery Sleeve, 11 mm AR-1981BI-11 Allograft Plug Delivery Sleeve • Cartilage • Cortical Bone • Cancellous Bone *Allowash XG and Preservon are registered trademarks of LifeNet Health. 18 CARTILAGE AND MENISCUS Fresh Cartilage Arthrex has a long-standing partnership with leading tissue banks to provide fresh osteochondral allografts (OCA) for use in joint restoration procedures. Fresh OCAs allow the surgeon to transplant mature, hyaline cartilage with viable chondrocytes and subchondral bone in a single procedure. JRF Ortho LifeNet Health Upper Extremity/Shoulder Part Number Part Number Humeral Head, Right 41247001 HHR80 Humeral Head, Left 41247002 HHL80 Elbow Distal Humerus, Right 44647001 Distal Humerus, Left 44647002 Proximal Ulna, Right 45847001 Lateral Partial Lateral Femoral Proximal Ulna, Left 45847002 Hemi-Condyle Hemi-Condyle Lower Extremity/Hip Femoral Head, Right 41847001 FHR80 Femoral Head, Left 41847002 FHL80 Knee Medial Partial Hemi-Condyle, Right 43647001 PCC80 Medial Partial Hemi-Condyle, Left 43647002 PCB80 Lateral Partial Hemi-Condyle, Right 43747001 PCD80 Lateral Partial Hemi-Condyle, Left 43747002 PCA80 Medial Femoral Hemi-Condyle, Right 32247001 FCC80 Medial Hemi-Tibial Medial Femoral Hemi-Condyle, Left 32247002 FCB80 Plateau w/Meniscus Lateral Femoral Hemi-Condyle, Right 32147001 FCD80 Lateral Femoral Hemi-Condyle, Left 32147002 FCA80 Patella Bone Whole Femoral Condyle, Right 33547001 FCR80 w/Attachment Whole Femoral Condyle, Left 33547002 FCL80 Femoral Trochlea, Right 43547001 FTR80 Femoral Trochlea, Left 43547002 FTL80 BiCompartment, Right Lateral and Trochlea 43747003 FTD80 BiCompartment, Left Lateral and Trochlea 43747004 FTA80 Distal Tibia BiCompartment, Right Medial and Trochlea 43647003 FTC80 BiCompartment, Left Medial Humeral Head and Trochlea 43647004 FTB80 Medial Hemi-Tibial Plateau w/Meniscus, Right 44947001 Medial Hemi-Tibial Plateau w/Meniscus, Left 44947002 Lateral Hemi-Tibial Plateau Femoral Trochlea Talus w/Meniscus, Right 45047001 Lateral Hemi-Tibial Plateau w/Meniscus, Left 45047002 Whole Tibial Plateau w/Meniscus, Right 32447001 TFR80 Precut, fresh OCA Core Whole Tibial Plateau w/Meniscus, Left 32447002 TFL80 Patella Bone w/Attachment, Right 33647001 PAR80 Patella Bone w/Attachment, Left 33647002 PAL80 Foot and Ankle Distal Tibia, Right 32747001 TDR80 Distal Tibia, Left 32747002 TDL80 Talus, Right 32647001 ATR80 Talus, Left 32647002 ATL80 Proximal Metatarsal Bone, Right 44747001 Proximal Metatarsal Bone, Left 44747002 Distal Metatarsal Bone, Right 44847001 Distal Metatarsal Bone, Left 44847002 JRF Ortho Ordering Information Precut Osteochondral Core, Fresh, 10 mm 45647010 Precut Fresh Osteochondral Precut Osteochondral Core, Fresh, 15 mm 45647015 Allograft Cores Precut osteochondral allograft (OCA) cores provide a biologic and structural repair for full thickness osteochondral lesions. The OCA cores provide the optimal architecture, biomechanical support, and viable hyaline cartilage to support the repair during healing. The availability of fresh OCA cores now provides surgeons with a convenient and new tool in their cartilage treatment regimen without the challenge of harvesting sufficient and suitable autologous donor cartilage. 19 Allograft OATS® System CARTILAGE AND MENISCUS The Allograft OATS system can be used for intraoperative harvesting of 15 mm–35 mm-diameter cores from fresh allografts. There are few treatment options for patients with large symptomatic lesions of osteoarticular surfaces. Using allografts for osteoarticular resurfacing gives surgeons the ability to match the contour and cartilage morphology of the recipient site, while avoiding multiple surgical sites and the possible donor site morbidity associated with recovering an autograft from the knee. Fresh grafts are stored in a proprietary storage media and maintained at 4º C. These grafts should be implanted as soon as possible to have the highest levels of viable chondrocytes. The Allograft OATS Instrumentation Set is provided at no charge when working with your Arthrex Technology Consultant to secure a fresh