OptiLock Periarticular Plating System For Distal Femoral Fractures. Pre-Launch Surgical Technique

Transcription

1 OptiLock Periarticular Plating System For Distal Femoral Fractures Pre-Launch Surgical Technique

2 Contents Introduction... Page 1 Indications And Fracture Classification... Page 6 Design Features... Page 7 Surgical Technique... Page 8 Ordering Information... Page 17 Further Information... Page 21

3 Introduction The OptiLock Periarticular Plating System (OPPS) utilizes unique patent pending SphereLock technology. This advanced implant/instrumentation design allows for effective and efficient anatomic fixation of distal femoral fractures. The OptiLock Periarticular Plating System offers both left and right distal lateral femoral pre-contoured, titanium alloy plates for optimizing fixation of simple and complex condylar fractures of the femur. Lateral Plates The anatomically contoured distal lateral femoral plate is available in 3-hole increments from 3 to 18 holes, ranging from mm in length for right and left distal femurs. For easy recognition, the left distal lateral plates are colored light blue and the right plates are colored gold. Complete anatomic restoration is facilitated through precise anatomic contouring, multiple bone screw options, and proper plate positioning on the lateral aspect of the distal femur. 1

4 Introduction (Continued) Locking Bone Screws A unique, patent pending aspect of the OptiLock Periarticular Plating System is application of either locking or non-locking bone screws through any threaded hole of the plates. By design, the screw head for each diameter screw is seated virtually flush to the plate surface. This allows for maximum flexibility in choice of screw diameter with minimal hardware prominence, which minimizes potential for irritation or impingement of soft tissue. The 3.5mm locking bone screws range in lengths from 10mm 95mm mm in 2.0mm increments 20-40mm in 4.0mm increments The 5.0mm self-drilling locking bone screws are available in 14mm, 18mm, 26mm, 40mm and 55 85mm in 10mm increments. 14mm (Flat nose only) 18mm (Flat nose and self-drilling) 26mm 40mm in 10mm increments The 5.5mm self-drilling cannulated locking bone screws range in length from 25 95mm in 5.0mm increments for precise application over a 2.0mm x 25cm K-wire. The 5.5mm outer diameter size may be considered ideal for a metaphyseal application in the distal femur mm in 5.0mm increments The 4.5mm locking bone screws range in lengths from 14mm 95mm mm in 2.0mm increments 20-40mm in 4.0mm increments 40-95mm in 5.0mm increments 2

5 Non-Locking Bone Screws The 3.5mm non-locking bone screws range in lengths from 8.0mm 95mm. 5.5mm Non-locking 5.5mm Locking 8-60mm in 2.0mm increments 60 95mm in 5.0mm increments 5.0mm Locking, Self-Drilling The 4.5mm non-locking bone screws range in lengths from 14mm 95mm mm in 2.0mm increments 60-95mm in 5.0mm increments The 5.5mm self-drilling cannulated non-locking bone screws range in length from 40 95mm in 5.0mm increments for precise application over a 2.0mm x 25cm K-wire. 4.5mm Non-Locking 4.5mm Locking 3.5mm Locking 3.5mm Non-Locking With a wide variety of sizes of locking and non-locking bone screws and locking bone screw trajectories, the OptiLock Periarticular Plating System sets a new standard for internal fixation of distal femoral fractures, effectively meeting the discriminating preferences of surgeons to produce desired patient outcomes. 3

