ORTHOLOC 3Di. Foot Reconstruction System SURGIC AL TECHNIQUE

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1 ORTHOLOC 3Di Foot Reconstruction System S C R E W TA R G E T I N G G U I D E SURGIC AL TECHNIQUE

2 SURGEON DESIGN TEAM The ORTHOLOC 3Di Foot Reconstruction System was developed in conjuction with: ORTHOLOC 3Di Foot Reconstruction System SCREW TARGETING GUIDE SURGICAL TECHNIQUE Robert B. Anderson, MD OrthoCarolina Charlotte, NC Gregory C. Berlet, MD Orthopedic Foot and Ankle Center Columbus, OH Bruce E. Cohen, MD OrthoCarolina Charlotte, NC W. Hodges Davis, MD OrthoCarolina Charlotte, NC Christopher F. Hyer, DPM Orthopedic Foot and Ankle Center Columbus, OH Carroll P. Jones, MD OrthoCarolina Charlotte, NC Thomas H. Lee, MD Orthopedic Foot and Ankle Center Columbus, OH

3 Contents Chapter Chapter Chapter Chapter Chapter Chapter 6 11 Introduction System Features Intended Use Indications Contraindications Device Description Screw Targeting Guide Module Preoperative Planning Implant Selection Plates Screws Surgical Technique General System Procedures MTP Arthrodesis Surgical Approach Explant Information Postoperative Management Ordering Information Wright recognizes that proper surgical procedures and techniques are the responsibility of the medical professional. The following guidelines are furnished for information purposes only. Each surgeon must evaluate the appropriateness of the procedures based on his or her personal medical training, experience, and patient condition. Prior to use of the system, the surgeon should refer to the product Instructions For Use package insert for additional warnings, precautions, indications, contraindications and adverse effects. Instructions For Use package inserts are also available by contacting the manufacturer. Contact information can be found on the back of this surgical technique and the Instructions For Use package inserts are available on wright.com under the link for Prescribing Information. Please contact your local Wright representative for product availability. Chapter 1 Description of Chapter 3

4 Introduction chapter 1 15 o 15 o The ORTHOLOC 3Di Foot Reconstruction System is a multi-indication foot reconstruction solution providing indication specific implants and instruments designed to address the unique demands of the forefoot and midfoot. Each ORTHOLOC 3Di implant has been designed with a focus on strength, versatility, and low-profile anatomic contours. Additionally, the employment of the ORTHOLOC 3Di Polyaxial Locking Technology allows the surgeon the option of 2.7mm or 3.5mm locking screws capable of locking at up to 15 off axis to the plate. System Features Universal plate hole accepts 2.7mm and 3.5mm locking and non-locking screws Four indication and anatomic specific plate designs ORTHOLOC 3Di Polyaxial locking capability Compression holes in selected plates Anatomic and indication specific implants 4 Chapter 1 Introduction

5 Intended Use chapter 2 Indications The ORTHOLOC 3Di Hallux System is intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of bones of the feet and toes. Specific examples include: First metatarsal osteotomies for hallux valgus correction including: o Opening base wedge osteotomy o Closing base wedge osteotomy o Crescentic osteotomy o Proximal Chevron osteotomy o Distal Chevron osteotomy (Austin) First metatarsal fracture fixation Arthrodesis of the first metatarsalcuneiform joint (Lapidus Fusion) Arthrodesis of the first metatarsophalangeal joint (MTP) including: o Primary MTP Fusion due to hallux rigidus and/or hallux valgus o Revision MTP Fusion o Revision of failed first MTP Arthroplasty implant Contraindications No product specific contraindications. Prior to use of the system, the surgeon should refer to the product package insert for complete warnings, precautions, indications, contraindications and adverse effects. Package inserts are also available by contacting the manufacturer. Contact information can be found on the back of this surgical technique and the package insert is available on the website listed. Chapter 2 Intended Use 5

6 Device Description chapter 3 ORTHOLOC 3Di Screw Targeting Guide Module The ORTHOLOC 3Di Screw Targeting Guide in FIGURE 1 has been designed to place a lag screw plantar to a ORTHOLOC 3Di plate while avoiding collision with an on-axis locking screw. Please see the full surgical technique (009149) for a comprehensive overview of indications, implant solutions, and system instrumentation. ORTHOLOC 3Di Screw Targeting Guide Drill Guide Assembly Hole Articulating Guide Arm Targeting Guide ( ) Tissue Protector Guide Hole Figure 1 6 Chapter 3 Device Description

