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

Opening Wedge OsteotomyTibial Opening Wedge Osteotomy System Opening Wedge Osteotomy with Titanium Plates and Screws and OSferion® B-TCP Osteotomy Wedge Surgical Technique Arthrex,

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Page 1: Opening Wedge OsteotomyTibial Opening Wedge Osteotomy System Opening Wedge Osteotomy with Titanium Plates and Screws and OSferion® B-TCP Osteotomy Wedge Surgical Technique Arthrex,

Ope

ning

Wed

ge O

steo

tom

y

Tibial Opening Wedge Osteotomy Systemwith Titanium Plates and Screws and OSferion® B-TCP Osteotomy Wedge

Surgical Technique

Arthrex, Inc.1370 Creekside Boulevard, Naples, Florida 34108-1945 • USA

Tel: 239-643-5553 • Fax: 239-598-5534 • Web site: www.arthrex.com

Arthrex GmbHLiebigstrasse 13, 85757 Karlsfeld/Munich • Germany

Tel: +49-8131-59570 • Fax: +49-8131-5957-565

Arthrex IberoaméricaHoward Hughes Tower, 6701 Center Drive West, Suite 550, Los Angeles, California 90045 • USA

Tel: 310-670-6080 • Fax: 310-670-6087

Arthrex S.A.S.5 Avenue Pierre et Marie Curie, 59260 Lezennes • France

Tel: +33-3-20-05-72-72 • Fax: +33-3-20-05-72-70

Arthrex CanadaLasswell Medical Co., Ltd., 405 Industrial Drive, Unit 21, Milton, Ontario • Canada L9T 5B1

Tel: 905-876-4604 • Fax: 905-876-1004 • Toll-Free: 1-800-224-0302

Arthrex GesmbH Triesterstrasse 10/1 • 2351 Wiener Neudorf • Austria

Tel: +43-2236-89-33-50-0 • Fax: +43-2236-89-33-50-10

Arthrex BvbATechnologiepark Satenrozen, Satenrozen 1a, 2550 Kontich • Belgium

Tel: +32-3-2169199 • Fax: +32-3-2162059

Arthrex Ltd.Unit 16, President Buildings, Savile Street East, Sheffield S4 7UQ • England

Tel: +44-114-2767788 • Fax: +44-114-2767744

Arthrex Hellas - Medical Instruments SA103, Ethnikis Antistasseos str., N. Psichico 154 51 Athens • Greece

Tel: +30-210-8079980 • Fax: +30-210-8000379

Arthrex Sverige ABTurbinvägen 9, 131 60 Nacka • Sweden

Tel: +46-8-556 744 40 • Fax: +46-8-556 744 41

Arthrex KoreaRosedale Building #1137, 724 Sooseo-dong, Gangnam-gu, Seoul 135-744 • Korea

Tel: +82-2-3413-3033 • Fax: +82-2-3413-3035

Arthrex Mexico, S.A. de C.V.Insurgentes Sur 600 Mezanine, Col. Del Valle Mexico D.F. 03100 • Mexico

Tel: +52-55-91722820 • Fax: +52-55-56-87-64-72

Arthrex Swiss AGMüllerenstrasse 3, 8604 Volketswil • SwitzerlandTel: +41-43-399-45-20 • Fax: +41-43-399-45-29

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., 2007. All rights reserved. LT0113E

Opening Wedge Osteotomy System Set (AR-13305S) includes: Osteotomy Wedge AR-13300Osteotome Handle AR-13301Osteotome Blades, 10 mm AR-13302-10Osteotome Blades, 25 mm AR-13302-25Osteotome Blades, 35 mm AR-13302-35Parallel Guide Sleeve Body AR-13304-1Parallel Guide Sleeve, qty. 2 AR-13304-2Osteotomy Guide Assembly AR-13305Osteotomy Cutting Guide AR-13306-01Osteotomy Cutting Guide Pin AR-13306-02Alignment Rod AR-13308Femoral Osteotomy Retractor AR-13309Radiolucent Retractor AR-13310Universal Handle Extractor AR-13314Cutting Guide for HTO AR-13315Bone Graft Tamp AR-13317Application Bar for HTO Plates AR-13318Drill Guide for HTO AR-13320Drill Guide for HTO Titanium Plates AR-13321Bending Irons for HTO Plates, qty. 2 AR-13322Depth Device for Osteotome Jack AR-13323GOsteotome Jack, 35 mm AR-13323-35Osteotome Jack w/Screwdriver, 35 mm AR-13323-35SWedge Trial for HTO AR-13324A/P Sloped Osteotomy Wedge Trial, large AR-13325LA/P Sloped Osteotomy Wedge Trial, small AR-13325SScrewdriver, 3.5 mm hex AR-13326Screwdriver, 90˚, 3.5 mm hex AR-13326-90Locking Guide for HTO Titanium Plates AR-13327Depth Device, large AR-4167Opening Wedge Osteotomy System Instrumentation Case AR-13307Storage Case for HTO Plates AR-13307P