6 Introduction (Continued) Outer Diameter Drill Bit Size Suggested Application 5.5mm Self-Drilling, Cat. # 27555: 4.5mm Used in the condyles of the distal femur. Cannulated over a 2.0mm guide Cannulated Non-Locking Cat. # 27585: 5.5mm (Lag) wire. A 5.5mm drill bit allows for a lag technique to be used with the plate 5.5mm Self-Drilling, Cat. # 27550: 4.8mm Used in the condyles of the distal femur. Cannulated over a 2.0mm guide Cannulated Locking wire. Can be used in larger patients as truss load sharing screws for support of subchondral bone 5.0mm Self-drilling Locking Cat. # 27557: 4.3mm Used in the condyles of the distal femur or in diaphyseal bone for a locked, unicortical approach 5.0mm Self-drilling Locking, Cat. # 27557: 4.3mm For use through the distal femoral plate s threaded screw holes Flat Nose Used for periprosthetic fractures 4.5mm Non-locking Cat. # 27565: 3.2mm Used in cortical bone of the distal femur through any plate threaded bone screw hole for lagging fixation; may be applied in metaphysis or diaphysis of distal femur through any plate threaded bone screw hole for lagging fixation 4.5mm Locking Cat. # 27560: 3.8mm Primarily used in cortical bone. May be used in distal femoral metaphyseal bone in smaller patients 3.5mm Non-Locking Cat. # 27575: 2.5mm May be used for fragment capture, manipulation, and lagging Cat. # 27562: 3.5mm (Lag) Primarily used in proximal/distal tibial plate applications 3.5mm Locking Cat. # 27570: 2.7mm Used in cortical bone 2.7mm Non-Locking Cat. # 27580: 2.0mm Primarily used in distal tibial plate applications Used for lagging fragments 2.7mm Locking Cat. # 27580: 2.0mm Primarily used in distal tibial plate applications 2.0mm Non-Locking Cat. # 27582: 1.5mm Apply through K-wire holes for additional lagging fixation While Biomet suggests specific bone screw sizes for specific applications, the surgeon is the ultimate decision maker for applying appropriate bone screw sizes and types based on clinical need. 4

7 2.0mm Non-Lock; thread pitch is.020mm 5.5mm Cannulated Non-Lock; thread pitch is 1.75mm 5.5mm Cannulated Lock; thread pitch is 1.25mm 5.0mm Self-Drilling Lock; thread pitch is 1.0mm 5.0mm Self-Drilling Lock, Flat Nose; thread pitch is 1.0mm 4.5mm Non- Lock; thread pitch is 1.75mm 4.5mm Lock; thread pitch is.080mm 3.5mm Non- Lock; thread pitch is 1.25mm 3.5mm Lock; thread pitch is.080mm 2.7mm Non- Lock; thread pitch is 1.0mm 2.7mm Lock; thread pitch is 1.0mm 5

8 Indications And Fracture Classification Indications For Use Split fractures of the femoral condyle Split fractures with shaft involvement Distal shaft fractures Supracondylar Femoral Fractures Extra Articular Unicondylar Supracondylar Femoral Fractures Bicondylar Hoffa Fragment Distal Femoral Shaft Fracture 6

9 Design Features Providing Optimized Solutions For A Variety Of Distal Femoral Fractures Lateral plates are composed of titanium alloy and offer strength and anatomic contouring for application to the distal femur. Color-coded implants and instruments make the OptiLock Periarticular Plating System easy to use, which enable intraoperative efficiencies. Patent Pending SphereLock Technology Staggered plate holes promote increased stability and greater protection against screw pullout. Locking bone screw trajectories produce rafting support of subchondral bone with combined Truss load sharing bone screws to protect from varus collapse Double radius of curvature r 1 = 2.41m and at hole #11, r 2 =.76m incorporated into 15 and 18-hole plate designs to aid in proper anatomic restoration Wide variety of bone screw sizes (2.0, 2.7, 3.5, 4.5, 5.0 and 5.5mm) Locking and non-locking bone screw types Patent pending slotted carbon figer jig may be used independent of its head for an accurate, intraoperatively efficient minimal invasive approach to distal femoral plate application. 7

10 Surgical Technique STEP 1: Patient Positioning Standard Approach Minimal invasive Approach: Lateral Plate The patient should be placed in the supine position on a radiolucent table. A wedge pillow or prop of the surgeon s choice will suffice to raise the affected leg above the contralateral side, providing a position for a good lateral x-ray. Confirm that unobstructed anterior-posterior and lateral radiographic images are obtainable. Prep and drape in the usual orthopedic fashion with the appropriate lower extremity exposed. If temporary external fixation was not previously applied, then use manual traction or skeletal distraction (ligamentotaxis) to obtain gross metaphyseal alignment. Full Jig Application: A minimal invasive approach is made possible with provision of a radiolucent targeting jig. The head of the jig seats and locks to the metaphyseal head of the plate with soft tissue and drill guides, which can be affixed to both the head and tail of the jig for optimized and reproducible bone screw targeting accuracy. NOTE: Make sure all connections are all hand tight with screwdriver after initial alignment has been obtained. C B A F E D H G Truss Locking Bone Screw Holes 8

