Tibial Opening Wedge Osteotomy System with Titanium Plates and Screws and OSferion B-TCP Osteotomy Wedge. Surgical Technique

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1 Tibial Opening Wedge Osteotomy System with Titanium Plates and Screws and OSferion B-TCP Osteotomy Wedge Surgical Technique Opening Wedge Osteotomy

2 Tibial Opening Wedge Osteotomy System w/titanium Plates and Screws 2 After reflecting back the superficial portion of the medial collateral ligament, the Cutting Guide for HTO is positioned at the medial tibia above the level of the tibial tubercle. Two Osteotomy Guide Pins are drilled through the guide to within 1 cm of the lateral cortex (angled towards the fibular head). An oscillating saw is positioned against the inferior surface of the guide to cut the tibial cortex medially, anteriorly and posteriorly. 1 Using the full-length, standing A/P radiograph, a line is drawn from the center of the femoral head to the center of the tibial-talar joint. This demonstrates the patient s mechanical axis. Another line is drawn from the center of the femoral head to a point midway* in the lateral knee joint. A final line is drawn from the center of the tibial-talar joint to the same point in the lateral knee joint. The angle formed by the intersection of these two lines determines the degree of correction required to return the patient s mechanical axis to the point of intersection on the lateral side. Prior to final fixation, the alignment will be verified by external examination and fluoroscopy. * This point is located at 62.5% of the width of the proximal tibia (i.e., 80 mm [width of proximal tibia] x.625 = 50 mm) 3 A single blade from the Osteotome Jack may be used to complete the osteotomy. The breakaway guide pins are left in place with the osteotome used inferiorly. Fluoroscopic confirmation should be checked repeatedly throughout the cutting process.

3 4 5 Insert both blades of the Osteotome Jack in the bone cut aligning both blades to each other. Using the 3.5 mm hex screwdriver, turn the screw slowly, opening the Osteotome Jack to the desired correction (the Wedge Trial for HTO may be used to estimate the correction), being sure to maintain the lateral tibial cortex hinge. Insert the Wedge Trial into the osteotomy (inset) to check the alignment of the extremity to verify the degree of correction. Insert the plate into the osteotomy with the Application Bar for HTO Plates. Load the extremity to close the osteotomy onto the tooth of the plate, ensuring optimum bone-to-tooth contact. a 6 Insert the Locking Guide into one of the proximal plate screw holes, making sure the guide teeth seat fully into the bushing. Align the guide's laser line with the slot of the washer. Insert the Drill Guide into the Locking Guide and drill a hole to the appropriate screw depth (screw length is determined by visualizing the laser marks on the drill as it exits the drill guide (a)). 7 Screw a 6.5 mm diameter cancellous screw into bone. When the first laser ring of the driver reaches the locking guide, align the long driver laser line to the long laser line of the locking guide. This ensures the screw will start correctly into the bushing. Finish screw insertion and repeat for all screw holes using 6.5 mm screws proximally and 4.5 mm cortical screws distally.

4 Surgical Technique 8 9 If one of the screw washers is slightly proud from the bone, unscrew the screw one-half turn (using the Locking Guide to stabilize the bushing). Turn the guide (while the screw is stabilized with the driver) clockwise to rotate the bushing on the screw head and position the plate flush to the bone surface. Retighten the screw into the bushing. Note: The laser mark on the plate designates this as a sloped plate. Plate positioning may be altered to offset inherent ligamentous instabilities. In ACL deficiencies, avoid increasing tibial slope. In PCL deficiencies, increase the tibial slope. (Position the tall part of the plate tooth posteriorly in the osteotomy to reduce posterior slope.) Concomitant HTO and ACL Procedure 10 Mark the osteotomy line at the level of the tibial tubercle. Prepare the bone tunnels by drilling the tibial tunnel slightly more proximal than a standard tunnel using the Constant Tibial Guide (52.5 ), just lateral to the anterior edge of the MCL. 11 After the osteotomy is completed, use the Osteotome Jack to gently open the bone to the desired degree of correction. Place the osteotomy plate as posterior to the bone tunnel as possible and fix it with screws. The osteotomy may be filled with autograft, allograft or OSferion bone substitute. The ACL reconstruction can now be completed.