talus through an Arthrex tissue partner. Allograft OATS Instrument Set AR-4075S 20 CARTILAGE AND MENISCUS BioUni™ OATS® Instrument Set The BioUni OATS Instrument Set is the new standard for restoration of the articular surface when presented with elongated cartilage defects in the medial femoral condyle. Through a series of precisely designed cutting instruments, surgeons can replace damaged cartilage with a single, elliptical piece of viable, hyaline cartilage. The BioUni instruments address many of the challenges and risks associated with the recovery and implantation of multiple small and large cartilage cores. Overlapping multiple cores adds complexity of curve matching, fit and surgical time for each procedure. The BioUni instruments were designed to match the natural curvature of the femoral condyle to remove those complexities. Multiple sizes allow flexibility for the surgeon to adjust the width and length of the cartilage defect and to ensure proper restoration of the articular surface with a single cartilage piece. BioUni OATS Instrument Set AR-4080S Accessories PowerPick™ Microfracture Instrument, 45’ 6 mm Depth AR-8150PX-45 PowerPick Microfracture Instrument, 30’ 4 mm Depth AR-8150PP-30 PowerPick Microfracture Instrument, 45’, 6 mm Depth (5 pack) AR-8150PP-45 Autologous Conditioned Plasma (ACP) ABS-10010S AlloSync™ Gel, 1 cc ABS-2002-01 AlloSync Gel, 5 cc ABS-2002-05 Final look at the BioUni cartilage 21 Talus OATS® Instrumentation Set CARTILAGE AND MENISCUS The Talus OATS Instrumentation Set facilitates harvesting of small diameter (6 mm-12 mm) osteochondral/ hyaline cartilage cylinders from an allograft bone. The core is made by placing the fresh talus into the workstation and harvesting it with the donor harvester. A recipient socket is created 0.5 mm undersized with the appropriately sized recipient harvester. The exact depth of the allograft, to match the socket, is obtained with the Depth Measurement Guide and the allograft is trimmed to the same depth and obliquity. Dilation of the socket results in a line-to-line fit once the donor allograft is inserted into the recipient socket. Final seating of the allograft is achieved with an oversized tamp, resulting in a perfectly flush, press-fit graft that does not require fixation implants. The Talus OATS Instrumentation Set is provided at no charge when working with your Arthrex Technology Consultant to secure a fresh talus through an Arthrex tissue partner. Talus OATS Instrument Set AR-8900S Meniscus Allografts Better understanding of the biomechanical consequences of total and partial meniscectomy has led surgeons to explore methods of meniscus preservation. However, in many cases, the damage is far too extensive to preserve the meniscus and few options exist for these patients. Meniscal allografts have proven to be effective in improving function and reducing pain for selected patients with a meniscus-deficient knee. Arthrex can provide medial and lateral meniscal allografts that come with sufficient bone block to perform various anchorage procedures including double-bone plug, keyhole and dovetail technique. Meniscal allografts are most commonly used in symptomatic patients with prior meniscectomy and persistent pain. Patients should have normal alignment and should not have articular damage greater than grade III. Serious articular disease, osteophyte formation or flattening of the femoral condyle are common contraindications for meniscal transplant. JRF Ortho Part Number LifeNet Health Part Number Lateral Meniscus, Right 28325001 FMN RL Lateral Meniscus, Left 28325002 FMN LL Medial Meniscus, Right 28225001 FMN RM Medial Meniscus, Left 28225002 FMN LM Meniscal allograft tissue is also available upon request for nonknee transplantation such as carpometacarpal or metatarsophalangeal joint procedures. 