11 I. After removing cap from the lock wire guide jig (Cat. # 26928), thread the shaft into screw hole D, which has three dimples surrounding it. II. Insert lock wire guide jig into the corresponding jig head hole identified in he middle of the jig head pins (hole D). III. Thread cap of lock wire guide jig back on to the shaft and tighten down using the butt end of the drill guide s long handle (Cat. # 26935). IV. To complete the assembly, align the jig tail pins with the dimples on the jig head. Jig head Pins Jig tail Pins 9

12 Surgical Technique (Continued) STEP 2: Skin Incision Standard Approach A curved or straight anterolateral incision is recommended. The initial skin incision is made mid-line at the knee, lateral parapatellar region and then perform a lateral parapatellar arthrotomy. Coagulation of any bleeders may be necessary. Proximal Jig Head Application: A less invasive approach can be performed for those cases amenable to this technique. A short, oblique incision is made just slightly distal to the lateral condyle and extended proximally 8cm. Exposure of the lateral surface of the distal femur is performed with a periosteal elevator. The knee joint can be exposed, if needed, via a minimal dissection and sub-meniscal arthrotomy where needed. The proximal targeting is minimally invasive with the use of the OptiLock jig in a periosteal sparing approach. The distal aspect of the jig locks to the metaphyseal head of the plate. With this setup preoperatively and under fluoroscopic image guidance, the outrigger locking guide can be percutaneously inserted and locked with minimal soft tissue dissection for proximal interlocking. STEP 3: Standard Approach Reduction And External Fixation Prior to reducing the articular surface, external fixation may be applied to help facilitate visualization and reduction of the joint. In the case of open fractures, external fixation - such as a Pin-to-Bar fixator may already have been applied to allow for treatment of soft tissue trauma. Low profiling jig head allows surgeons to easily identify locked screw trajectories for efficient locked drill guide application to plate. NOTE: The low profile jig head is designed to be slightly loose, even after the tightening the constrained bolt to the plate. This does not adversely affect application. 10

13 Articular Reduction STEP 4: Preliminary Plate Position In displaced intraarticular fractures, the priority of reducing the articular surface must occur before periarticular plate application. This may be accomplished by temporarily securing articular fragments with reduction forceps and/or by applying K-wires (2.0mm x 250mm) Cat. # threaded or Cat. # Non-threaded. Determine the appropriate length of the distal femoral plate via x-ray measurement or by inserting the plate up the lateral side of the femur, using it as a template and checking length radiographically. Provisionally apply a K-wire through the distal hole in the center of the head of the plate, parallel to the knee joint. Once temporarily reduced, 3.5mm, 4.5mm or 5.5mm non-locking bone screws may be utilized for compression independently outside of the plate as needed or be utilized within the metaphyseal head of the periarticular plate. These lag screws may be inserted through any of the threaded plate holes. Regardless of the approach, the placement of a lag screw should be based upon a preoperative plan, so that locking bone screw trajectories are avoided. Standard Approach Reduction Reduce the fracture using manual traction or skeletal distraction (ligamentotaxis) to obtain gross metaphyseal alignment. For holding reduction, apply K-wires and clamp and verify under fluoroscopic imaging. Standard Approach Reduction Holding NOTE: By using the jig head attached to the plate, this will give you a true trajectory across the condyle for the K-wire. Use the Z-1 hole. Once in good position, prepare to apply a lag screw (3.5mm non-locking screw recommended) through the very distal posterior aspect of the distal femur and verify with fluoroscopic imaging. Be certain to verify that the position does not encroach on the intracondylar notch. Over-drill the near cortex to the fracture site, then use the appropriate core diameter calibrated drill bit to drill through the opposite side of the fracture to the contralateral cortex. Apply the selected non-locking bone screw for intrafragmentary fixation. At this time, a second reduction may be applied via ligamentotaxis and provisional external fixation applied. 11