Accessories: Patellar Tendon Retractor AR-13312Medial Retractor for HTO AR-13313Osteotomy Guide Pins, 2.4 mm, qty. 6 (“breakaway”) AR-13303-2.4Osteotomy Guide Pins, 3 mm, qty. 6 AR-13303-3.0Drill for HTO Titanium Screws, qty. 6 AR-13319Osteotome Jack, 25 mm AR-13323-25

Bone Graft Substitute: OSferion Osteotomy Wedge, 7 mm x 30 mm AR-13370-1OSferion Osteotomy Wedge, 10 mm x 30 mm AR-13370-2OSferion Osteotomy Wedge, 12 mm x 35 mm AR-13370-3OSferion Osteotomy Wedge, 15 mm x 35 mm AR-13370-4

Titanium Screws: HTO Plate Screw, 4.5 mm x 34 mm, cortical AR-13334THTO Plate Screw, 4.5 mm x 36 mm, cortical AR-13336THTO Plate Screw, 4.5 mm x 38 mm, cortical AR-13338THTO Plate Screw, 4.5 mm x 40 mm, cortical AR-13340THTO Plate Screw, 4.5 mm x 42 mm, cortical AR-13342THTO Plate Screw, 4.5 mm x 44 mm, cortical AR-13344THTO Plate Screw, 4.5 mm x 46 mm, cortical AR-13346THTO Plate Screw, 4.5 mm x 48 mm, cortical AR-13348THTO Plate Screw, 4.5 mm x 50 mm, cortical AR-13350THTO Plate Screw, 4.5 mm x 52 mm, cortical AR-13352THTO Plate Screw, 4.5 mm x 54 mm, cortical AR-13354THTO Plate Screw, 4.5 mm x 56 mm, cortical AR-13356THTO Plate Screw, 4.5 mm x 58 mm, cortical AR-13358THTO Plate Screw, 4.5 mm x 60 mm, cortical AR-13360THTO Plate Screw, 6.5 mm x 35 mm, cancellous AR-13235THTO Plate Screw, 6.5 mm x 40 mm, cancellous AR-13240THTO Plate Screw, 6.5 mm x 45 mm, cancellous AR-13245THTO Plate Screw, 6.5 mm x 50 mm, cancellous AR-13250THTO Plate Screw, 6.5 mm x 55 mm, cancellous AR-13255THTO Plate Screw, 6.5 mm x 60 mm, cancellous AR-13260THTO Plate Screw, 6.5 mm x 65 mm, cancellous AR-13265THTO Plate Screw, 6.5 mm x 70 mm, cancellous AR-13270T

Titanium Plates: Tibial A/P Sloped Osteotomy Plate, 5 mm AR-13200ST-05.0Tibial A/P Sloped Osteotomy Plate, 7.5 mm AR-13200ST-07.5Tibial A/P Sloped Osteotomy Plate, 9 mm AR-13200ST-09.0Tibial A/P Sloped Osteotomy Plate, 10 mm AR-13200ST-10.0Tibial A/P Sloped Osteotomy Plate, 11 mm AR-13200ST-11.0Tibial A/P Sloped Osteotomy Plate, 12.5 mm AR-13200ST-12.5Tibial A/P Sloped Osteotomy Plate, 15 mm AR-13200ST-15.0Tibial A/P Sloped Osteotomy Plate, 17.5 mm AR-13200ST-17.5