5 Opening Wedge Osteotomy System Set (AR-13305S) includes: Osteotomy Wedge Osteotome Handle Osteotome Blades, 10 mm Osteotome Blades, 25 mm Osteotome Blades, 35 mm Parallel Guide Sleeve Body Parallel Guide Sleeve, qty. 2 Osteotomy Guide Assembly Osteotomy Cutting Guide Osteotomy Cutting Guide Pin Alignment Rod Femoral Osteotomy Retractor Radiolucent Retractor Universal Handle Extractor Cutting Guide for HTO Bone Graft Tamp Application Bar for HTO Plates Drill Guide for HTO Drill Guide for HTO Titanium Plates Bending Irons for HTO Plates, qty. 2 Depth Device for Osteotome Jack Osteotome Jack, 35 mm Osteotome Jack w/screwdriver, 35 mm Wedge Trial for HTO A/P Sloped Osteotomy Wedge Trial, large A/P Sloped Osteotomy Wedge Trial, small Screwdriver, 3.5 mm hex Screwdriver, 90, 3.5 mm hex Locking Guide for HTO Titanium Plates Depth Device, large Opening Wedge Osteotomy System Instrumentation Case Storage Case for HTO Plates Accessories: Patellar Tendon Retractor Medial Retractor for HTO Osteotomy Guide Pins, 2.4 mm, qty. 6 ( breakaway ) Osteotomy Guide Pins, 3 mm, qty. 6 Drill for HTO Titanium Screws, qty. 6 Osteotome Jack, 25 mm Bone Graft Substitute: OSferion Osteotomy Wedge, 7 mm x 30 mm OSferion Osteotomy Wedge, 10 mm x 30 mm OSferion Osteotomy Wedge, 12 mm x 35 mm OSferion Osteotomy Wedge, 15 mm x 35 mm AR AR AR AR AR AR AR AR AR AR AR AR AR AR AR AR AR AR AR AR AR-13323G AR AR S AR AR-13325L AR-13325S AR AR AR AR-4167 AR AR-13307P AR AR AR AR AR AR AR AR AR AR Titanium Plates: Tibial A/P Sloped Osteotomy Plate, 5 mm Tibial A/P Sloped Osteotomy Plate, 7.5 mm Tibial A/P Sloped Osteotomy Plate, 9 mm Tibial A/P Sloped Osteotomy Plate, 10 mm Tibial A/P Sloped Osteotomy Plate, 11 mm Tibial A/P Sloped Osteotomy Plate, 12.5 mm Tibial A/P Sloped Osteotomy Plate, 15 mm Tibial A/P Sloped Osteotomy Plate, 17.5 mm Tibial Opening Wedge Osteotomy Plate, 3 mm Tibial Opening Wedge Osteotomy Plate, 5 mm Tibial Opening Wedge Osteotomy Plate, 7.5 mm Tibial Opening Wedge Osteotomy Plate, 9 mm Tibial Opening Wedge Osteotomy Plate, 10 mm Tibial Opening Wedge Osteotomy Plate, 11 mm Tibial Opening Wedge Osteotomy Plate, 12.5 mm Tibial Opening Wedge Osteotomy Plate, 15 mm Tibial Opening Wedge Osteotomy Plate, 17.5 mm AR-13200ST-05.0 AR-13200ST-07.5 AR-13200ST-09.0 AR-13200ST-10.0 AR-13200ST-11.0 AR-13200ST-12.5 AR-13200ST-15.0 AR-13200ST-17.5 AR-13200T-03.0 AR-13200T-05.0 AR-13200T-07.5 AR-13200T-09.0 AR-13200T-10.0 AR-13200T-11.0 AR-13200T-12.5 AR-13200T-15.0 AR-13200T-17.5 Titanium Screws: HTO Plate Screw, 4.5 mm x 34 mm, cortical HTO Plate Screw, 4.5 mm x 36 mm, cortical HTO Plate Screw, 4.5 mm x 38 mm, cortical HTO Plate Screw, 4.5 mm x 40 mm, cortical HTO Plate Screw, 4.5 mm x 42 mm, cortical HTO Plate Screw, 4.5 mm x 44 mm, cortical HTO Plate Screw, 4.5 mm x 46 mm, cortical HTO Plate Screw, 4.5 mm x 48 mm, cortical HTO Plate Screw, 4.5 mm x 50 mm, cortical HTO Plate Screw, 4.5 mm x 52 mm, cortical HTO Plate Screw, 4.5 mm x 54 mm, cortical HTO Plate Screw, 4.5 mm x 56 mm, cortical HTO Plate Screw, 4.5 mm x 58 mm, cortical HTO Plate Screw, 4.5 mm x 60 mm, cortical HTO Plate Screw, 6.5 mm x 35 mm, cancellous HTO Plate Screw, 6.5 mm x 40 mm, cancellous HTO Plate Screw, 6.5 mm x 45 mm, cancellous HTO Plate Screw, 6.5 mm x 50 mm, cancellous HTO Plate Screw, 6.5 mm x 55 mm, cancellous HTO Plate Screw, 6.5 mm x 60 mm, cancellous HTO Plate Screw, 6.5 mm x 65 mm, cancellous HTO Plate Screw, 6.5 mm x 70 mm, cancellous AR-13334T AR-13336T AR-13338T AR-13340T AR-13342T AR-13344T AR-13346T AR-13348T AR-13350T AR-13352T AR-13354T AR-13356T AR-13358T AR-13360T AR-13235T AR-13240T AR-13245T AR-13250T AR-13255T AR-13260T AR-13265T AR-13270T

