ORTHOLOC 3Di. Foot Reconstruction System SURGIC AL TECHNIQUE
|
|
- Shawn Chapman
- 6 years ago
- Views:
Transcription
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
ORTHOLOC 3Di. Foot Reconstruction System Midfoot Fusion Plate SURGICAL TECHNIQUE
ORTHOLOC 3Di Foot Reconstruction System Midfoot Fusion Plate SURGICAL TECHNIQUE ORTHOLOC Foot Reconstruction System Midfoot Fusion Plate SURGICAL TECHNIQUE Surgeon Design Team The ORTHOLOC 3Di Foot Reconstruction
More informationFoot Reconstruction System SURGICAL TECHNIQUE
ORTHOLOC 3Di Foot Reconstruction System SURGICAL TECHNIQUE SURGEON DESIGN TEAM The ORTHOLOC 3Di Foot Reconstruction System was developed in conjuction with: Robert B. Anderson, MD OrthoCarolina Charlotte,
More informationCHARLOTTE Lisfranc. Recontruction System SURGICAL TECHNIQUE
CHARLOTTE Lisfranc Recontruction System SURGICAL TECHNIQUE Contents Preface 3 Chapter 1 4 Chapter 2 4 4 4 4 4 Chapter 3 5 5 5 6 6 6 7 7 8 Chapter 4 8 8 9 10 Appendix 10 Introduction Indications and Contraindications
More informationORTHOLOC CROSSCHECK TECHNOLOGY OVERVIEW FOR HOSPITAL VALUE ANALYSIS COMMITTEE
ORTHOLOC CROSSCHECK TECHNOLOGY OVERVIEW FOR HOSPITAL VALUE ANALYSIS COMMITTEE Indications for Use The ORTHOLOC 3Di Foot Reconstruction System is intended for use in stabilization of fresh fractures, revision
More informationDARCO. Bow 2 Plate SURGIC AL TECHNIQUE
DARCO Bow 2 Plate SURGIC AL TECHNIQUE Contents 2 Preface 3 Chapter 1 4 Chapter 2 5 6 7 8 9 Appendix 10 10 11 Intended Use Indications/Contraindications Design Rationale Preoperative Planning Surgical Technique
More informationAnkle Fracture System SURGICAL TECHNIQUE
ORTHOLOC 3Di Ankle Fracture System SURGICAL TECHNIQUE SURGEON DESIGN TEAM The ORTHOLOC 3Di Ankle Fracture System was developed in conjuction with: Robert B. Anderson, MD OrthoCarolina Charlotte, NC ORTHOLOC
More informationCHARLOTTE. 3.0 and 4.3 Multi-Use Compression Screws SURGIC A L T ECHNIQUE
CHARLOTTE 3.0 and 4.3 Multi-Use Compression Screws SURGIC A L T ECHNIQUE CHARLOTTE 3.0 and 4.3 Multi-Use Compression Screws SURGICAL TECHNIQUE Surgical Technique as described by: Robert Anderson, MD Bruce
More informationSALVATION 3Di. Plating System SURGICAL TECHNIQUE
SALVATION 3Di Plating System SURGICAL TECHNIQUE Contents Chapter 1 4 Introduction Chapter 2 5 Intended use 5 Indications 5 Contraindications Chapter 3 6 Device Description Chapter 4 7 Preoperative Planning
More informationCHARLOTTE. Compression Staple SURGIC A L T ECHNIQUE
CHARLOTTE Compression Staple SURGIC A L T ECHNIQUE CHARLOTTE Compression Staple SURGICAL TECHNIQUE Surgical Technique as described by: Robert Anderson, MD Bruce Cohen, MD W. Hodges Davis, MD Contents Chapter
More informationImplantable K-wire SURGIC A L T ECHNIQUE
Implantable K-wire SURGIC A L T ECHNIQUE Contents Chapter 1 4 Product Information 4 Device Description 4 Indications 4 Contraindications Chapter 2 5 Surgical Technique 5 Hammertoe Correction 6 MTP Joint
More informationORTHOLOC. 3Di. Ankle Fusion Plating System SYSTEM OVERVIEW
ORTHOLOC with 3Di Technology Ankle Fusion Plating System SYSTEM OVERVIEW ORTHOLOC with 3Di Technology Ankle Fusion Plating System The ORTHOLOC Ankle Fusion Plating System with 3Di Technology contains plates
More informationMICA. Minimally Invasive Foot Surgery CHEVRON OSTEOTOMY SURGIC AL TECHNIQUE
MICA Minimally Invasive Foot Surgery CHEVRON OSTEOTOMY SURGIC AL TECHNIQUE Contents Chapter 1 4 Introduction Chapter 2 5 Indications and Warnings Chapter 3 6 Patient Positioning and Set Up Chapter 4 7
More informationPHALINX. Hammertoe Fixation SURGICAL TECHNIQUE
PHALINX Hammertoe Fixation SURGICAL TECHNIQUE Contents Chapter 1 4 Product Information 4 Device Description Chapter 2 5 Intended Use 5 Indications 5 Contraindications Chapter 3 6 Surgical Technique 6
More informationDARCO MFS. Locked plating system for reconstructive forefoot surgery.
