Biomet Sports Medicine, a wholly owned subsidiary of Biomet, Inc., entered the arthroscopy market in 1990 when it purchased the assets of Arrow Surgical Technologies, Inc. of San Dimas, California. Today the product line offering includes more than 3,000 products to address the $1.2 billion worldwide market. Working in conjunction with the industry’s most innovative surgeons, Biomet Sports Medicine is now focusing its research and development efforts on technique-specific instruments and implants for anterior cruciate ligament (ACL) reconstruction and arthroscopic shoulder repairs. Along with the development of new products for the Warsaw, Indiana arthroscopic industry, Biomet Sports Medicine invests heavily in surgeon education, providing them hands-on learning opportunities to keep them current in modern arthroscopic surgical procedures. The Biomet Sports Medicine Sales Force is likewise educated to become an informational asset for surgeons. Training takes place in two state-of-the-art cadaver labs, one in Warsaw, Indiana and the other in Ontario, California. Biomet Sports Medicine is headquartered in Warsaw, Indiana within the Biomet, Inc. home office. California is the home of Biomet Sports Medicine’s instruments and implants manufacturing site in Ontario and capital equipment in Redding. Shipping of finished goods comes from each of these three locations specific to the products that are produced there. Biomet Sports Medicine is pleased to offer the most advanced arthroscopic products available today. Should you have questions regarding the product line or would like to have a Sales Representative contact you, please call the Corporate Headquarters at 800.348.9500 ext. 1501 for information. Howell™ 65˚ Tibial Guide • Aids in the prevention of PCL impingement • Aids in the prevention of roof impingement without performing a roofplasty • Allows for replication of the tension pattern of the intact ACL Fanelli PCL/ACL Guide ™ • Adjustable guide facilitates accurate and reproducible tunnel placement for PCL and ACL reconstruction • One guide used for both tibial and femoral tunnels in PCL reconstruction Autogenous Bone Coring System • Allows for the harvesting of bone plugs from both the tibial and transverse tunnels for later implantation in ACL surgery • Positions autogenous bone in femoral and tibial tunnels near the joint aperture • Increases the strength and stiffness of fixation in soft tissue ACL reconstruction • Harvest a bone plug that can be used to replace the patella and tibial defects in Bone-Patellar Tendon-Bone ACL reconstructions Fanelli™ System Instruments • Unique instruments protect the neurovascular structures at the posterior aspect of the knee. KNEES Graft Tensioning Boot • Self retaining tensioner eliminates manual tensioning • Allows surgeon to use both hands for tibial fixation • Tension grafts up to 20 lbs. Tendon Strippers • Closed-Ended stripper easily separates hamstring tendons from muscle attachments when grafts are detached from the distal tibia • Open-Ended stripper bluntly strips hamstring tendons from muscle attachments when grafts are left attached to the distal tibia acl/pcl instrumentation Bone-Tendon-Bone Instrument System • Complete with graft harvest, tunnel and fixation instrumentation • Accommodates either the Howell™ 65˚ Tibial Guide, Modular Guide or the Fanelli™ PCL/ACL Guide • Instrumentation for titanium TunneLoc® interference screws or LactoSorb® Gentle Threads™ interference screws ACL/PCL Disposables • Disposable guide wire kits that are unique to each fixation system • Bone-tendon-bone blade kits for various capital equipment saws Bone Mulch™ Screw • Only femoral tunnel fixation that allows visualization of graft passage • Cannulation allows compaction of bone into femoral tunnel around ACL graft • Bone graft fills voids, promoting rapid healing of ACL graft to tunnel • Strength: 1126 N(1) • Stiffness: 225 N/mm(1) • Titanium implant that has optimal strength properties and captures cortical bone • Surgical technique that has minimal steps with reliable and reproducible deployment • Device captures the cortical bone of the femur, preventing movement under cyclic loading • Strength: 1427 N(2) Gentle Threads™ Interference Screws Allograft Cross Pin • Non-cannulated for maximum strength • Allograft Cross Pin has a failure load of 889 N(2) EZLoc™ Femoral Fixation Device AXL™ Cross Pin • Made of titanium or LactoSorb® L15 resorbable copolymer • Simplified graft passage with the use of the graft pusher • Reliable implant placement by implanting over a rigid wire • U-guide aids in accurate transverse tunnel placement • Ti Strength: 1780 N(2) • L15 Strength: 1031 N(2) • Blunt thread design assists in protecting the graft • Driver design distributes torque evenly throughout the entire screw to help prevent the