14 Surgical Technique (Continued) STEP 5: Plate Position Using specific anatomic benchmarks, mount the plate on the intact or reconstructed distal femur. Do not yet attempt to reduce the distal portion of the plate to the femoral diaphysis. If this is done, the trajectories for the proximal screws may be altered. On the lateral C-arm position (posterior aspect of the medial and lateral femoral condyles overlapping), the proper position for the plate is such that the anterior border of the plate parallels the anterior border of the femoral diaphysis. The proximal/distal location of the plate is such that the posterior proximal hole should be at the level of the lateral joint line. Based on the preoperative plan, a free hand technique can be used by taking the selected lateral distal femoral plate (usual length is 3-4 cortical screws distal to the fracture) and affix the locking drill guides into the five most proximal threaded plate holes and the truss hole. When this is done prior to insertion, the threading of the sleeves is much easier without soft tissue interference. Under power and fluoroscopic image guidance, insert a 2.0mm x 250mm K-wire through both proximal holes making sure on the lateral view the plate is aligned appropriately. Once the proximal aspect of the plate is secured, secure the distal aspect of the plate to prevent rotation. Because the OptiLock Periarticular Plating System is a multiplanar locked plate, the positioning is paramount prior to locking. Prior to proceeding, confirm the placement of the plate head to the metaphysis. The following should be confirmed under fluoroscopy. K-wires are inserted in the subchondral bone and are confirmed extra articular in planar fluoroscopy and clinical inspection (sub-meniscal arthrotomy) The plate is positioned correctly on the lateral femur by using bi-planar fluoroscopy The plate shaft is aligned with the diaphysis according to AP and lateral radiographs, which ultimately determines final flexion/extension reduction The plate is correctly positioned on the femur and is affixed to the bone using K-wires distally and proximally to keep alignment during bone screw insertion 12

15 STEP 6: Reducing Proximal Shaft To Femur STEP 7: Insert Distal Bone Screws Reduce the distal femoral component to the diaphysis by temporarily securing the plate to the femoral shaft with bone forceps. At this point, rotation of the extremity must be confirmed via clinical examination. Once acceptable rotation has been achieved, the plate must be maneuvered for compressing or distracting to the acceptable anatomic length. For complex intraarticular fracture patterns, it may not be desired or possible to anatomically reduce the fracture. Additionally, the OptiLock temporary fixation device may be used to reduce fragments. I. The plate position must be secured on the lateral aspect of the distal femur with the K-wires, prior to inserting the first bone screw. II. Advance the K-wire until it reaches the medial cortex when inserting convergent bone screws. III. If the plate inadvertently shifts from the desired position during bone screw insertion, then all guide wires must be removed and reinserted using the locking drill guides. This countermeasure enables the bone screw to easily lock into the plate threaded screw hole. Care must be taken to ensure that the distal bone screws are out of the joint. Visual inspection of multi/planar fluoroscopy is performed to ensure that locked bone screws do not angle toward or penetrate the joint. Multi-angular locking trajectories in the OptiLock distal femoral periarticular plate, offers a unique element of stability to the fracture construct. The effective pull out forces are well countered by these multi-planar locked screws The locking threaded screw holes in the central proximal aspect of the periarticular plate generate converging bone screw trajectories for improved pullout strength. When using locking bone screws longer than 60mm, it is possible that the converging bone screws may meet in the subchondral bone. Therefore, accurate determination of bone screw length is crucial. This is accomplished by sliding the depth gauge over the K-wire that extends beyond the locked drill guide. All locking bone screws should be tightened for a secure fit into the periarticular plate. A power drill combined with the torque-limiting device provided in the set may also be utilized to definitively set the screws in the plate. 13