DARCO MFS Locked plating system for reconstructive forefoot surgery. DARCO MFS Locked plating system for reconstructive forefoot surgery System Basics The DARCO MFS plating system for the forefoot has
More informationFlower Opening Wedge Plate
Flower Opening Wedge Plate PROCEDURE GUIDE www.flowerortho.com The Flower Foot & Ankle Application NC FUSION PLATE 2-HOLE COMPRESSION PLATE TMT FUSION PLATE LAPIDUS FUSION PLATE COMPRESSION T-PLATE, OBLIQUE
More informationCANNULINK. Intraossous Fixation System SURGICAL TECHNIQUE
CANNULINK Intraossous Fixation System SURGICAL TECHNIQUE Contents Chapter 1 4 Introduction The CANNULINK Advantage Indications for Use Preoperative Planning Chapter 2 5 Surgical Technique CANNULINK Standard
More informationDYNAMIC, TRANSVERSE COMPRESSION. Low Profile, Anatomic Design, Type II Anodized. Mechanical Compression Designed to Stimulate the Fusion Process
CoLink_XP_ST_080218.pdf 1 8/2/18 8:36 AM SURGICAL TECHNIQUE CoLink XP Plates DYNAMIC, TRANSVERSE COMPRESSION C M Y CM MY CY CMY K MTP Std. Plate MTP Revision Plate Lapidus Standard +1mm and +2mm Y Plate
More informationFUSEFORCE. Hand Fixation System SURGICAL TECHNIQUE
FUSEFORCE Hand Fixation System SURGICAL TECHNIQUE Contents Chapter 1 3 Chapter 2 4 Appendix A 7 Intended Use Surgical Technique Ordering Information Indication Sizing Reference Proper surgical procedures
More informationSWANSON. Flexible Hinge Toe Implant SURGIC AL TECHNIQUE
SWANSON Flexible Hinge Toe Implant SURGIC AL TECHNIQUE SWANSON flexible HINGE TOE IMPLANT with SWANSON Flexible Hinge Grommet surgical technique presented by ALFRED B. SWANSON, MD, FACS, GRAND RAPIDS,
More informationCHARLOTTE. 7.0 Multi-Use Compression Screw System SURGICAL TECHNIQUE
CHARLOTTE 7.0 Multi-Use Compression Screw System SURGICAL TECHNIQUE Contents Chapter 1 1 Chapter 2 2 Chapter 3 3-9 Chapter 4 10-12 Appendix A 13-14 Design Rationale Screw Behavior Surgical Technique Procedure
More informationVariable Angle LCP Forefoot/Midfoot System 2.4/2.7. Procedure specific plates for osteotomies, arthrodeses and fractures of the foot.