screw from breaking or stripping • Screws are compatible with 1.5mm Nitinol guide wires • Easy-out screw remover virtually eliminates the difficulty of removing screws • Round head and fully threaded designs both available KNEES ToggleLoc™ Femoral Fixation Device Bio-Core™ Interference Screw • Resorbable interference screw made of LactoSorb® L15 resorbable copolymer • Fenestrations allow screw contents to be in contact with tendon/tunnel wall • Ability to be filled with osteoconductive material to allow for bone growth • Screw insertion is no different than other interference screws • Nothing else like it on the market • Femoral fixation device that captures the cortical bone of the femur • Designed with a simple surgical technique with few steps and no need for a U-guide • Loop is made of polyethylene, designed for strength and stiffness • Packaged pre-loaded with MaxBraid™ PE passing suture on a unique card, allowing simple loading of the graft • Requires only simple instruments, a depth gauge and a 4.5mm drill bit ToggleLoc™ Femoral Fixation Device with ZipLoop™ Technology • ZipLoop™ Technology maximizes soft tissue graft-to-tunnel interface • One implant for varying tunnel lengths—eliminates the need for multiple sizes • Tension can be applied from femoral side after tibial fixation is achieved • Uniquely woven polyethylene construct is gentle to graft and is slippage resistant acl/pcl fixation TunneLoc™ Round Head Interference Screw • Round head reduces the possibility of graft damage during or after graft implantation • Standard 2.5mm and 3.5mm hex for easier insertion and removal • Cannulated for use with a guide wire • Less aggressive middle threads reduce the possibility of graft damage • Tapered tip for easier starts and straighter tracking TunneLoc™ Fully Threaded Interference Screw • Universal screw for either tibial or femoral applications • Designed to reduce the possibility of bone plug migration during placement • Cannulated for use with a guide wire • Standard 3.5mm hex for easy insertion and removal • Tapered tip for easier starts and straighter tracking Poly Suture Button • Solid fixation for either primary or auxiliary fixation in ACL or PCL reconstruction • Distal fixation allows circumferential healing of the ACL graft to the tunnel wall No-Profile Screw and Washer WasherLoc™ Tibial Fixation Device • Bi-cortical fixation with either cortical or cancellous screws • Countersunk to avoid hardware prominence and patient discomfort • Distal fixation allows circumferential healing of graft to the tunnel wall • Strength: 905 N(3) • Stiffness: 273 N/mm(3) • Designed to be the lowest profile screw and washer on the market • 14, 18 and 20mm washers maximize soft tissue fixation • Cruciate screwdriver reduces strippage that results from high torque used in screw insertion and removal • Tapping and self-tapping screws available in 30–60mm in 2mm increments CentraLoc™ Tibial Fixation Device • Made of LactoSorb® L15 resorbable copolymer • Smooth post increases tunnel-to-graft interface assisting circumferential healing • Insertion is as easy as an interference screw, but without the need for a guide wire or dilator • Strength: 1176 N(2) • Stiffness: 240 N/mm(2) Resorbable No-Profile Screw and Washer • LactoSorb® L15 resorbable copolymer with 80% strength in eight months(2) • Versatile soft tissue applications • Simple technique • Strength: 712N(2) KNEES Meniscus Screw Meniscus Staple • Countersunk implant will assist in preventing femoral condyle damage • Tapered implant can be removed for repositioning • Greater tactile feel than pushing or malleting the implant • Implant packaged pre-loaded on disposable driver • Two-pronged implant for optimal pullout and strength retention throughout the healing process • U-shape helps to prevent implant from migrating through the tear during insertion • No head to contact condylar surface • Small curved instrumentation provides access to all zones • Implant placement is more versatile due to the width of two pronged implant. • 11 and 13mm lengths MENISCUS REPAIR CARTILAGE REPAIR OCD Microfracture System • Pick designed to stimulate healing of osteochondral defects—safer than drilling • Instrumentation designed to access difficult regions of the intraarticular space for debridement LactoNail® Bone Fixation • Various lengths and diameters to meet surgeon’s preference • Compression head • Barbed shaft to maintain compression • Easy insertion • Instruments may be used during an open or arthroscopic procedure • Strength: 87 lbs.