6 Arthrex, Inc Creekside Boulevard, Naples, Florida USA Tel: Fax: Web site: Arthrex GmbH Liebigstrasse 13, Karlsfeld/Munich Germany Tel: Fax: Arthrex Iberoamérica Howard Hughes Tower, 6701 Center Drive West, Suite 550, Los Angeles, California USA Tel: Fax: Arthrex S.A.S. 5 Avenue Pierre et Marie Curie, Lezennes France Tel: Fax: Arthrex Canada Lasswell Medical Co., Ltd., 405 Industrial Drive, Unit 21, Milton, Ontario Canada L9T 5B1 Tel: Fax: Toll-Free: Arthrex GesmbH Triesterstrasse 10/ Wiener Neudorf Austria Tel: Fax: Arthrex BvbA Technologiepark Satenrozen, Satenrozen 1a, 2550 Kontich Belgium Tel: Fax: Arthrex Ltd. Unit 16, President Buildings, Savile Street East, Sheffield S4 7UQ England Tel: Fax: Arthrex Hellas - Medical Instruments SA 103, Ethnikis Antistasseos str., N. Psichico Athens Greece Tel: Fax: Arthrex Sverige AB Turbinvägen 9, Nacka Sweden Tel: Fax: Arthrex Korea Rosedale Building #1137, 724 Sooseo-dong, Gangnam-gu, Seoul Korea Tel: Fax: Arthrex Mexico, S.A. de C.V. Insurgentes Sur 600 Mezanine, Col. Del Valle Mexico D.F Mexico Tel: Fax: Arthrex Swiss AG Müllerenstrasse 3, 8604 Volketswil Switzerland Tel: Fax: 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. Designed in conjunction with Giancarlo Puddu, M.D., Rome, Italy; Peter J. Fowler, M.D., London, ONT, Canada; and Ned Amendola, M.D., Iowa City, Iowa. U.S. PATENT NOS. 5,620,448; 5,749,875 and PATENT PENDING Copyright Arthrex Inc., All rights reserved. LT0113E

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