Variable Angle LCP Forefoot/Midfoot System 2.4/2.7. Procedure specific plates for osteotomies, arthrodeses and fractures of the foot. Compression technology Variable angle locking technology Anatomic and
More informationDARCO. CPS Plate SURGICAL TECHNIQUE
DARCO CPS Plate SURGICAL TECHNIQUE Contents Preface 3 Chapter 1 4 Chapter 2 5 Chapter 3 6 Appendix 9 Introduction - CPS Features Preoperative Planning Surgical Technique - Surgical Approach and Retraction
More informationThe Flower Medial Column Fusion Plate
The Flower Medial Column Fusion Plate PROCEDURE GUIDE www.flowerortho.com The Flower Foot & Ankle Application NC FUSION PLATE 2-HOLE COMPRESSION PLATE TMT FUSION PLATE LAPIDUS FUSION PLATE COMPRESSION
More informationCSS. Cannulated Screw System SURGICAL TECHNIQUE
CSS Cannulated Screw System SURGICAL TECHNIQUE Contents Chapter 1 4 Product Information 4 Device Description Chapter 2 5 Intended Use 5 Indications 5 Contraindications Chapter 3 6 Surgical Technique Appendix
More informationContents. Chapter 1 4 Chapter Chapter Chapter Chapter 5 15
Contents Chapter 1 4 Chapter 2 5 5 Chapter 3 6 6 7 Chapter 4 8 8 8 8 9 10 10 11 12 13 14 14 Chapter 5 15 Introduction Intended Use Indications Device Description Implant Options and Sizing Instrumentation
More informationDARCO. LPS Plate SURGICAL TECHNIQUE
DARCO LPS Plate SURGICAL TECHNIQUE Contents Preface 3 Chapter 1 4 Chapter 2 5 5 6 7 9 Appendix 10 10 11 Design Rationale Preoperative Planning Surgical Technique Surgical Approach Joint Preparation Surgical
More informationForefoot/Midfoot Plating System. Surgical Technique
Forefoot/Midfoot Plating System Surgical Technique Acumed is a global leader of innovative orthopaedic and medical solutions. We are dedicated to developing products, service methods, and approaches that
More informationAxi+LineTM Proximal Bunion CorrectionSystem. Surgical Technique
Axi+LineTM Proximal Bunion CorrectionSystem Surgical Technique A i Line Proximal Bunion Correction System TM Desired angle correction is built into the plate, providing a self-reducing, 5-hole construct
More informationForefoot/Midfoot Plating System
Surgical Technique Forefoot/Midfoot Plating System Acumed is a global leader of innovative orthopaedic and medical solutions. We are dedicated to developing products, service methods, and approaches that
More informationORTHOFLEX. Silicone Hammertoe Implant SURGICAL TECHNIQUE
ORTHOFLEX Silicone Hammertoe Implant SURGICAL TECHNIQUE Contents Chapter 1 4 Product Information 4 Device Description Chapter 2 4 Intended Use 5 Indications 5 Contraindications Chapter 3 6 Surgical Technique
More informationPROstep Minimally Invasive Surgery HALLUX VALGUS CORRECTION USING PROSTEP MICA MINIMALLY INVASIVE FOOT SURGERY: TWO CASE STUDIES
PROstep Minimally Invasive Surgery HALLUX VALGUS CORRECTION USING PROSTEP MICA MINIMALLY INVASIVE FOOT SURGERY: TWO CASE STUDIES AS PRESENTED BY: JOEL VERNOIS M.D. 016798A Case Study 1 PROstep Minimally
More informationCHARLOTTE. Compression Staple
CHARLOTTE Compression Staple CHARLOTTE compression staple surgical technique SURGICAL ADVISORS ROBERT ANDERSON, MD BRUCE COHEN, MD W. HODGES DAVIS, MD Proper surgical procedures and techniques are the
More informationAnchorage. Foot & Ankle. Plating System. Operative Technique
Foot & Ankle Anchorage Plating System Operative Technique Foot & Ankle Anchorage Plate System MTP Plates Lapidus Plates Lisfranc Plates Basal Osteotomy Plates Utility Plates Anchorage Cross Plate System
More informationCHARLOTTE. Snap-Off Screws SURGICAL TECHNIQUE
CHARLOTTE Snap-Off Screws SURGICAL TECHNIQUE CHARLOTTE snap-off screws surgical technique SURGICAL ADVISORS ROBERT ANDERSON, MD BRUCE COHEN, MD W. HODGES DAVIS, MD Proper surgical procedures and techniques