(2) CurvTek® Bone Tunneling System • Consistent tunnels regardless of bone quality • Creates a strong bone bridge for each suture tie down • Fast and easy to use Charlotte™ Shoulder System • Complements all open, mini-open and arthroscopic procedures • Time-saving instrumentation • Modular system Nordt™ Knot Tightener • Allows both pushing and tightening of knots • Statistically as secure as hand-tied knots(10) • Most secure arthroscopic knots compared to a single hole and cannulated doublediameter knot pushers(10) • Allows tying of any type or size of suture SHOULDERS SpeedPass™ Suture Retrievers BiPass™ Suture Punch • Dual purpose instrument that passes and retrieves suture simultaneously reducing O.R. time • Unique “trap door” captures suture—reducing suture management steps • Nitinol pusher maintains suture integrity • One hand operation for arthroscopic rotator cuff repair • Ergonomic, low profile design • Large tissue bite—up to 16mm for double row rotator cuff repair • Various tip curvatures for arthroscopic Bankart, SLAP and rotator cuff repairs • Sharp tip allows easy penetration through tissue • Simple thumb slide deployment system utilizing Nitinol loop for retrieving or passing any type of suture • Pigtail 70˚ curvature is ideal for reaching the low five o’clock position for anterior labral repair or capsular tissue plication SpeedPass™ Suture Lariat • Various tip curvatures for arthroscopic Bankart, SLAP and rotator cuff repairs • Sharp tip allows easy penetration through tissue • Accomplishes a simple shuttle step to pass suture through tissue • Passes suture outside the joint utilizing shuttle relay technique with Nitinol or monofilament SHOULDER SYSTEMS MaxBraid™ PE Suture • Made from 100% polyethylene • Unique braid which allows the suture to lie flat and improves knot security • Silky smooth feel is gentle on tissue and gloves Strength Comparison (lbs.) Ethibond™ Excell #24 Fiberwire™ Suture5 MaxBraid™ Suture2 Tensile 27.01 60.96 69.18 Knot 12.61 29.83 39.45 LactoScrew® Suture Anchor AutoKnot™ Pre-Tied Knot • Allows the ability to reposition if unsatisfied with initial position • Simple insertion technique— tap only • Pullout strength (5.5mm): 87 lbs.(2) • 2.8mm, 3.5mm, 5.5mm and 6.8mm sizes • LactoSorb® L15 copolymer resorbs in approximately two years(2) • Duncan Loop chosen for its great strength, efficiency, and gentleness to suture • MaxBraid™ Suture braided with Dyneema® Purity fiber • LactoSorb® L15 copolymer resorbs in approximately two years(2) • Available on 3.5mm, 5.5mm and 6.8mm LactoScrew® Suture Anchors Harpoon® Suture Anchor • Expanding wings for superior fixation • Stainless steel ALLthread™ Suture Anchor Ti-Screw Suture Anchor with EasySlide™ Surface Treatment • Easy sliding sutures • Allows the ability to reposition • Simple insertion technique • Pullout strength (5.0mm): 120 lbs.(2) • Available in titanium, LactoSorb® L15 copolymer and PEEK-Opitma® polymer • Fully threaded • Cortical bone purchase • Double-loaded, double eyelet • Titanium anchor is offered in a triple eyelet version SHOULDERS Cannulated ArthroRivet™ Tack • Eliminates knot tying and suture management problems • Strong tissue fixation • Easy tissue grasping • Small implant size allows for multiple implant placement • Cannulated to align tack with drill hole • Strength: 44 lbs.(2) Rotator Cuff Buttress • Reduces suture cutting through bone during bone tunnel repair • No special instruments required • Universal size fits left and right tuberosities • Resorbs in 9–15 months(2) SHOULDER SYSTEMS Hitch™ Suture Anchor • Available in PEEK-Optima® polymer and LactoSorb® L15 copolymer • Available in 2.4mm for labral repair • Offset suture loop eyelet • Loaded with #2 MaxBraid™ Suture • Small implant size allows for multiple implant placement MicroMax™ Suture Anchor • Easy deployment system • Mechanical fixation • Loaded with MaxBraid™ Suture • Material resorbs in approximately two years(2) • Small implant size allows for multiple implant placement SportMesh™ Soft Tissue Reinforcement • Soft tissue scaffold • Easy to cut and shape to soft tissue • Easy to handle • Controlled, intermediate resorption process • The degradation process causes a lack of an inflammatory response because the material is non-crystalline and has a low pH • High porosity which acts as a wick to soak and hold blood. Precision Series Hand Instruments • Ergonomically designed handle gives surgeons the strength, durability and “feel” they desire • Teflon bushing in handle reduces the possibility of metal-on-metal wear and allows for smoother instrument function • The solid stainless steel design allows the hand and instrument to move as one, providing more comfort • Can result in less hand fatigue during lengthy surgical procedures • Designed to be the strongest handle and tube configuration available in a hand instrument hand instruments • Tapered tube design creates increased stability and strength to both actuator and the tube • Precision made cutters provide smooth and clean cuts even with the most difficult tissue • Low-profile jaws for easier entry into tight joint space • Multiple styles and tip configuration allow access into all areas Absorb-O-Mat™ O.R. Floor Mat • Outstanding wicking, absorption and retention capabilities • Does not release fluids when stepped on • O.R. floor mat, prevents the mat from slipping, providing additional safety and peace of mind • Various sizes and shapes let you choose the best configuration suited to your application • One square foot absorbs one liter of fluid Fluid Management Five Gallon Disposable Container • Packaged collapsed, minimizes shelf space • Universal port fits most waste lines • Open/close valve to minimize spillage • Convenient carrying handle HAND INSTRUMENTS • Designed to quickly gel blood and body fluids • Guards against spills and leaks facilitating safer handling and trasport of potentially infectious fluids • 2 oz. gels up to 2,000 cc • Chlorine-free formula eliminates the risk of toxicity during incineration • Unlike competitive solidifiers, ArthroSorb™ Super Solidifier does not cause fluid expansion FLUID MANAGEMENT ArthroSorb™ Super Solidifier ReUnite® Small Screw System • Limited-torque compression head • Maximizes surgical options • Color-coded drill bits/taps • Drill guides for precise placement • Can be used with ReUnite® plates ReUnite® Large Screw System ReUnite® Orthopedic Plating System • Maximize surgical options • Geometric plates • Water activated heat packs for easy bending and forming • Able to be trimmed for desired shape • Precise pick-ups for handling • To be used with the ReUnite® Screw System • 3.5mm diameter fully threaded screws • 4.0mm diameter fully threaded screws • 5.0mm diameter fully and partially threaded screws • Cannulated or solid • Maximizes surgical options • Easy screw removal, if necessary ReUnite® Orthopedic Pin System • Diameters: 1.5mm x 3.2mm • Lengths: 20 – 70mm • Length-adjustable inserters • Combination depth/K-wire gauge and family of K-wires to aid in preparation of optimal hole for pin placement • Disposable kit available Weil-Carver™ Hammertoe System • Partially threaded for maximum stability • Partially barbed to help prevent pistoning • Completely internal to eliminate risk of pin tract infections • Patient-friendly— no external hardware Rattler™ Interference Screw • Designed for use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow and knee • Retains 80% of its strength at eight weeks while being fully resorbed in 9–15 months(2) • Provides lasting strength throughout the healing process while resorbing in a timely fashion(2) Propeller Head™ Screw System • Self-drilling • Self-tapping • Self-countersinking • Low-profile head • Titanium alloy — greater torque strength, MRI & CT compatible • Partial thread lengths • Cor-cellous threads for use in cortical and cancellous bone • Cannulated for precise placement • Minimal instrumentation simplifies procedure, reduces O.R. time SMALL BONE & JOINT small bone & joint PowerTek™ HR Digitial Video Camera • 3-chip all digital camera with programmable buttons on compact camera head • Unique software enhances depth perception for a natural color reproduction capital equipment PowerTek II Plus High Speed Shaver System ™ • Capable of speeds up to 12,000 RPM for efficient bone removal and meniscal cutting PowerPump® LT Arthroscopy Pump • Provides constant visualization by maintaining dilation monitored by two pressure sensors to provide consistent joint pressure • For use in a diagnostic environment • Can be used in addition to MRI or alone to determine the next plan of action for each patient • The InnerVue™ System is comprised of: InnerVue™ Scope Hand Piece • Diameter of 1.2mm (about the size of an 18 gauge needle) and requires one portal INNERVUE SYSTEM diagnostic scope CAPITAL EQUIPMENT • The system hardware, software and hand piece • A disposable scope • Reusable instrumentation (cannula, trocar, blunt obturator and cannula plug) • A procedural kit is also available that includes many sterile items such as tubing, skin prep, drapes (including the incise drape, stand drape, etc.), scalpel, 3-way valve, syringe, etc. B-One™ XR Bone Substitute • Animal studies jave demonstrated the material ban be 50% replaced with bone at six months2 • B-One™ XR Bone Substitute is a mixture of ceramic calcium sodium phosphate (CaNaPO4O) powder and sodium citrate dihydrate (Na3C6H5O72H2O) biomaterials CuffPatch™ Soft Tissue Reinforcement • Purified—to remove undesired proteins, cellular debris and lipids • Laminated—eight layers provide optimal fixation • Crosslinked to help strengthen device for rotator cuff repair • Hydrated implant for fast and easy implantation—no wait time • Non-refrigerated—the CuffPatch™ implant does not need to be refrigerated but should be stored at temperatures below 120˚ • The 6.5cm x 9cm implant can be trimmed to desired size without weakening or changing integrity