22 CARTILAGE AND MENISCUS Meniscal Implantation Techniques Meniscal allografts have been found to be a feasible alternative in the effort to limit sequelae of arthritis that can occur with meniscal excision. The surgical technique for meniscal allograft transplantation of the knee continues to evolve. Simplified graft preparation and recipient tibia preparation – to allow for the transplant to be positioned anatomically and anchored with reliable fixation – is the ultimate goal of the procedure. Double-Bone Plug Meniscal Reconstruction The double-bone plug technique for meniscal allograft reconstruction provides a method for implanting the meniscal allograft with rigid fixation at the horn attachments. It has been demonstrated that bony fixation at the attachment site allows for the maintenance of functional hoop stress by the meniscal allograft.20 RetroConstruction Drill Guide Set AR-1510S Dovetail Meniscal Reconstruction The dovetail technique simplifies graft preparation with a time-saving series of cuts preparing the bone component of the graft to sit securely in the recipient semitrapezoidal slot created in the tibia. A matching semitrapezoidal-shaped recipient slot created in the tibia with a series of step drills, rasps and dilators matches the bone block preparation. A “box” technique that requires an interference screw fixation is also available The Dovetail Meniscal Allograft Instrumentation Set is provided at no charge when working with your Arthrex Technology Consultant to secure a meniscus allograft. 23 For more information about these meniscal implantation techniques, please access www.Arthrex.com. Arthrex Amnion™ Matrix and Viscous SOFT TISSUE Amniotic-derived tissues contain regenerative qualities and growth factors that maintain the natural healing properties of Amnion. Arthrex Amnion Matrix is an anatomical barrier that helps provide mechanical protection to prevent adhesion and scar formation while supporting healing with nutrient-rich growth factors. • Protection: Used as an adhesion barrier to help protect tendons and nerves. For homologous use only. • Regenerative: High concentration of growth factors that reduce inflammation and scarring • Easy to use: Membranes are rehydrated quickly in the surgical site • Convenient: Ambient storage (membranes) with a 5-year shelf life • Safe: Recovered aseptically and DMSO free Applications and Benefits: • Tendon or nerve wrap Arthrex Amnion Matrix - Cord • Adhesion barrier • Reduces scar formation • Growth factors direct to site • Rich in growth factors Arthrex Amnion Matrix extracellular membrane is available in 2 thicknesses and a variety of sizes: Arthrex Amnion Matrix - Thin Arthrex Amnion Matrix - Cord This traditional single layer is a semitransparent Approximately 8x thicker than traditional Amnion, collagenous membrane approximately 100 μm- Arthrex Amnion Matrix - Cord can be sutured and 300 μm in thickness. As with the thicker version, is easy to handle. Arthrex Amnion Matrix - Cord is Arthrex Amnion Matrix - Thin is intended for use derived from the umbilical cord and is approximately as a soft-tissue barrier or wound covering. 8x thicker than Arthrex Amnion Matrix - Thin, which allows for suturing and easy handling. 2 cm x 2 cm ABS-4100-022 2 cm x 3 cm ABS-4100-023 2 cm x 2 cm ABS-4200-022 4 cm x 4 cm ABS-4100-044 2 cm x 3 cm ABS-4200-023 4 cm x 6 cm ABS-4100-046 3 cm x 4 cm ABS-4200-034 7 cm x 7 cm ABS-4100-077 3 cm x 6 cm ABS-4200-036 3 cm x 8 cm ABS-4200-038 Arthrex Amnion Viscous is amniotic fluid that contains a broad spectrum of growth factors and cytokines that play an important role in wound healing, cell proliferation, tissue protection and repair.21 Arthrex Amnion Viscous is available in convenient sizes for a variety of applications and has a 2-year shelf life. 0.5 cc ABS-4300-050 1.0 cc ABS-4300-100 2.0 cc ABS-4300-200 24 SOFT TISSUE ArthroFLEX®* Dermal Allograft ArthroFLEX dermal allograft is an acellular dermal extracellular matrix intended for supplemental support and covering for soft-tissue repair. MatrACELL®* decellularized dermis, a patented and validated process by LifeNet Health®, renders the ArthroFLEX allograft dermis acellular, without compromising biomechanical or biochemical properties. This process allows the matrix to retain its growth factors, native collagen scaffold, and