Tibial Opening Wedge Osteotomy Plate, 3 mm AR-13200T-03.0Tibial Opening Wedge Osteotomy Plate, 5 mm AR-13200T-05.0Tibial Opening Wedge Osteotomy Plate, 7.5 mm AR-13200T-07.5Tibial Opening Wedge Osteotomy Plate, 9 mm AR-13200T-09.0Tibial Opening Wedge Osteotomy Plate, 10 mm AR-13200T-10.0Tibial Opening Wedge Osteotomy Plate, 11 mm AR-13200T-11.0Tibial Opening Wedge Osteotomy Plate, 12.5 mm AR-13200T-12.5Tibial Opening Wedge Osteotomy Plate, 15 mm AR-13200T-15.0Tibial Opening Wedge Osteotomy Plate, 17.5 mm AR-13200T-17.5

Page 2: Opening Wedge OsteotomyTibial Opening Wedge Osteotomy System Opening Wedge Osteotomy with Titanium Plates and Screws and OSferion® B-TCP Osteotomy Wedge Surgical Technique Arthrex,

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.

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.

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)

1

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 visual-izing the laser marks on the drill as it exits the drill guide (a)).

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.

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 bush-ing. Finish screw insertion and repeat for all screw holes using 6.5 mm screws proximally and 4.5 mm cortical screws distally.

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.

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.)

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.

3

2

6

4 5

7 10

8 9

11

Concomitant HTO and ACL Procedure

Tibial Opening Wedge Osteotomy System w/Titanium Plates and Screws

Surgical Technique

a

Page 3: Opening Wedge OsteotomyTibial Opening Wedge Osteotomy System Opening Wedge Osteotomy with Titanium Plates and Screws and OSferion® B-TCP Osteotomy Wedge Surgical Technique Arthrex,

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.

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.

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)

1

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 visual-izing the laser marks on the drill as it exits the drill guide (a)).

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.

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 bush-ing. Finish screw insertion and repeat for all screw holes using 6.5 mm screws proximally and 4.5 mm cortical screws distally.

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.

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.)

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.

3

2

6

4 5

7 10

8 9

11

Concomitant HTO and ACL Procedure

Tibial Opening Wedge Osteotomy System w/Titanium Plates and Screws

Surgical Technique

a

Page 4: Opening Wedge OsteotomyTibial Opening Wedge Osteotomy System Opening Wedge Osteotomy with Titanium Plates and Screws and OSferion® B-TCP Osteotomy Wedge Surgical Technique Arthrex,

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.

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.

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)

1

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 visual-izing the laser marks on the drill as it exits the drill guide (a)).

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.

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 bush-ing. Finish screw insertion and repeat for all screw holes using 6.5 mm screws proximally and 4.5 mm cortical screws distally.

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.

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.)

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.

3

2

6

4 5

7 10

8 9

11

Concomitant HTO and ACL Procedure

Tibial Opening Wedge Osteotomy System w/Titanium Plates and Screws

Surgical Technique

a

Page 5: Opening Wedge OsteotomyTibial Opening Wedge Osteotomy System Opening Wedge Osteotomy with Titanium Plates and Screws and OSferion® B-TCP Osteotomy Wedge Surgical Technique Arthrex,

Ope

ning

Wed

ge O

steo

tom

y

Tibial Opening Wedge Osteotomy Systemwith Titanium Plates and Screws and OSferion® B-TCP Osteotomy Wedge

Surgical Technique

Arthrex, Inc.1370 Creekside Boulevard, Naples, Florida 34108-1945 • USA

Tel: 239-643-5553 • Fax: 239-598-5534 • Web site: www.arthrex.com

Arthrex GmbHLiebigstrasse 13, 85757 Karlsfeld/Munich • Germany

Tel: +49-8131-59570 • Fax: +49-8131-5957-565

Arthrex IberoaméricaHoward Hughes Tower, 6701 Center Drive West, Suite 550, Los Angeles, California 90045 • USA

Tel: 310-670-6080 • Fax: 310-670-6087

Arthrex S.A.S.5 Avenue Pierre et Marie Curie, 59260 Lezennes • France

Tel: +33-3-20-05-72-72 • Fax: +33-3-20-05-72-70

Arthrex CanadaLasswell Medical Co., Ltd., 405 Industrial Drive, Unit 21, Milton, Ontario • Canada L9T 5B1

