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US Product Portfolio for Small Bone and Joint Orthopedic Devices 2017 - MedFolio

US Product Portfolio for Small Bone and Joint Orthopedic Devices 2017 - MedFolio

Joint implants include a wide range of prosthesis made of metal, plastic, ceramic or even biological materials. These devices are used in an arthroplasty, or joint reconstruction procedure, a removal of the diseased joint and replacing it with a prosthetic device. Arthroplasty was invented by the British orthopedic surgeon Sir John Charnley, who pioneered the technique in hip replacement in November 1962. He was knighted in recognition for this and other work in orthopedics in 1977. When a joint is replaced for the first time, it is referred to as a primary replacement. Primary replacements are either total joint replacements or partial joint replacements. Total joint implants replace both sides of a joint, whereas partial replacement implants only replace one side and conserve the other. Replacing a worn implant with another implant is referred to as a revision procedure. External and internal fixation devices are usually mentioned under the joint specified type, but also may be separated into independent categories. These devices include not only joint fixation products but also bone fixation devices (e.g. intramedullary nails, indicated for fractures of long bones), which is not a particular subject of the joint reconstruction market. Staple fixation devices are also used for internal fixation and usually are not specified by joint type, but vary in sizes, so they may be used for different joints and bones. Plates and screws are fixation devices mostly indicated for fractures. These devices are similar for all types of joints. These devices are usually included in a joint specific category in a company’s portfolio, but also may be separated into Plates and Screws. Plates and screws vary in sizes, materials and shapes depending on which area of the skeleton requires fixation. Devices may be used in different areas of the body, including joints, forearm, pelvic and jaw. Plates are attached to the bone with screws to provide bone healing process. Plates may be left in place after healing is completed or may be removed, depending on a particular case.

The small joint market includes medical devices for restoring and reconstructing the elbow, foot and ankle, hand and wrist and shoulder, as well as staple fixation devices. Based on the portfolios of most orthopedic device companies, the joint reconstruction market is usually segmented by joint type, e.g. DePuy’s portfolio is divided into Shoulder, Knee, Hip reconstruction devices, as well as Spine and also includes categories for various devices (implants, plates, biomaterials and others) that may be used for different joints, such as Sport Medicine, Trauma, Biologics and others. Zimmer Biomet, Stryker, Integra LifeScience, Acumed and others mostly use a similar structure. In some cases, a company may separate joint devices into upper and lower extremity reconstruction, including shoulder, elbow and wrist in one category and hip, knee and ankle in another.


EXECUTIVE SUMMARY
U.S. SMALL BONE AND JOINT ORTHOPEDIC DEVICE MARKET OVERVIEW
COMPETITIVE ANALYSIS
MARKET TRENDS
MARKET DEVELOPMENTS
PROCEDURE NUMBERS
PROCEDURE CODES INVESTIGATED
MARKETS INCLUDED
KEY REPORT UPDATES
VERSION HISTORY
RESEARCH METHODOLOGY
1.1 RESEARCH SCOPE