elastin, which are required for healing. This patented and validated process renders allograft bioimplants acellular, without compromising the biomechanical or desired biochemical properties of an allograft bioimplant for its intended surgical application. Features and Benefits: • An intact acellular matrix of collagen, elastin, and growth factors provides a clean scaffold intended for supplemental support and covering for soft-tissue repair • Elastin and collagen provide unparalleled strength for supplemental support and covering for soft-tissue repair • Short processing time reduces the opportunity for water-mediated lysis of the natural collagen and elastin scaffold • MatrACELL decellularized dermis removes donor DNA from the dermal matrix, ensuring a biocompatible scaffold to facilitate repair • Uses a validated DNA assessment method, able to detect as little as one nanogram (ng/mL) of nucleic acid to ensure the tissue has been decellularized • Uses multiple disinfecting agents to provide comprehensive tissue disinfection • Terminally sterilized with a 3-year shelf life LifeNet Health Part Number Decellularized Dermis, 35 mm x 35 mm x 1.5 mm AFLEX100 Decellularized Dermis, 40 mm x 70 mm x 1.5 mm AFLEX101 Decellularized Dermis, 35 mm x 35 mm x 2.0 mm AFLEX200 Decellularized Dermis, 40 mm x 40 mm x 1.0 mm AFLEX400 Decellularized Dermis, 40 mm x 70 mm x 1.0 mm AFLEX401 Decellularized Dermis, 15 mm x 140 mm x 1.5 mm AFLEX150 Decellularized Dermis, 50 mm x 90 mm x 1.5 mm AFLEX103 Decellularized Dermis, 30 mm x 40 mm x .5 mm AFLEX500 Decellularized Dermis, 40 mm x 70 mm x 2.0 mm AFLEX201 Decellularized Dermis, 40 mm x 70 mm x 3.0 mm AFLEX301 BioWashers, 10 mm x 14 mm x 2.0 mm AFLEX822 Superior Capsular Reconstruction *ArthroFLEX and MatrACELL BioWasher® Human Allograft Tissue are registered trademarks OR Human Dermal Tissue AFLEX-822 25 of LifeNet Health. Arthrex DX Reinforcement Matrix SOFT TISSUE The Arthrex DX Reinforcement Matrix is a dermal extracellular matrix (ECM) that has been created as a biomechanically strong and biocompatible scaffold for the reinforcement and repair of soft tissues. By maintaining the natural 3D structure and natural vascular channels through the OPTRIX™* processing technology, Arthrex is providing a sterile, ready-to-use, biologically intact scaffold while maintaining essential matrix components such as collagen, elastin, glycoproteins, glycosaminoglycans, and proteoglycans. Collagen Features and Benefits: Provides strength and structural support • Retains native matrix structure for superior strength and support for cellular migration22 • Removes antigenic components, while maintaining high level of collagen structure Glycosaminoglycans Elastin • Porous, open structure providing a scaffold for cell ingrowth Mediates cell Provides elasticity communication for the tissues • Excellent strength without crosslinking • Higher modulus than competitive products22 • Validated preservation of ECM proteins and growth factors22 • Convenience – Room temperature storage – Prehydrated – No preparation time Glycoproteins Proteoglycans – Two-year shelf life Promotes cell Sequesters growth attachment factors • Safety – Sterile – Reduced a-Gal antigen – Biocompatible Arthrex DX Reinforcement Matrix Components – OPTRIX™ process – Every lot tested to confirm DNA and cellular removal – Retains biologic integrity Decellularized Xenograft Dermis, Hydrated 5.0 cm x 5.0 cm x 1.5 mm ABS-30001S Decellularized Xenograft Dermis, Hydrated 6.0 cm x 8.0 cm x 1.5 mm ABS-30002S The Arthrex DX Reinforcement Matrix is supplied sterile and comes prehydrated, with saline already in the package, and ready to use. SpeedBridge™ RCR with DX Reinforcement Matrix *OPTRIX is a trademark of DSM. 26 SOFT TISSUE Tendon Allografts – Construct Grafts Use of allograft tendons for primary and revision ACL and PCL reconstructions reduces OR time and eliminates the risk of donor site morbidity. Other uses of allograft tendons include reconstruction of the medial and lateral collateral ligaments of the knee (MCL, LCL), elbow ligament reconstruction, and