More informationIntegra. ADVANSYS Plating System SURGICAL TECHNIQUE
Integra ADVANSYS Plating System SURGICAL TECHNIQUE Table of Contents Dorsal Lisfranc Plate Indications...2 Contraindications...2 Description...2 Surgical Technique...3 Surgical Site Preparation...3 Step
More informationCHARLOTTE. 7.0 Multi-Use Compression Screw System SURGICAL TECHNIQUE
CHARLOTTE 7.0 Multi-Use Compression Screw System SURGICAL TECHNIQUE Contents Chapter 1 1 Chapter 2 2 2 3 4 Appendix A 5 6 Appendix B 7 8 Preoperative Planning Surgical Technique Subtalar Arthrodesis Guide
More informationLocking Forefoot/Midfoot Plating System
Locking Forefoot/Midfoot Plating System Locking Forefoot/Midfoot Plating System Acumed is an industry leader in innovative solutions for extremities and trauma. We are dedicated to pioneering solutions
More informationALLOPURE. Bicortical Allograft Wedges Specific for Evans and Cotton Osteotomies SURGICAL TECHNIQUE
ALLOPURE Bicortical Allograft Wedges Specific for Evans and Cotton Osteotomies SURGICAL TECHNIQUE Contents Chapter 1 4 Chapter 2 5 5 5 Chapter 3 6 6 7 8 8 Appendix A 9 Introduction Intended Use Indications
More informationMarch 19, Dear Ms. Strohkirch:
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service March 19, 2015 Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66-G609 Silver Spring, MD 20993-0002 Treace
More informationTechnique Guide Lapidus Arthrodesis System
Technique Guide Lapidus Arthrodesis System HVA Angle IMA Angle The AlignMate Lapidus Arthrodesis System features low-profile, anatomically pre-contoured Bone Plates with either a combination of locking
More informationLateral TTC Plate SURGICAL TECHNIQUE
MAXLOCK EXTREME Lateral TTC Plate SURGICAL TECHNIQUE Contents Overview 2 Exposure 3 Surgical Technique 4 Implants and Instruments 10 11 Proper surgical procedures and techniques are the responsibility
More informationLOWER EXTREMITIES SINGLE-USE INSTRUMENTATION SURGICAL IMPLANTATION TECHNIQUE. First Metatarsal Phalangeal Joint FOOT THE DIFFERENCE IS MOVING.
LOWER EXTREMITIES SINGLE-USE INSTRUMENTATION SURGICAL IMPLANTATION TECHNIQUE First Metatarsal Phalangeal Joint FOOT THE DIFFERENCE IS MOVING. CARTIVA SYNTHETIC CARTILAGE IMPLANT SURGICAL IMPLANTATION TECHNIQUE
More informationThe Flower Forefoot PROCEDURE GUIDE.
The Flower Forefoot PROCEDURE GUIDE www.flowerortho.com The Flower Foot & Ankle Application NC FUSION PLATE 2-HOLE COMPRESSION PLATE TMT FUSION PLATE LAPIDUS FUSION PLATE COMPRESSION T-PLATE, OBLIQUE MTP
More informationORTHOLOC Calcaneal Fracture System SURGIC AL TECHNIQUE
ORTHOLOC Calcaneal Fracture System SURGIC AL TECHNIQUE Contents Chapter 1 4 Chapter 2 5 Chapter 3 6 7 8 9 Appendix 1 10-12 ORTHOLOC Calcaneal Fracture System - Introduction - ORTHOLOC Polyaxial Locking
More informationType of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
K153531 Page 1 of 2 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last
More informationLapidus Arthrodesis System Instructions for Use
Lapidus Arthrodesis System Instructions for Use Description The AlignMATE Lapidus Arthrodesis System consists of bone plates and bone screws (locking, non-locking and interfragmentary), which are intended
More informationNeoFit. Metatarsophal angeal Arthrodesis Pl ate
NeoFit Metatarsophal angeal Arthrodesis Pl ate 2 NEOFIT - TABLE OF CONTENTS PRODUCT DESCRIPTION 3 INDICATIONS 6 Download «PRINT» version (white background) SURGICAL TECHNIQUE 7 1 - Incision 8 2 - Preparation
More informationSurgical Technique. CONQUEST FN Femoral Neck Fracture System
Surgical Technique CONQUEST FN Femoral Neck Fracture System Table of Contents Introduction... 3 Indications... 3 Product Overview... 4 Surgical Technique... 5 Patient Positioning... 5 Reduce the Fracture...