Tel: 905-876-4604 • Fax: 905-876-1004 • Toll-Free: 1-800-224-0302

Arthrex GesmbH Triesterstrasse 10/1 • 2351 Wiener Neudorf • Austria

Tel: +43-2236-89-33-50-0 • Fax: +43-2236-89-33-50-10

Arthrex BvbATechnologiepark Satenrozen, Satenrozen 1a, 2550 Kontich • Belgium

Tel: +32-3-2169199 • Fax: +32-3-2162059

Arthrex Ltd.Unit 16, President Buildings, Savile Street East, Sheffield S4 7UQ • England

Tel: +44-114-2767788 • Fax: +44-114-2767744

Arthrex Hellas - Medical Instruments SA103, Ethnikis Antistasseos str., N. Psichico 154 51 Athens • Greece

Tel: +30-210-8079980 • Fax: +30-210-8000379

Arthrex Sverige ABTurbinvägen 9, 131 60 Nacka • Sweden

Tel: +46-8-556 744 40 • Fax: +46-8-556 744 41

Arthrex KoreaRosedale Building #1137, 724 Sooseo-dong, Gangnam-gu, Seoul 135-744 • Korea

Tel: +82-2-3413-3033 • Fax: +82-2-3413-3035

Arthrex Mexico, S.A. de C.V.Insurgentes Sur 600 Mezanine, Col. Del Valle Mexico D.F. 03100 • Mexico

Tel: +52-55-91722820 • Fax: +52-55-56-87-64-72

Arthrex Swiss AGMüllerenstrasse 3, 8604 Volketswil • SwitzerlandTel: +41-43-399-45-20 • Fax: +41-43-399-45-29

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., 2007. All rights reserved. LT0113E

Opening Wedge Osteotomy System Set (AR-13305S) includes: Osteotomy Wedge AR-13300Osteotome Handle AR-13301Osteotome Blades, 10 mm AR-13302-10Osteotome Blades, 25 mm AR-13302-25Osteotome Blades, 35 mm AR-13302-35Parallel Guide Sleeve Body AR-13304-1Parallel Guide Sleeve, qty. 2 AR-13304-2Osteotomy Guide Assembly AR-13305Osteotomy Cutting Guide AR-13306-01Osteotomy Cutting Guide Pin AR-13306-02Alignment Rod AR-13308Femoral Osteotomy Retractor AR-13309Radiolucent Retractor AR-13310Universal Handle Extractor AR-13314Cutting Guide for HTO AR-13315Bone Graft Tamp AR-13317Application Bar for HTO Plates AR-13318Drill Guide for HTO AR-13320Drill Guide for HTO Titanium Plates AR-13321Bending Irons for HTO Plates, qty. 2 AR-13322Depth Device for Osteotome Jack AR-13323GOsteotome Jack, 35 mm AR-13323-35Osteotome Jack w/Screwdriver, 35 mm AR-13323-35SWedge Trial for HTO AR-13324A/P Sloped Osteotomy Wedge Trial, large AR-13325LA/P Sloped Osteotomy Wedge Trial, small AR-13325SScrewdriver, 3.5 mm hex AR-13326Screwdriver, 90˚, 3.5 mm hex AR-13326-90Locking Guide for HTO Titanium Plates AR-13327Depth Device, large AR-4167Opening Wedge Osteotomy System Instrumentation Case AR-13307Storage Case for HTO Plates AR-13307P

Accessories: Patellar Tendon Retractor AR-13312Medial Retractor for HTO AR-13313Osteotomy Guide Pins, 2.4 mm, qty. 6 (“breakaway”) AR-13303-2.4Osteotomy Guide Pins, 3 mm, qty. 6 AR-13303-3.0Drill for HTO Titanium Screws, qty. 6 AR-13319Osteotome Jack, 25 mm AR-13323-25