16 Surgical Technique (Continued) STEP 8: Insert 4.5mm Bi-cortical Or 5.0mm Uni-Cortical Locking Bone Screws According to clinical requirement or to surgeon preference, 4.5mm or 5.5mm locking bone screws may be inserted into the distal threaded holes along the plate shaft. After drilling, bone screw length may be measured off of the drill bit, with the assistance of fluoroscopy and/or depth gauge. The 5.0mm self-drilling, locking bone screws may be used in diaphyseal bone, if desired or required. No drilling prior to insertion is necessary. An irrigation method requiring a Trocar, Cat. # 26929, a Soft Tissue Sleeve, Cat. # 26910, and an irrigation Cooling Cap, Cat. # Then an IV extension tubing with the end cut off and a 60cc syringe can be attached to the Cooling Cap. This can be used to irrigate the bone surface while drilling the 5.0mm screws to prevent overheating. 14

17 STEP 9: Insert Truss Locking Bone Screws Affix desired locking drill guide to the two oblique angled threaded plate holes (J&K) and drill with the corresponding 4.0mm drill bit. Measure the appropriate bone screw length under fluoroscopic image guidance, directly off of the calibrated drill bit and/or depth gauge. The purpose of the Truss bone screw is: 1. To aid in load sharing on the medial side of the metaphysis; 2. To protect from varus collapse; and 3. To resist pull out of the plate bone construct. Optional: Distal Femoral Jig Tail Only Application Retro Targeting The OptiLock Periarticular Plating System offers a retro targeting approach, whereby the carbon fiber jig tail can be used independent of the jig head. This allows for unobstructed visualization of the distal femur with freehand locking and percutaneous retro jig use for bone screw locking. Once a stab incision is made, at least two drill guides and two soft tissue guides are locked into the plate. The carbon fiber jig tail is then attached and locked into place by the soft tissue guides. Proceed with drilling and insertion of screws. Alternatively, the 4.5mm, 5.0mm, or 5.5mm locking bone screws may be used as Truss bone screws. 15

18 Surgical Technique (Continued) STEP 10: Standard Approach Fluoroscopic Image Confirmation Confirm fixation under fluoroscopic image guidance in both the AP and lateral planes. Close incision. Post Op 2.5 Months Post Op 16

19 Ordering Information OPPS Complete Set Catalog Numbers Catalog # Description Qty A/B Instrument/Screw Tray-Fully Packed A/B Distal Femoral Tray-Fully Packed 1 Total Sets Required For Distal Femoral Plate Applications 2 OPPS Instruments Catalog # Description Qty Instrument/Screw Tray Distal Femoral Tray Soft Tissue Guide mm Lock Drill Guide Long mm Lock Drill Guide Long mm Lock Drill Guide Long mm Wire Sleeve Long Lock mm Drill Guide Long mm Drill Guide Long mm Drill Guide Long mm Drill Guide Long mm Drill Guide Long mm Drill Guide Long mm Drill Guide Long Lock Wire Guide Jig Trocar Depth Gage (10mm To 110mm Range) Drill Guide Long Handle mm Wire Guide Non Lock Wire Depth Gage Long Cooling Cap /2.0mm Drill Guide AO Torque Limiting Coupler TF Sleeve mm Hex Driver Shaft AO mm Hex Driver Shaft AO Cannulated Tap 4.5mm Lock Screw Tap 4.5mm Non-Lock Screw Tap 3.5mm Lock Screw Tap 3.5mm Non-Lock Screw Fixed AO Handle Ratcheting AO Handle AO Driver For 2.0mm Screw AO Drill Adaptor Femoral Plate Left LD Jig Head Femoral Plate Left LD Jig Tail Femoral Plate Left LP Jig? Femoral Plate Right LD Jig Head Femoral Plate Right LD Jig Tail 1 Total Instrumentation 71 OPPS Distal Femoral Plates Catalog # Description Qty Left, Lateral Distal Femur 3H-122mm Left, Lateral Distal Femur 6H-174mm Left, Lateral Distal Femur 9H-227mm Left, Lateral Distal Femur 12H-281mm Left, Lateral Distal Femur 15H-333mm Left, Lateral Distal Femur 18H-386mm Femoral Plate Right LP Jig? Right, Lateral Distal Femur 3H-122mm Right, Lateral Distal Femur 6H-174mm Right, Lateral Distal Femur 9H-227mm Right, Lateral Distal Femur 12H-281mm Right, Lateral Distal Femur 15H-333mm Right, Lateral Distal Femur 18H-386mm 2 Total Plates 24 17