More informationUNITE Foot Plating System
FOOT & ANKLE INTELLIGENTLY DESIGNED. 1 MEDLINE MEDLINEUNITE Foot Plating System Clinically Advanced. Optimal Functionality. Intuitive Instrumentation. Medline Unite Foot Plating System INTELLIGENT DESIGN.
More informationInCoreTM Lapidus System
InCoreTM Lapidus System Precision Guided Correction Surgical Technique InCore TM Lapidus System Precision Guided Correction Tri-Planar Correction Targeting Guide is intended to aid and stabilize angular/rotational
More informationMerete BLP. Surgical Technique. - Bunion Locking Plate - Low Profile Locking Bone Plate System
Merete BLP - Bunion Locking Plate - Low Profile Locking Bone Plate System Surgical Technique Merete Medical, Inc. 49 Purchase Street Rye, N.Y. 10580 Phone: 914 967-1532 www.merete-medical.com - Surgical
More informationCorrection System. Surgical Technique
Re+Line Bunion Correction System Surgical Technique Bunion Correction System Easy insertion and medial placement accuracy using Landmark Guide technology 1 mm compression slot and fixed tines to encourage
More informationINVISION Total Ankle Replacement System with PROPHECY Preoperative Navigation Revision of a Failed Agility Total Ankle Replacement
016625 REVISION R INVISION Total Ankle Replacement System with PROPHECY Preoperative Navigation Revision of a Failed Agility Total Ankle Replacement CASE STUDY Patient History The patient was a 65-year-old
More informationMPJ Implant System. Patents Pending Worldwide
MPJ Implant System Patents Pending Worldwide OVERVIEW ACTIVE STABILIZATION The DynaFORCE Active Stabilization System is the first to offer a hybrid implant system designed to address the most common rearfoot,
More informationORTHOLOC Calcaneal Fracture System SURGICAL TECHNIQUE
ORTHOLOC Calcaneal Fracture System SURGICAL TECHNIQUE ORTHOLOC Calcaneal Fracture System SURGICAL TECHNIQUE Contents Chapter 1 4 Chapter 2 5 Chapter 3 6 7 8 9 Appendix 1 10-12 ORTHOLOC Calcaneal Fracture
More informationMerete PlantarMAX Lapidus Plate Surgical Technique. Description of Plate
Merete PlantarMAX Lapidus Plate Surgical Technique Description of Plate Merete Medical has designed the PlantarMax; a special Plantar/Medial Locking Lapidus plate which places the plate in the most biomechanically
More informationThe American Academy of Foot & Ankle Osteosynthesis. presents
The American Academy of Foot & Ankle Osteosynthesis presents Comprehensive Course of Internal Fixation for Reconstructive Surgery and Trauma of the Foot & Ankle September 4-6, 2014 Goodlett Farms Innovation
More informationMetaFix Ludloff Plate
Merete MetaFix Ludloff Plate Low Profile Locking Bone Plate System Surgical Technique and Ordering Information - Content - Content 1. Description.................................................. 3 2.
More informationLoCKING FOREFOOT/ MIDFOOT PLATES
LoCKING FOREFOOT/ MIDFOOT PLATES LoCKING FOREFOOT/ MIDFOOT PLATES Since 1988 Acumed has been designing solutions to the demanding situations facing orthopedic surgeons, hospitals and their patients. Our
More informationHammerFUZE HAMMERTOE COMPRESSION SYSTEM SURGICAL TECHNIQUE
HammerFUZE HAMMERTOE COMPRESSION SYSTEM SURGICAL TECHNIQUE HammerFUZE HAMMERTOE COMPRESSION SYSTEM SURGICAL TECHNIQUE Design Rationale The HammerFUZE Hammertoe Compression System was designed to simplify
More informationGRAVITY Plantar Plate Repair System SURGIC AL TECHNIQUE
GRAVITY Plantar Plate Repair System SURGIC AL TECHNIQUE Contents PREFACE Preface 4 4 5 5 Chapter 1 6 6 7 8 9 11 12 13 13 Appendix 14 Introduction Positioning Indications Contraindications Surgical Technique
More informationMSP TM Metatarsal Shortening System. Surgical Technique
MSP TM Metatarsal Shortening System Surgical Technique Metaphyseal/Diaphyseal osteotomy does not result in plantar displacement of metatarsal head Osteotomy guide integrated into implant allows for controlled
More informationIntegra. surgical technique. Advansys Midfoot Plating System. eng. D.L.P. Dorsal Lisfranc Plate. M.L.P. Medial Lisfranc Plate
eng Integra Advansys Midfoot Plating System surgical technique D.L.P. Dorsal Lisfranc Plate M.L.P. Medial Lisfranc Plate Table of Contents Advansys Medial Lisfranc Plate (DLP)... 4 Indications... 4 Contraindications...