medial and lateral ankle stabilization procedures, just to list a few. Tendons offered by Arthrex are provided sterile from tissue bank alliance partners. The processing methods used render the tissue sterile without compromising the biomechanical or biochemical properties of the tissue. Construct Grafts JRF Ortho Part Number LifeNet Health Part Number Presutured Allograft GraftLink® Construct FGL Presutured Lateral Ankle Tendon LAT-001 FPSST JRF GraftLink XL Construct (PCL) GRX-001 KinetiGraft BTB Construct FKG10 SpeedGraft® Construct SPD-001 VersaGraft® Construct VRG-001 ACL Reconstruction using the Presutured Allograft GraftLink® Construct VersaGraft® Presutured Tendon for Lateral Ankle Reconstruction SpeedGraft® Presutured Double-Stranded Tendon Lateral Ankle Reconstruction with the Presutured Lateral Ankle Tendon 27 Not all products are available in Canada. Tendon Allografts – Standard Grafts SOFT TISSUE Use of allograft tendons for primary and revision ACL and PCL reconstructions reduces OR time and eliminates the risk of donor site morbidity.23 JRF Ortho Part Number Standard Grafts Allosource /CTS LifeNet Health Part Number Achilles Tendon w/ Bone Block 10017000/1025-14 FATB Achilles Tendon w/o Bone Block 1085-14 FAT All-Inside Single/Anterior Tibialis Tendon D = 8.0 mm-11.0 mm, L = 170 mm-200 mm FANT-SL All-Inside Single/Posterior Tibialis Tendon D = 8.0 mm-11.0 mm, L = 170 mm-200 mm FPOST-SL All-Inside Single/Peroneus Longus Tendon D = 8.0 mm-11.0 mm, L = 170 mm-200 mm FPLT-SL All-Inside Double D = 1 ea 6.0 mm + 1 ea 5 mm-7 mm, L = 170 mm-200 mm FDBLTEND Anterior Tibialis Tendon 1020-14 FANT/TIB/T Double Bundle Tibialis Tendon FDBLTEND Extensor Mechanism, Right 24818001 Extensor Mechanism, Left 24818002 Gracilis, Double Strand 26217000/1009-14 Osteotomy Wedge, Pair 41915001 Patellar Tendon, Bisected/Hemi 1781700/1166-14 FBPL Patellar Tendon, Bisected, Small Block FBPLSB Patellar Tendon, Whole 17917000/1165-14 FWPL Patellar Tendon, Whole - Small Block FWPLSB Patellar Tendon, Whole with Quadriceps 1013-14 FWPLQ Peroneus Longus, Double Strand 43917000/1170-14 Peroneus Tendon 1170-14 FPLT Pre-Shaped Achilles, 10 mm 10017100/1967-14 FATB10 Pre-Shaped Achilles, 11 mm 1968-14 FATB11 Pre-Shaped Patellar Tendon, 10 mm 18017000/1964-14 FPL10 Pre-Shaped Patellar Tendon, 11 mm 1965-14 FPL11 Posterior Tibialis Tendon 1021-14 FPOST.TIBIAL Quadruple Strand Semitendinosus/Gracilis 42217002/1501-14 Quadruple Strand Tibialis 44217000 Quadruple Strand Peroneous Longus 44217004 Quadriceps Tendon w/Bone 1903-14 Rotator Cuff Patch Graft 47015000 Semi-Tendinosus, Double Strand 18717000/1014-14 Semi-Tendinosus and Gracilis Tendons 1501-14 1FST+1FGRACILIS Semi-Tendinosus Tendon Min L = 230 mm, Min D > 4.0 mm 1014-14 FST Semi-Tendinosus Tendon L = 160 mm-180 mm, D = 4 mm-6 mm 44317003/1824-14 FSTP Tibialis, Anterior, Double Strand 41517000/1020-14 Tibialis, Posterior, Double Strand 41617000/1021-14 Anterior Tibialis Tendon/Small Joint 44317000 FANT-SL Gracilis Tendon/Small Joint 44317002 FGRACILIS Peroneus Longus/Small Joint 44317002 FPLT-SL Posterior Tibialis Tendon/Small Joint 44317001 FPOST-SL Fascia Lata, Small 30 mm x 60 mm FL S Fascia Lata, Medium 30 mm x 150 mm FL M Fascia Lata, Large 80 mm x 200 mm FL L RC Allograft Patch, Size Varies - 2.0 mm-25 mm x 2.0 mm-2.5 mm 47015000 GraftRope FROPE ACL Graft Fixation with TightRope® RT and GraftLink® Construct Tibialis Tendons 28 WOUND CARE JumpStart® Antimicrobial Wound Dressing JumpStart is a microcurrent-generating antimicrobial wound dressing designed to mimic the body’s natural physiologic electric currents. Used in multiple clinical applications, JumpStart dressing provides sustained broad-spectrum antimicrobial24 efficacy and an optimal environment for wound healing. The Technology The dot matrix pattern of silver and zinc microcell batteries embedded on the dressing generate microcurrents in the presence of a conductive medium, such as sterile saline, water, hydrogel, or wound exudate. JumpStart dressings are provided on an ultrathin, lightweight, polyester substrate and