Bone Graft Substitute: OSferion Osteotomy Wedge, 7 mm x 30 mm AR-13370-1OSferion Osteotomy Wedge, 10 mm x 30 mm AR-13370-2OSferion Osteotomy Wedge, 12 mm x 35 mm AR-13370-3OSferion Osteotomy Wedge, 15 mm x 35 mm AR-13370-4

Titanium Screws: HTO Plate Screw, 4.5 mm x 34 mm, cortical AR-13334THTO Plate Screw, 4.5 mm x 36 mm, cortical AR-13336THTO Plate Screw, 4.5 mm x 38 mm, cortical AR-13338THTO Plate Screw, 4.5 mm x 40 mm, cortical AR-13340THTO Plate Screw, 4.5 mm x 42 mm, cortical AR-13342THTO Plate Screw, 4.5 mm x 44 mm, cortical AR-13344THTO Plate Screw, 4.5 mm x 46 mm, cortical AR-13346THTO Plate Screw, 4.5 mm x 48 mm, cortical AR-13348THTO Plate Screw, 4.5 mm x 50 mm, cortical AR-13350THTO Plate Screw, 4.5 mm x 52 mm, cortical AR-13352THTO Plate Screw, 4.5 mm x 54 mm, cortical AR-13354THTO Plate Screw, 4.5 mm x 56 mm, cortical AR-13356THTO Plate Screw, 4.5 mm x 58 mm, cortical AR-13358THTO Plate Screw, 4.5 mm x 60 mm, cortical AR-13360THTO Plate Screw, 6.5 mm x 35 mm, cancellous AR-13235THTO Plate Screw, 6.5 mm x 40 mm, cancellous AR-13240THTO Plate Screw, 6.5 mm x 45 mm, cancellous AR-13245THTO Plate Screw, 6.5 mm x 50 mm, cancellous AR-13250THTO Plate Screw, 6.5 mm x 55 mm, cancellous AR-13255THTO Plate Screw, 6.5 mm x 60 mm, cancellous AR-13260THTO Plate Screw, 6.5 mm x 65 mm, cancellous AR-13265THTO Plate Screw, 6.5 mm x 70 mm, cancellous AR-13270T

Titanium Plates: Tibial A/P Sloped Osteotomy Plate, 5 mm AR-13200ST-05.0Tibial A/P Sloped Osteotomy Plate, 7.5 mm AR-13200ST-07.5Tibial A/P Sloped Osteotomy Plate, 9 mm AR-13200ST-09.0Tibial A/P Sloped Osteotomy Plate, 10 mm AR-13200ST-10.0Tibial A/P Sloped Osteotomy Plate, 11 mm AR-13200ST-11.0Tibial A/P Sloped Osteotomy Plate, 12.5 mm AR-13200ST-12.5Tibial A/P Sloped Osteotomy Plate, 15 mm AR-13200ST-15.0Tibial A/P Sloped Osteotomy Plate, 17.5 mm AR-13200ST-17.5

Tibial Opening Wedge Osteotomy Plate, 3 mm AR-13200T-03.0Tibial Opening Wedge Osteotomy Plate, 5 mm AR-13200T-05.0Tibial Opening Wedge Osteotomy Plate, 7.5 mm AR-13200T-07.5Tibial Opening Wedge Osteotomy Plate, 9 mm AR-13200T-09.0Tibial Opening Wedge Osteotomy Plate, 10 mm AR-13200T-10.0Tibial Opening Wedge Osteotomy Plate, 11 mm AR-13200T-11.0Tibial Opening Wedge Osteotomy Plate, 12.5 mm AR-13200T-12.5Tibial Opening Wedge Osteotomy Plate, 15 mm AR-13200T-15.0Tibial Opening Wedge Osteotomy Plate, 17.5 mm AR-13200T-17.5

Page 6: Opening Wedge OsteotomyTibial Opening Wedge Osteotomy System Opening Wedge Osteotomy with Titanium Plates and Screws and OSferion® B-TCP Osteotomy Wedge Surgical Technique Arthrex,

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Tibial Opening Wedge Osteotomy Systemwith Titanium Plates and Screws and OSferion® B-TCP Osteotomy Wedge