More informationIntegra. Solustaple Standard staple SURGICAL TECHNIQUE. Uni-Clip Compression staple. Products for sale in Europe, Middle-East and Africa only.
eng Integra Solustaple Standard staple SURGICAL TECHNIQUE Uni-Clip Compression staple Table of Contents Solustaple Standard staple...04 Implants Details...04 Indications...04 Instruments Details...04 Surgical
More informationMedincenter GlavUpDK by the Ministry of Foreign Affairs of Russia, Moscow.
Medincenter GlavUpDK by the Ministry of Foreign Affairs of Russia, Moscow. Berezhnoy Sergey. Percutaneous First Metatarsocuneiform Joint Arthrodesis in a Treatment of Metatarsus Primus Varus: a Prospective
More informationPL ATING SYSTEM. Pre-contoured implants Versatile fixation system Hexalobe screw recess design Locked fixation
I N N O VA T I O N ME A NS M OT I O N FOOTMOTION PL ATING SYSTEM Pre-contoured implants Versatile fixation system Hexalobe screw recess design Locked fixation FOOTMOTION PLATING SYSTEM Indications: The
More informationFoot & Ankle. EasyClip. Osteosynthesis Compression Staples. Foot & Ankle
Foot & Ankle EasyClip Osteosynthesis Compression Staples Foot & Ankle Operative Technique EasyClip Osteosynthesis Compression Staples 2 This publication sets forth detailed recommended procedures for using
More informationDRACO FOOT & ANKLE SYSTEM PRODUCT INFORMATION
DRACO FOOT & ANKLE SYSTEM PRODUCT INFORMATION 2 DRACO FOOT & ANKLE SYSTEM www.hnmtotal.com DRACO Foot & Ankle System CONTENTS MetaFuse L Plate 3 MetaFuse BLP Plate 4 MetaFuse Midfoot/Lisfranc Plate 5 MetaFuse
More informationFlower Medium Headless & Cannulated Screws
Flower Medium Headless & Cannulated Screws PROCEDURE GUIDE www.flowerortho.com The Flower Foot & Ankle Application NC FUSION PLATE 2-HOLE COMPRESSION PLATE TMT FUSION PLATE LAPIDUS FUSION PLATE COMPRESSION
More informationFoot Plating System Product rationale
Product rationale CONTENTS Introduction 2 Foot plating system 2.7mm Universal Locking Plate 2.7mm 3 Metatarsophalangeal Plate 4 Opening Wedge Locking Plate 5 Opening Wedge Osteotomy Plate 5 Foot plating
More informationThe American Academy of Foot & Ankle Osteosynthesis. presents
The American Academy of Foot & Ankle Osteosynthesis presents Comprehensive Course of Internal Fixation for Reconstructive Surgery and Trauma of the Foot & Ankle Hyatt DFW Airport Dallas, Texas SCIENTIFIC
More informationSurgical Technique. Distal Humerus Locking Plate
Surgical Technique Distal Humerus Locking Plate PERI-LOC Locked Plating System Distal Humerus Locking Plate Surgical Technique Table of Contents Introduction...2 Indications...3 Plate Features...3 Patient
More informationREPAIR OF THE DISPLACED AUSTIN OSTEOTOMY
C H A P T E R 2 1 REPAIR OF THE DISPLACED AUSTIN OSTEOTOMY John V. Vanore, DPM INTRODUCTION Bunion surgery is frequently performed by foot and ankle surgeons. Generally, bunion surgery is quite predictable,
More informationAstrid Modular Forefoot System. Surgical Technique
Astrid Modular Forefoot System Surgical Technique Table of Contents Astrid a System for Surgery of the Forefoot... Scarf Osteotomies...6 Stabilization by Means of Two Parallel Double-Threaded Screws Introduced
More informationLCP Medial Distal Tibia Plate, without Tab. The Low Profile Anatomic Fixation System with Angular Stability and Optimal Screw Orientation.