1.2 IDATA’S 9-STEP METHODOLOGY
Step 1: Project Initiation & Team Selection
Step 2: Prepare Data Systems and Perform Secondary Research
Step 3: Preparation for Interviews & Questionnaire Design
Step 4: Performing Primary Research
Step 5: Research Analysis: Establishing Baseline Estimates
Step 6: Market Forecast and Analysis
Step 7: Identify Strategic Opportunities
Step 8: Final Review and Market Release
Step 9: Customer Feedback and Market Monitoring
DISEASE OVERVIEW
2.1 BASIC ANATOMY
2.1.11 Elbow
2.1.12 Foot and Ankle
2.1.13 Hand and Wrist
2.1.14 Shoulder
2.2 DISEASE TREATMENTS AND DIAGNOSTICS
2.2.1 Arthritis
2.2.2 Osteoarthritis
2.2.3 Traumatic Injuries
2.2.4 Avascular Necrosis
2.2.5 Congenital Bone Disorder
2.3 PATIENT DEMOGRAPHICS
2.3.1 General Statistics
2.3.2 Osteoporosis Incidence
2.3.3 Arthritis Incidence
PRODUCT ASSESSMENT
3.1 PRODUCT PORTFOLIOS
3.1.1 Elbow Reconstruction Device Market
3.1.2 Foot and Ankle Device Market
3.1.3 Hand and Wrist Device Market
3.1.4 Shoulder Reconstruction Device Market
3.1.5 Staple Fixation Market
3.1.6 Latest Developments in Joint Reconstruction
3.2 REGULATORY ISSUES AND RECALLS
3.2.1 Acumed
3.2.1.1 Plates and screws
3.2.2 Arthrosurface
3.2.2.1 Various small joint Implants and related tools
3.2.3 DePuy
3.2.3.1 Elbow
3.2.3.2 Hand and Wrist
3.2.3.3 Plates and screws
3.2.3.4 Various small joint Implants and related tools
3.2.4 Exatech
3.2.4.1 Various small joint Implants and related tools
3.2.5 Integra LifeScience
3.2.5.1 Foot and Ankle
3.2.5.2 Plates and screws
3.2.5.3 Various small joint Implants and related tools
3.2.6 Lima Corporate
3.2.6.1 Shoulder
3.2.9 Smith and Nephew
3.2.9.1 Plates and screws
3.2.10 Stryker
3.2.10.1 Elbow
3.2.10.2 Various fixation devices
3.2.10.3 Various small joint Implants and related tools
3.2.11 Wright Medical
3.2.11.1 Foot and Ankle
3.2.11.2 Plates and screws
3.2.12 Zimmer Biomet
3.2.12.1 Elbow
3.2.12.2 Foot and Ankle
3.2.12.4 Plates and screws
3.2.12.5 Shoulder
3.2.12.6 Various fixation devices
3.2.12.7 Various small joint Implants and related tools
3.2.13 Other companies
3.2.13.1 Elbow
3.2.13.2 Foot and Ankle
3.2.13.3 Hand and Wrist
3.2.13.4 Plates and screws
3.3 CLINICAL TRIALS
3.3.1 Arthrex
3.3.1.1 Foot and Ankle
3.3.1.2 Plates and Screws
3.3.1.3 Shoulder
3.3.2 DePuy Synthes
3.3.2.1 Plates and Screws
3.3.2.2 Shoulder
3.3.3 Integra LifeScience
3.3.3.1 Foot and Ankle
3.3.3.2 Staples Fixation
3.3.3.3 Hand and Wrist
3.3.3.4 Plates and Screws
3.3.3.5 Shoulder
3.3.4 Smith and Nephew
3.3.4.1 Shoulder
3.3.5 Stryker
3.3.5.1 Shoulder
3.3.6 Zimmer Biomet
3.3.6.1 Elbow
3.3.6.2 Foot and Ankle
3.3.6.3 Plates and Screws
3.3.6.4 Shoulder
3.3.7 Wright Medical
3.3.7.1 Foot and Ankle
3.3.7.2 Shoulder
3.3.8 Other companies
3.3.8.1 Elbow
3.3.8.2 Foot and Ankle
3.3.8.3 Plates and Screws
3.3.8.4 Hand and Wrist
3.3.8.5 Plates and screws
ABBREVIATIONS
APPENDIX: COMPANY PRESS RELEASES
List of Charts
Chart 1 1: Small Bone and Joint Orthopedic Device Market by Segment, U.S., 2013 – 2023
Chart 1 2: Small Bone and Joint Orthopedic Device Market Overview, U.S., 2016 & 2023
List of Figures
Figure 1 1: Small Bone and Joint Orthopedic Device Market Share Ranking by Segment, U.S., 2016 (1 of 2)
Figure 1 2: Small Bone and Joint Orthopedic Device Market Share Ranking by Segment, U.S., 2016 (2 of 2)
Figure 1 3: Companies Researched in this Report, U.S., 2016
Figure 1 4: Factors Impacting the Small Bone and Joint Orthopedic Device Market by Segment, U.S.