Surgical Technique

Arthrex, Inc.1370 Creekside Boulevard, Naples, Florida 34108-1945 • USA

Tel: 239-643-5553 • Fax: 239-598-5534 • Web site: www.arthrex.com

Arthrex GmbHLiebigstrasse 13, 85757 Karlsfeld/Munich • Germany

Tel: +49-8131-59570 • Fax: +49-8131-5957-565

Arthrex IberoaméricaHoward Hughes Tower, 6701 Center Drive West, Suite 550, Los Angeles, California 90045 • USA

Tel: 310-670-6080 • Fax: 310-670-6087

Arthrex S.A.S.5 Avenue Pierre et Marie Curie, 59260 Lezennes • France

Tel: +33-3-20-05-72-72 • Fax: +33-3-20-05-72-70

Arthrex CanadaLasswell Medical Co., Ltd., 405 Industrial Drive, Unit 21, Milton, Ontario • Canada L9T 5B1

Tel: 905-876-4604 • Fax: 905-876-1004 • Toll-Free: 1-800-224-0302

Arthrex GesmbH Triesterstrasse 10/1 • 2351 Wiener Neudorf • Austria

Tel: +43-2236-89-33-50-0 • Fax: +43-2236-89-33-50-10

Arthrex BvbATechnologiepark Satenrozen, Satenrozen 1a, 2550 Kontich • Belgium

Tel: +32-3-2169199 • Fax: +32-3-2162059

Arthrex Ltd.Unit 16, President Buildings, Savile Street East, Sheffield S4 7UQ • England

Tel: +44-114-2767788 • Fax: +44-114-2767744

Arthrex Hellas - Medical Instruments SA103, Ethnikis Antistasseos str., N. Psichico 154 51 Athens • Greece

Tel: +30-210-8079980 • Fax: +30-210-8000379

Arthrex Sverige ABTurbinvägen 9, 131 60 Nacka • Sweden

Tel: +46-8-556 744 40 • Fax: +46-8-556 744 41

Arthrex KoreaRosedale Building #1137, 724 Sooseo-dong, Gangnam-gu, Seoul 135-744 • Korea

Tel: +82-2-3413-3033 • Fax: +82-2-3413-3035

Arthrex Mexico, S.A. de C.V.Insurgentes Sur 600 Mezanine, Col. Del Valle Mexico D.F. 03100 • Mexico

Tel: +52-55-91722820 • Fax: +52-55-56-87-64-72

Arthrex Swiss AGMüllerenstrasse 3, 8604 Volketswil • SwitzerlandTel: +41-43-399-45-20 • Fax: +41-43-399-45-29

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., 2007. All rights reserved. LT0113E

Opening Wedge Osteotomy System Set (AR-13305S) includes: Osteotomy Wedge AR-13300Osteotome Handle AR-13301Osteotome Blades, 10 mm AR-13302-10Osteotome Blades, 25 mm AR-13302-25Osteotome Blades, 35 mm AR-13302-35Parallel Guide Sleeve Body AR-13304-1Parallel Guide Sleeve, qty. 2 AR-13304-2Osteotomy Guide Assembly AR-13305Osteotomy Cutting Guide AR-13306-01Osteotomy Cutting Guide Pin AR-13306-02Alignment Rod AR-13308Femoral Osteotomy Retractor AR-13309Radiolucent Retractor AR-13310Universal Handle Extractor AR-13314Cutting Guide for HTO AR-13315Bone Graft Tamp AR-13317Application Bar for HTO Plates AR-13318Drill Guide for HTO AR-13320Drill Guide for HTO Titanium Plates AR-13321Bending Irons for HTO Plates, qty. 2 AR-13322Depth Device for Osteotome Jack AR-13323GOsteotome Jack, 35 mm AR-13323-35Osteotome Jack w/Screwdriver, 35 mm AR-13323-35SWedge Trial for HTO AR-13324A/P Sloped Osteotomy Wedge Trial, large AR-13325LA/P Sloped Osteotomy Wedge Trial, small AR-13325SScrewdriver, 3.5 mm hex AR-13326Screwdriver, 90˚, 3.5 mm hex AR-13326-90Locking Guide for HTO Titanium Plates AR-13327Depth Device, large AR-4167Opening Wedge Osteotomy System Instrumentation Case AR-13307Storage Case for HTO Plates AR-13307P