LCP Medial Distal Tibia Plate, without Tab. The Low Profile Anatomic Fixation System with Angular Stability and Optimal Screw Orientation. Technique Guide LCP Small Fragment System Table of Contents Introduction
More informationMidfoot Plating Techniques Surgical Technique
Midfoot Plating Techniques Surgical Technique Midfoot Plating Techniques Lapidus Plate Designed to provide excellent fixation for a lapidus procedure, the Lapidus Plate offers the foot & ankle surgeon
More informationBunion Correction System
Bunion Correction System Easy insertion and medial placement accuracy using Landmark Guide technology Maximized and repeatable uniform compression across osteotomy site Stable Fixation of the Metatarsal
More informationSMV Scientific Bone Plate and Screw System Surgical Technique
SMV Scientific Bone Plate and Screw System Surgical Technique Description: The SMV Scientific Bone Plate and Screw System consists of non-locking plates and bone screw fasteners in a variety of lengths,
More informationwave Calcaneal Fracture Plate
wave Calcaneal Fracture Plate s u r g i c a l t e c h n i q u e Tornier WAVE Calcaneal fracture plate system surgical procedure Indications for Use: The Tornier Calcaneal Fracture Plate System is indicated
More informationSTS. Subtalar Spacer System SURGICAL TECHNIQUE
STS Subtalar Spacer System SURGICAL TECHNIQUE Contents Chapter 1 4 Introduction 4 Device Description Chapter 2 5 Intended Use 5 Indications Chapter 3 6 Surgical Technique 9 Postoperative Protocol 9 Explant
More informationLCP Anterolateral Distal Tibia Plate 3.5. The low profile anatomic fixation system with optimal plate placement and angular stability.
LCP Anterolateral Distal Tibia Plate 3.5. The low profile anatomic fixation system with optimal plate placement and angular stability. Technique Guide LCP Small Fragment System Table of Contents Introduction
More informationSurgical Technique. Olecranon Locking Plate
Surgical Technique Olecranon Locking Plate PERI-LOC Locked Plating System Olecranon Locking Plate Surgical Techniquealog Infor Table of Contents Introduction...2 Indications...3 Plate Features...3 Patient
More informationCorrection System. Surgical Technique
Re+Line Bunion Correction System Surgical Technique Bunion Correction System Easy insertion and medial placement accuracy using Landmark Guide technology Greater and repeatable uniform compression across
More informationSURGICAL TECHNIQUE GUIDE: LAPIDUS ARTHRODESIS USING THE PHANTOM INTRAMEDULLARY NAIL INTRAMEDULLARY NAIL
LAPIDUS ARTHRODESIS USING THE PHANTOM INTRAMEDULLARY NAIL INTRAMEDULLARY NAIL LAPIDUS ARTHRODESIS USING THE PHANTOM INTRAMEDULLARY NAIL Acknowledgment: Paragon 28 would like to thank James T. Clancy, DPM
More informationIntegra. DigiFuse Cannulated Intramedullary Fusion System SURGICAL TECHNIQUE
Integra DigiFuse Cannulated Intramedullary Fusion System SURGICAL TECHNIQUE Table of Contents Design Rationale... 2 System Features... 2 Indications... 2 Contraindications... 2 Surgical Technique...3 Step
More informationTORNIER BIO-RSA. Bony Increased Offset - Reversed Shoulder Arthroplasty SURGICAL TECHNIQUE
TORNIER BIO-RSA Bony Increased Offset - Reversed Shoulder Arthroplasty SURGICAL TECHNIQUE 2 Table of Contents: Concept...4 Bony Increased Offset Reversed Shoulder Arthroplasty (BIO-RSA ) Concept...4 Surgical
More informationBLUEPRINT. 3D Planning + PSI SURGIC AL TECHNIQUE
TO R N I E R BLUEPRINT 3D Planning + PSI SURGIC AL TECHNIQUE V 1. 5. 3 P O LYA M I D E Contents 4 5 6 7 9 Patient Specific Instrumentation Overview 3D Planning PSI Guide Creation and Order Use of PSI
More informationVariAx 2 Plating Solutions
VariAx 2 Plating Solutions Operative technique VariAx 2 Foot Stryker Foot Plating System VariAx 2 Plating Solutions Table of contents Indications, precaution, and contraindications VariAx 2 Foot - tray
More informationLCP Anterolateral Distal Tibia Plate 3.5. The low profile anatomic fixation system with optimal plate placement and angular stability.