contain laser-cut fenestration to allow easy passage of wound exudate into the absorbent layer or a secondary dressing. The flexible design easily contours to the body. JumpStart dressings may be applied directly over sutures, staples, Steri-Strip™* skin closures and liquid skin adhesives. JumpStart Composite Dressing Foam Layer Electricity acts as a guidance signal to initiate • Absorbent for effective cell migration and reepithelialization. exudate management Published data on file.28 JumpStart Contact Layer Dressing • Multiple sizes available to fit surgical and wound sites • Conforms easily to body contours for patient comfort • Can be cut to fit under secondary dressings Adhesive Layer • High performance and waterproof for multiday wear • Ergonomic shape conforms easily to body contours for adherence and patient comfort Technology JumpStart Contact Layer Dressing Layer Dressing Size (in) Qty/Box Arthrex Part# 1 x 1 Fenestrated 10 ABS-4001 Dot matrix of elemental 1.5 x 8 10 ABS-4005 silver and zinc create 1.5 x 10 10 ABS-4006 microcell batteries that 2 x 2 10 ABS-4002 generate microcurrents in the 2 x 5 10 ABS-4025 presence of a conductive 3 x 3 10 ABS-4003 medium. 4 x 4 10 ABS-4004 8 x 8 1 ABS-4008 12 x 12 1 ABS-4012 Broad Spectrum Antimicrobial Efficacy JumpStart Composite Dressing JumpStart dressing’s antimicrobial protection Adhesive Size (in) Dressing Size (in) Qty/Box Arthrex Part# creates an optimal environment for wound healing.24-27 2.5 Diameter 1.0 Diameter 10 ABS-4054 • Kills a broad spectrum of harmful pathogens, including 4.0 Diameter 2.0 Diameter 10 ABS-4056 multidrug resistant21 and biofilm-forming bacteria25-27 4 x 4 2 x 2 5 ABS-4053 to help reduce risk of infection 5 x 6 1.5 x 5 5 ABS-4051 4.5 x 10 1.5 x 7 5 ABS-4052 • No silver release into the bloodstream29 6 x 11.5 2 x 9 5 ABS-4050 29 *Steri-Strip is a trademark of 3M. ProWick®* Postoperative Dressing and Cold Therapy System WOUND CARE The ProWick shoulder postoperative dressing and cold therapy system is revolutionary technology designed to meet the demands of arthroscopic and mini open surgical techniques. ProWick systems feature a tapeless design composed of state-of-the-art, super-absorbent material that stores patient exudate away from the surgical incision sites while compression and cold therapy are applied to the healing joint. Features and Benefits: c • Super-Absorbent: Hydrophilic foam islands cover d incision sites and channel fluid into the super-absorbent cover dressing, a fluid reservoir • Compression: Conforming strap gently compresses swollen joint and secures cover dressing to the body, eliminating the need for tape • Efficient Cold Therapy: Cold therapy takes advantage of the thin ProWick dressing system, creating an e b effective alternative to traditional bulky dressings a The Sterile ProWick Shoulder Sterile ProWick Shoulder Dressing System Dressing System Includes: • Two foam islands (a) Foam Islands: • Super-absorbent cover dressing (b) • Hydrophilic foam islands absorb fluid into the cover dressing and away from incision sites, minimizing pooling • Three conforming compression straps (c) • Reusable cold therapy wrap (d) Super-Absorbent Cover Dressing (Fluid Reservoir): • Five waterproof bandages for • Triple-layer dressing stores exudate away from incision sites post-dressing home use (e) • Ultralow profile reduces bulk, enabling effective cold therapy • Absorbs several ounces of fluid Compression Straps: • Secures dressing without tape; no painful tape removal • Applies light compression and provides joint support • Conforms to joint as swelling decreases, so dressing stays comfortably in place Compression Strap Super-Absorbent Cold Pack: Cover Dressing • Cost-effective reusable cold therapy Foam Island • Cold therapy easily penetrates low-profile cover dressing • Enables patient mobility while cold therapy is applied Waterproof Bandages: • Keep incisions clean and dry after removal of cover dressing • Conveniently packaged to send home with patient Foam islands channel ProWick Shoulder Postoperative Dressing and Cold Therapy System AR-1625P exudate from incision (box of 10, packed individually, sterile) and into cover dressing ProWick Knee Postoperative Dressing and Cold Therapy System AR-1626P (box of 10, packed individually, sterile) *ProWick is a registered trademark of Redyns Medical LLC. 30 REFERENCES References 1. 