Accessories: Patellar Tendon Retractor AR-13312Medial Retractor for HTO AR-13313Osteotomy Guide Pins, 2.4 mm, qty. 6 (“breakaway”) AR-13303-2.4Osteotomy Guide Pins, 3 mm, qty. 6 AR-13303-3.0Drill for HTO Titanium Screws, qty. 6 AR-13319Osteotome Jack, 25 mm AR-13323-25

Bone Graft Substitute: OSferion Osteotomy Wedge, 7 mm x 30 mm AR-13370-1OSferion Osteotomy Wedge, 10 mm x 30 mm AR-13370-2OSferion Osteotomy Wedge, 12 mm x 35 mm AR-13370-3OSferion Osteotomy Wedge, 15 mm x 35 mm AR-13370-4

Titanium Screws: HTO Plate Screw, 4.5 mm x 34 mm, cortical AR-13334THTO Plate Screw, 4.5 mm x 36 mm, cortical AR-13336THTO Plate Screw, 4.5 mm x 38 mm, cortical AR-13338THTO Plate Screw, 4.5 mm x 40 mm, cortical AR-13340THTO Plate Screw, 4.5 mm x 42 mm, cortical AR-13342THTO Plate Screw, 4.5 mm x 44 mm, cortical AR-13344THTO Plate Screw, 4.5 mm x 46 mm, cortical AR-13346THTO Plate Screw, 4.5 mm x 48 mm, cortical AR-13348THTO Plate Screw, 4.5 mm x 50 mm, cortical AR-13350THTO Plate Screw, 4.5 mm x 52 mm, cortical AR-13352THTO Plate Screw, 4.5 mm x 54 mm, cortical AR-13354THTO Plate Screw, 4.5 mm x 56 mm, cortical AR-13356THTO Plate Screw, 4.5 mm x 58 mm, cortical AR-13358THTO Plate Screw, 4.5 mm x 60 mm, cortical AR-13360THTO Plate Screw, 6.5 mm x 35 mm, cancellous AR-13235THTO Plate Screw, 6.5 mm x 40 mm, cancellous AR-13240THTO Plate Screw, 6.5 mm x 45 mm, cancellous AR-13245THTO Plate Screw, 6.5 mm x 50 mm, cancellous AR-13250THTO Plate Screw, 6.5 mm x 55 mm, cancellous AR-13255THTO Plate Screw, 6.5 mm x 60 mm, cancellous AR-13260THTO Plate Screw, 6.5 mm x 65 mm, cancellous AR-13265THTO Plate Screw, 6.5 mm x 70 mm, cancellous AR-13270T

Titanium Plates: Tibial A/P Sloped Osteotomy Plate, 5 mm AR-13200ST-05.0Tibial A/P Sloped Osteotomy Plate, 7.5 mm AR-13200ST-07.5Tibial A/P Sloped Osteotomy Plate, 9 mm AR-13200ST-09.0Tibial A/P Sloped Osteotomy Plate, 10 mm AR-13200ST-10.0Tibial A/P Sloped Osteotomy Plate, 11 mm AR-13200ST-11.0Tibial A/P Sloped Osteotomy Plate, 12.5 mm AR-13200ST-12.5Tibial A/P Sloped Osteotomy Plate, 15 mm AR-13200ST-15.0Tibial A/P Sloped Osteotomy Plate, 17.5 mm AR-13200ST-17.5

Tibial Opening Wedge Osteotomy Plate, 3 mm AR-13200T-03.0Tibial Opening Wedge Osteotomy Plate, 5 mm AR-13200T-05.0Tibial Opening Wedge Osteotomy Plate, 7.5 mm AR-13200T-07.5Tibial Opening Wedge Osteotomy Plate, 9 mm AR-13200T-09.0Tibial Opening Wedge Osteotomy Plate, 10 mm AR-13200T-10.0Tibial Opening Wedge Osteotomy Plate, 11 mm AR-13200T-11.0Tibial Opening Wedge Osteotomy Plate, 12.5 mm AR-13200T-12.5Tibial Opening Wedge Osteotomy Plate, 15 mm AR-13200T-15.0Tibial Opening Wedge Osteotomy Plate, 17.5 mm AR-13200T-17.5