7 Preoperative Planning chapter 4 Implant Selection Plates Like any lower extremity procedure, preoperative planning is vital to the overall outcome of joint fusion and osteotomy fixation. Careful consideration must be given to implant selection. Choose an implant that addresses the specific needs dictated by the indication, patient anatomy, and overall surgical goals. First BOW Lapidus First First Metatarsal Plate Plate MTP Plate MTP Plate Plate Primary Revision Hallux Valgus Procedures Opening Base Wedge X Closing Base Wedge X X Crescentic Osteotomy X Proximal Chevron X Distal Chevron (Austin) X Lapidus Fusion X X 1st Metatarsal Fracture X Hallux Rigidus Procedures MTP Primary Fusion MTP Revision MTP Arthroplasty Revision X X X NOTE: The ORTHOLOC 3Di Screw Targeting Guide is optimally designed for use with ORTHOLOC 3Di MTP plates. Chapter 4 Preoperative Planning 7

8 Surgical Procedure chapter 5 General System Procedures 1.4mm K-wire Targeting Guide ( ) Drill Guide (2.0mm or 2.8mm) Tissue Protector ( ) Figure 2 Using the provided temporary fixation pins (P/N ), provisionally fixate the plate to the bone proximally and distally to the joint. FIGURE 3 Temporary fixation pins can be placed in the temporary fixation holes (if provided) and/or any 3Di locking screw hole. With the plate provisionally fixed to the bone, dorsiflexion, valgus angle, and plate position can now be assessed. Generally, 5 to 10 of dorsiflexion is desired for fusion. Place the ORTHOLOC 3Di tray lid on the plantar surface of the foot to evaluate the desired dorsiflexion. Fluoroscopy should also be utilized to evaluate valgus angle and proper plate placement. Figure 3 Interfragmentary Screw Placement The use of an interfragmentary compression screw across a fusion site can be used to supplement plate fixation, create compression, and prevent plantar gapping. The use of the ORTHOLOC 3Di Lag Screw Targeting guide is recommended to reduce the risk of screw collision and ensure accurate placement. 8 Chapter 5 Surgical Procedure

9 Step 1 Provisionally place the ORTHOLOC 3Di MTP Plate over the MTP joint using two temporary Fixation Pins ( ). Olive wires can be used as an alternative to fixation pins. One olive wire can be placed in the small pin hole located in the center of the plate. FIGURE Pin hole Figure 4 - Identification of MTP plate holes Figure 5 - Targeting Guide assembled to the MTP plate with K-wire Guide NOTE: 1.4mm K-wire is the maximum diameter used with the Screw Targeting Guide. Step 2 Assemble the Targeting Guide by placing a Locking Drill Guide (2.0mm or 2.8mm) through the end shaped like an arrow head. A 2.8 Locking Drill ( ) has been placed into plate hole 6 as shown in FIGURE 5. The Drill Guide can be placed into plate hole 5 if desired. Next, place a Tissue Protector ( ) into one of two Tissue Protector holes on the Targeting Guide. Adjust the Targeting Guide so that the K-wire aligns with the planar medial aspect of the proximal phalanx, just distal to the proximal flare. Using a power driver, place 1.4mm K-wire (DSDS1014) through the tissue protector, directed towards the locking drill guide. Wire placement should be verified fluoroscopically in the A/P and lateral views. Once verified, remove the compression Screw Targeting Guide, and place the interfrag screw per proper surgical technique. FIGURES 6 & 7. Figure 6 Figure 7 Chapter 5 Surgical Procedure 9

10 Step 3 Using the Drill Guide of choice, pre-drill the screw holes. Place ORTHOLOC 3Di screws into the distal plate holes. Next place a nonlocking compression screw into plate hole 4 (compression slot). FIGURE 8 With a non-locking screw placed into the compression slot, locking or non-locking screws can be placed into holes 5 or 6. The order in which screws are placed into holes 5 and 6 are up to surgeon. Figure 8 - Insertion of non-locking screw into the compression slot Figure 9 - Final Construct Explant Information Removal of the plate may be performed by first extracting the plate screws using the STAR 15 Straight Driver (58861T15) and then removing the plate from the bone. If the removal of the implant is required due to revision or failure of the device, the surgeon should contact the manufacturer using the contact information located on the back cover of this surgical technique to receive instructions for returning the explanted device to the manufacturer for investigation. Postoperative Management Postoperative care is the responsibility of the medical professional. 10 Chapter 5 Surgical Procedure

11 Ordering Information chapter 6 ORTHOLOC 3Di Screw Targeting Guide KIT#5886KIT3 Part # Description mm K-wire Tissue Protector Targeting Guide Screw Targeting Guide Caddy Chapter 6 Ordering Information 11

12 1023 Cherry Road Memphis, TN Quai Charles de Gaulle Lyon France +33 (0) Amor Way Letchworth Garden City Hertfordshire SG6 1UG United Kingdom +44 (0) and denote Trademarks and Registered Trademarks of Wright Medical Group N.V. or its affiliates Wright Medical Group N.V. or its affiliates. All Rights Reserved B 13-Jul-2016

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