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Connolly JF, Guse R, Tiedeman J, Dehne R. Autologous marrow injection as a substitute for operative grafting of tibial nonunions. Clin Orthop Relat Res. 1991;(266):259-270. 7. Lim JK, Hui J, Li L, Thambyah A, Goh J, Lee EH. Enhancement of tendon graft osteointegration using mesenchymal stem cells in a rabbit model of anterior cruciate ligament reconstruction. Arthroscopy. 2004;20(9):899-910. doi:10.1016/j.arthro.2004.06.035. 8. Ouyang HW, Goh JC, Lee EH. Use of bone marrow stromal cells for tendon graft-to-bone healing: Histological and immunohistochemical studies in a rabbit model. Am J Sports Med. 2004;32(2):321-327. doi:10.1177/0095399703258682. 9. Choi LS, Ma R, Zeng Q, et al. Bone marrow aspirate with or without platelet concentrates as a bone graft substitute for posterolateral spinal fusion: A randomized, controlled study using an animal model. 52nd Annual Meeting of the Orthopedic Research Society. Paper No: 1742. 10. Pountos I, Jones E, Tzioupis C, McGonagle D, Giannoudis PV. Growing bone and cartilage: the role of mesenchymal stem cells. J Bone Joint Surg (Br). 2006;88-B:421-426. doi:10.1302/0301-620X.88B4. 1 1 . Hernigou P, Poignard A, Beaujean F, Rouard H. Percutaneous autologous bone-marrow grafting for nonunions. Influence of the number and concentration of progenitor cells. J Bone Joint Surg Am. 2005;87(7):1430-1437. doi:10.2106/JBJS.D.02215. 12. Sánchez M, Delgado D, Sánchez P, et al. Combination of intra-articular and intraosseous injections of platelet rich plasma for severe knee osteoarthritis: a pilot study [published online July 4, 2016]. Biomed Res Int. doi:10.1155/2016/4868613. 13. CellRight Technologies, LLC. Data on file (ConCelltrate® 100 Histology and In-Vitro Alkaline Phosphate Induction Assay). Universal City, TX; 2017. 14. Tanaka T1, Kumagae Y, Saito M, et al. Bone formation and resorption in patients after implantation of beta-tricalcium phosphate blocks with 60% and 75% porosity in opening-wedge high tibial osteotomy. 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Measurement of microelectric potentials for a bioelectrically-active wound care device in the presence of bacteria. J Wound Care. 2015;24(1):23-33. doi:10.12968/jowc.2015.24.1.23. To order products, please call Arthrex at: 1.800.934.4404 31 ORTHOBIOLOGICS OVERVIEW The market for orthobiologics is continually gaining attention owing to the compelling benefits of cellular therapies, allografts, and innovative technologies in expediting skeletal and tissue healing. Focused on patient safety and clinical outcomes, Arthrex is leading the way in the field of orthobiologics. Additionally, we are developing new technologies with potential multispecialty applications. We will continue to develop a wide range of innovative products to strengthen our portfolio and to help surgeons treat their patients better. This description of technique is provided as an educational tool and clinical aid to assist properly licensed medical professionals in the usage of specific Arthrex products. As part of this professional usage, the medical professional must use their professional judgment in making any final determinations in product usage and technique. In doing so, the medical professional should rely on their own training and experience and should conduct a thorough review of pertinent medical literature and the product’s Directions For Use. Postoperative management is patient specific and dependent on the treating professional’s assessment. Individual results will vary and not all patients will experience the same postoperative activity level or outcomes. View U.S. Patent information at www.arthrex.com/corporate/virtual-patent-marking © 2018 Arthrex, Inc. All rights reserved. LB1-0804-EN_I