20 Ordering Information (Continued) OPPS Bone Screws Catalog # Description Qty mm x 10mm Non-Locking Screws mm x 12mm Non-Locking Screws mm x 14mm Non-Locking Screws mm x 16mm Non-Locking Screws mm x 18mm Non-Locking Screws mm x 20mm Non-Locking Screws mm x 22mm Non-Locking Screws mm x 24mm Non-Locking Screws mm x 26mm Non-Locking Screws mm x 28mm Non-Locking Screws mm x 30mm Non-Locking Screws mm x 32mm Non-Locking Screws mm x 34mm Non-Locking Screws mm x 36mm Non-Locking Screws mm x 38mm Non-Locking Screws 3 Catalog # Description Qty mm x 10mm Locking Screws mm x 12mm Locking Screws mm x 14mm Locking Screws mm x 16mm Locking Screws mm x 18mm Locking Screws mm x 20mm Locking Screws mm x 24mm Locking Screws mm x 28mm Locking Screws mm x 32mm Locking Screws mm x 36mm Locking Screws mm x 40mm Locking Screws mm x 45mm Locking Screws mm x 50mm Locking Screws mm x 55mm Locking Screws mm x 60mm Locking Screws mm x 65mm Locking Screws mm x 70mm Locking Screws mm x 75mm Locking Screws mm x 80mm Locking Screws mm x 85mm Locking Screws mm x 90mm Locking Screws mm x 95mm Locking Screws 3 Catalog # Description Qty mm x 8mm Non-Locking Screws mm x 10mm Non-Locking Screws mm x 12mm Non-Locking Screws mm x 14mm Non-Locking Screws mm x 16mm Non-Locking Screws mm x 18mm Non-Locking Screws mm x 20mm Non-Locking Screws mm x 22mm Non-Locking Screws mm x 24mm Non-Locking Screws mm x 26mm Non-Locking Screws mm x 28mm Non-Locking Screws mm x 30mm Non-Locking Screws mm x 32mm Non-Locking Screws mm x 34mm Non-Locking Screws mm x 36mm Non-Locking Screws mm x 38mm Non-Locking Screws mm x 40mm Non-Locking Screws mm x 42mm Non-Locking Screws mm x 44mm Non-Locking Screws mm x 46mm Non-Locking Screws mm x 48mm Non-Locking Screws mm x 50mm Non-Locking Screws mm x 52mm Non-Locking Screws mm x 54mm Non-Locking Screws 3 18

21 Catalog # Description Qty mm x 56mm Non-Locking Screws mm x 58mm Non-Locking Screws mm x 60mm Non-Locking Screws mm x 65mm Non-Locking Screws mm x 70mm Non-Locking Screws mm x 75mm Non-Locking Screws mm x 80mm Non-Locking Screws mm x 85mm Non-Locking Screws mm x 90mm Non-Locking Screws mm x 95mm Non-Locking Screws 3 Catalog # Description Qty mm x 14mm Locking Screws mm x 16mm Locking Screws mm x 18mm Locking Screws mm x 20mm Locking Screws mm x 24mm Locking Screws mm x 28mm Locking Screws mm x 32mm Locking Screws mm x 36mm Locking Screws mm x 40mm Locking Screws mm x 45mm Locking Screws mm x 50mm Locking Screws mm x 55mm Locking Screws mm x 60mm Locking Screws mm x 65mm Locking Screws mm x 70mm Locking Screws mm x 75mm Locking Screws mm x 80mm Locking Screws mm x 85mm Locking Screws mm x 90mm Locking Screws mm x 95mm Locking Screws 2 Catalog # Description Qty mm x 14mm Non-Locking Screws mm x 16mm Non-Locking Screws mm x 18mm Non-Locking Screws mm x 20mm Non-Locking Screws mm x 22mm Non-Locking Screws mm x 24mm Non-Locking Screws mm x 26mm Non-Locking Screws mm x 28mm Non-Locking Screws mm x 30mm Non-Locking Screws mm x 32mm Non-Locking Screws mm x 34mm Non-Locking Screws mm x 36mm Non-Locking Screws mm x 38mm Non-Locking Screws mm x 40mm Non-Locking Screws mm x 42mm Non-Locking Screws mm x 44mm Non-Locking Screws mm x 46mm Non-Locking Screws mm x 48mm Non-Locking Screws mm x 50mm Non-Locking Screws mm x 52mm Non-Locking Screws mm x 54mm Non-Locking Screws mm x 56mm Non-Locking Screws mm x 58mm Non-Locking Screws mm x 60mm Non-Locking Screws mm x 65mm Non-Locking Screws mm x 70mm Non-Locking Screws mm x 75mm Non-Locking Screws mm x 80mm Non-Locking Screws mm x 85mm Non-Locking Screws mm x 90mm Non-Locking Screws mm x 95mm Non-Locking Screws 3 19