of implant The Strength of Resorbable Fixation Introduction Surgeons are increasingly recognizing the benefits of resorbable technology as an internal fixation option for their patients. Elimination of future implant removal surgery, clearer radiographs and more physiological load sharing between the implants and the surrounding tissues have the potential to positively impact both the outcomes and economics of surgery. Recent advances in biomaterials science have produced new resorbable polymers. Coupled with the introduction of new implant configurations similar in form and function to those of traditional metal systems, resorbable internal fixation is a dominant treatment modality. Resorbable Fixation Dynamics The LactoSorb® copolymer is a unique chemical combination of L-lactic acid (82%) and glycolic acid (18%). This formulation provides a perfect balance of properties, i.e., strength retention/ loss timed to complement healing, complete mass loss in 9–15 months and enhanced biocompatibility during degradation, principally due to the lack of crystallinity. The ReUnite® system includes pins, screws, plates, sheets and mesh panels, providing the “building blocks” to suit a wide variety of clinical needs. Innovations such as cannulated resorbable screws and plates, sheets and mesh panels that can be heated, cut and shaped, enhance the versatility of the system. The LactoSorb® L15 copolymer is a unique chemical combination of L-lactic acid (85%) and glycolic acid (15%). This composition possesses the initial strength similar to that of LactoSorb.® In vitro studies show this material to hold about 70% of initial strength for over ten months. In addition, based on viscosity profile, the polymer is expected to fully degrade in just under 1.5 years. The material is thus suitable for applications where strength retention for over nine months is demanded.9 BIOMATERIALS Initially, 100% of the strength of the repair site is provided by the resorbable implants. When the implants lose all strength, then 100% of the fixation should be provided by the biological union. At intermediate times, the load is shared between the resorbable implants and the partially healed union. Ideally, the loss of strength of the resorbable fixation should mirror the increase in strength of the biological union over a six to eight week period so that substantial strength of repair exists through all phases of healing.6,7 References 1. To JT, Howell SM, Hull ML: “Contributions of femoral fixation methods to the stiffness of anterior cruciate ligament replacements at implantation. Journal of Arthroscopic and Related Surgery, 15:379–387, 1999. 2.Data on file at Biomet Sports Medicine. Bench test results are not necessarily indicative of clinical performance 3.Magen HE, Howell SM, Hull ML: “Structural properties of six tibial fixation methods for anterior cruciate ligament soft-tissue grafts.” American Journal of Sports Medicine, 27:35–43, 1999. 4.Data supplied by DSM Dyneema. 5.Testing performed by Arthrex, Oct. 2000. 6.An YH, et al.: Clinical Orthopedics, 355: 330–311; 1998. 7.Pietrzak WS, et al.: “Bioresorbable implants—practical considerations.” Bone, 19(1); 109S–119S. 8.Pietrzak WS, et al.: “Effect of stimulated intraoperative heating and shaping on mechanical properties of a bioabsorbable fracture plate material.” Applied Biomaterials, 38(1): 17–24; 1997. 9.Kumar M: “A novel engineered material: In vitro properties for 85L-Lactide 15 Glycolide.” Biomaterials Division, Biomet, Inc. 10. Milia M, Peindl R, Connor P; “Arthroscopic Knot Tying: The role of instrumentation in achieving knot security.” Arthroscopy, Vol. 21, Issue 1 pp. 69 – 76, January 2005. Dyneema® is a registered trademark of DSM Dyneema B.V. or an affiliate of Koninklijke DSM N.V. Fiberwire™ is a trademark of Arthrex. Ethibond™ is a trademark of Ethicon. Inc. LactoSorb® is a trademark of Biomet Manufacturing Corp. All others are trademarks of Biomet Sports Medicine, Inc. Should you have questions regarding the product line or would like to have a Sales Representative contact you, please call the Corporate Headquarters at 800.348.9500 ext. 1501 for information. Corporate Headquarters: Biomet Sports Medicine 56 East Bell Drive Warsaw, IN 46582 800.348.9500 Manufacturing Location: Biomet Sports Medicine 4861 East Airport Drive Ontario, CA 91761 800.535.8692 Capital Equipment Location: Biomet Sports Medicine 6704 Lockheed Drive Redding, CA 96002 This material is intended for the Biomet Sports Medicine Sales Force and surgeons only. It is not intended to be redistributed without the express written consent of Biomet Sports Medicine. P.O. Box 587, Warsaw, IN 46581-0587 • 800.348.9500 ext. 1501 • ©2005, 2006, 2007 Biomet Sports Medicine, Inc. All Rights Reserved web site: www.biometsportsmedicine.com Form No. Y-BMT-1046/013107/K