LCP Anterolateral Distal Tibia Plate 3.5. The low profile anatomic fixation system with optimal plate placement and angular stability. Technique Guide LCP Small Fragment System Table of Contents Introduction
More informationSurgical Technique. Clavicle Locking Plate
Surgical Technique Clavicle Locking Plate PERI-LOC Locked Plating System Clavicle Locking Plate Surgical Technique Table of Contents Introduction...2 Indications...3 Plate Features...3 Patient Positioning...4
More informationUse of the 20 Memory Staple in Osteotomies of Fusions of the Forefoot
168 Forefoot Reconstruction Use of the 20 Memory Staple in Osteotomies of Fusions of the Forefoot Definition, History, Generalities This staple first provides a permanent compression both in the prongs
More informationWright Medical Technology, Inc Cherry Road Memphis, TN
Wright Medical Technology, Inc. 1023 Cherry Road Memphis, TN 38117 800 238 7117 901 867 9971 www.wmt.com Wright Medical EMEA Atlas Arena, Australia Building Hoogoorddreef 7 1101 BA Amsterdam the Netherlands
More informationThe Flower Straight Fibula Plate
The Flower Straight Fibula Plate PROCEDURE GUIDE www.flowerortho.com The Flower Foot & Ankle Application STRAIGHT LOCKING FIBULA PLATE ANTERIOR LATERAL DISTAL TIBIAL PLATE MEDIAL DISTAL TIBIAL PLATE ANATOMIC
More informationSurgical Technique. Forearm Fracture Solutions
Surgical Technique Forearm Fracture Solutions Acumed is a global leader of innovative orthopaedic and medical solutions. We are dedicated to developing products, service methods, and approaches that improve
More informationTechnique Guide. 3.5 mm LCP Low Bend Medial Distal Tibia Plates. Part of the Synthes locking compression plate (LCP) system.
Technique Guide 3.5 mm LCP Low Bend Medial Distal Tibia Plates. Part of the Synthes locking compression plate (LCP) system. Table of Contents Introduction 3.5 mm LCP Low Bend Medial Distal Tibia Plates
More informationBLUEPRINT. 3D Planning + PSI SURGIC AL TECHNIQUE V 2.1 T I TA N I U M
TO R N I E R BLUEPRINT 3D Planning + PSI SURGIC AL TECHNIQUE V 2.1 T I TA N I U M Contents 4 5 6 7 9 Patient-Specific Instrumentation Overview 3D Planning PSI Guide Creation and Order Use of PSI Guide
More informationSurgical Technique. Anterolateral and Medial Distal Tibia Locking Plates
Surgical Technique Anterolateral and Medial Distal Tibia Locking Plates PERI-LOC Periarticular Locked Plating System Anterolateral and Medial Distal Tibia Locking Plates Surgical Technique Contents Product
More informationTORNIER LATITUDE EV. Total Elbow Arthroplasty
TORNIER LATITUDE EV Total Elbow Arthroplasty LATITUDE EV TOTAL ELBOW ARTHROPLASTY Welcome to the EVOLUTION of elbow replacement The LATITUDE EV total elbow arthroplasty system is designed to replicate
More informationContents. Design Rationale Surgical Goals System Basics
Contents Preface 3 Chapter 1 4 4 4 Chapter 2 5 5 6 8 10 Chapter 3 11 Appendix A 12 Appendix B 13 Appendix C 14-15 Introduction Design Rationale Surgical Goals System Basics CHARLOTTE CAROLINA Jones Surgical
More informationLCP Anterior Ankle Arthrodesis Plates. Part of the Synthes Locking Compression Plate (LCP) System.
LCP Anterior Ankle Arthrodesis Plates. Part of the Synthes Locking Compression Plate (LCP) System. Technique Guide Instruments and implants approved by the AO Foundation Table of Contents Introduction
More information