22 Ordering Information (Continued) Catalog # Description Qty mm x 14mm SD Locking Screw, Flat Nose mm x 18mm SD Locking Screw, Flat Nose mm x 18mm SD Locking Screw mm x 26mm SD Locking Screw mm x 40mm SD Locking Screw mm x 55mm SD Locking Screw mm x 65mm SD Locking Screw mm x 75mm SD Locking Screw mm x 85mm SD Locking Screw 2 Catalog # Description Qty mm x 60mm Cannulated Lag Screw mm x 65mm Cannulated Lag Screw mm x 70mm Cannulated Lag Screw mm x 75mm Cannulated Lag Screw mm x 80mm Cannulated Lag Screw mm x 85mm Cannulated Lag Screw mm x 90mm Cannulated Lag Screw mm x 95mm Cannulated Lag Screw 2 Total Bone Screws 547 Catalog # Description Qty mm x 25mm Locking Screws mm x 30mm Locking Screws mm x 35mm Locking Screws mm x 40mm Locking Screws mm x 45mm Locking Screws mm x 50mm Locking Screws mm x 55mm Locking Screws mm x 60mm Locking Screws mm x 65mm Locking Screws mm x 70mm Locking Screws mm x 75mm Locking Screws mm x 80mm Locking Screws mm x 85mm Locking Screws mm x 90mm Locking Screws mm x 95mm Locking Screws 3 OPPS Disposable Instruments Catalog # Description Qty Unicortical TF Shaft 3.5mm Bicortical TF Shaft 3.5mm mm Cannulated Drill Bit AO (5.5 Lock) mm Drill Bit AO (5.5 Non- Lock) mm Drill Bit AO (5.0 Lock Self-Drilling) mm Drill Bit AO (4.5 Lock) mm Drill Bit AO (3.5 Non-Lock) mm Drill Bit AO (4.5 Non-Lock) mm Drill Bit AO (3.5 Lock) mm Drill Bit AO (3.5 Non-Lock) mm Drill Bit AO (2.0 Non-Lock) mm Cannulated Drill Bit AO (5.5 Lag) mm x 250mm Threaded Guide Wire, 5 Single mm x 250mm Non-Threaded Guide Wire, 5 Single Total Disposables 36 20

23 Further Information Biomet Trauma, as the manufacturer of this device, and their surgical consultants do not recommend this or any other surgical technique for use on a specific patient. The surgeon who performs any implant procedure is responsible for determining and utilizing the appropriate techniques for implanting the device in each individual patient. Biomet and their surgical consultants are not responsible for selection of the appropriate surgical technique to be utilized for an individual patient. For further information, please contact the Customer Service Department at: Biomet Trauma 100 Interpace Parkway Parsippany, NJ (973) (800)

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28 100 Interpace Parkway Parsippany, NJ Unless otherwise indicated, denotes a trademark, and denotes a registered trademark, of one of the following companies: Biomet Manufacturing Corp.; Electro-Biology, Inc.; EBI, L.P.; Biolectron, Inc.; Interpore Cross International, Inc., Cross Medical Products, Inc.; or Interpore Orthopaedics, Inc. Rx Only. Copyright 2007 Biomet, Inc. All rights reserved. P/N L 07/07