Figure 1 5: Recent Events in the Small Bone and Joint Orthopedic Device Market, U.S., 2014 – 2016
Figure 1 6: Small Bone and Joint Orthopedic Device Procedures Covered, U.S., 2016
Figure 1 7: Procedure Codes Investigated, U.S., 2016 (1 of 2)
Figure 1 8: Procedure Codes Investigated, U.S., 2016 (2 of 2)
Figure 1 9: Small Bone and Joint Orthopedic Device Markets Covered, U.S., 2016 (1 of 2)
Figure 1 10: Small Bone and Joint Orthopedic Device Markets Covered, U.S., 2016 (2 of 2)
Figure 1 11: Key Report Updates
Figure 1 12: Version History
Figure 3 1: Elbow Reconstruction Device Market Products by Company (1 of 5)
Figure 3 2: Elbow Reconstruction Device Market Products by Company (2 of 5)
Figure 3 3: Elbow Reconstruction Device Market Products by Company (3 of 5)
Figure 3 4: Elbow Reconstruction Device Market Products by Company (4 of 5)
Figure 3 5: Elbow Reconstruction Device Market Products by Company (5 of 5)
Figure 3 6: Foot and Ankle Device Market Products by Company (1 of 10)
Figure 3 7: Foot and Ankle Device Market Products by Company (2 of 10)
Figure 3 8: Foot and Ankle Device Market Products by Company (3 of 10)
Figure 3 9: Foot and Ankle Device Market Products by Company (4 of 10)
Figure 3 10: Foot and Ankle Device Market Products by Company (5 of 10)
Figure 3 11: Foot and Ankle Device Market Products by Company (6 of 10)
Figure 3 12: Foot and Ankle Device Market Products by Company (7 of 10)
Figure 3 13: Foot and Ankle Device Market Products by Company (8 of 10)
Figure 3 14: Foot and Ankle Device Market Products by Company (9 of 10)
Figure 3 15: Foot and Ankle Device Market Products by Company (10 of 10)
Figure 3 16: Hand and Wrist Device Market Products by Company (1 of 5)
Figure 3 17: Hand and Wrist Device Market Products by Company (2 of 5)
Figure 3 18: Hand and Wrist Device Market Products by Company (3 of 5)
Figure 3 19: Hand and Wrist Device Market Products by Company (4 of 5)
Figure 3 20: Hand and Wrist Device Market Products by Company (5 of 5)
Figure 3 21: Shoulder Reconstruction Device Market Products by Company (1 of 5)
Figure 3 22: Shoulder Reconstruction Device Market Products by Company (2 of 5)
Figure 3 23: Shoulder Reconstruction Device Market Products by Company (3 of 5)
Figure 3 24: Shoulder Reconstruction Device Market Products by Company (4 of 5)
Figure 3 25: Shoulder Reconstruction Device Market Products by Company (5 of 5)
Figure 3 26: Staple Fixation Market Products by Company (1 of 2)
Figure 3 27: Staple Fixation Market Products by Company (2 of 2)
Figure 3 28: Class 2 Device Recall Acumed Tension Band Pin
Figure 3 29: Class 2 Device Recall The HemiCAP Contoured Articular Prosthetic
Figure 3 30: Class 2 Device Recall Synthes Radial Head Prosthesis System
Figure 3 31: Class 2 Device Recall Synthes Radial Head Prosthesis: Trial Radial Head
Figure 3 32: Class 2 Device Recall Synthes LCP DiaphysealMetaphyseal Volar Distal Radius Plate
Figure 3 33: Class 2 Device Recall Synthes Variable Angle LCP Dorsal Distal Radius System
Figure 3 34: Class 2 Device Recall Synthes 2.4mm Titanium Locking Screws SelfTapping with Stardrive Recess 12mm
Figure 3 35: Class 2 Device Recall 4.0 mm Cortex Screw
Figure 3 36: Class 2 Device Recall Synthes Titanium Small Reconstruction Plate
Figure 3 37: Class 2 Device Recall 2.7 MM Locking Screw SLFTPNG with T8 Stardrive Recess 12MM
Figure 3 38: Class 2 Device Recall Orthopedic Devices
Figure 3 39: Class 2 Device Recall Synthes 2.7mm LCP Ulna Osteotomy System
Figure 3 40: Class 2 Device Recall Synthes 2.4 mm LCDCP Plate 6 Holes/51mm
Figure 3 41: Class 2 Device Recall Synthes Midfoot Fusion Bolt
Figure 3 42: Class 2 Device Recall Synthes Trauma ExFix System
Figure 3 43: Class 2 Device Recall Glenosphere Orientation Guide for the Delta XTEND Reverse Shoulder System
Figure 3 44: Class 2 Device Recall Torque Defining Screw and Screwdriver
Figure 3 45: Class 2 Device Recall Equinoxe
Figure 3 46: Class 2 Device Recall Integra Cadence Total Ankle System
Figure 3 47: Class 2 Device Recall Cadence Size 5 Left Tibial Tray Implant
Figure 3 48: Class 2 Device Recall SURFIX Fixed Angle Locking Screw
Figure 3 49: Class 2 Device Recall TS Series Depth Gauge for Integra Ti6 Internal Fixation System 2.0/2.5mm Screws
Figure 3 50: Class 2 Device Recall Integra Titan Reverse Shoulder System
Figure 3 51: Class 2 Device Recall Surgical Instrument for SMR Anatomic and Reverse Shoulder Prosthesis
Figure 3 52: Class 2 Device Recall SMR glenosphere impactor/extractor
Figure 3 53: Class 2 Device Recall Trial Humeral Head
Figure 3 54: Class 2 Device Recall Trial Adaptor Head
Figure 3 55: Unclassified Correction or Removal Periloc Volar Distal Radius right 3h std head locking plate
Figure 3 56: Class 2 Device Recall PeriLoc(R) VLP 3.5 mm x 6 mm selftapping cortex screw
Figure 3 57: Class 2 Device Recall Small Bone Innovations (see also Product Description), SBi
Figure 3 58: Class 2 Device Recall Stryker Howmedica Osteonics
Figure 3 59: Class 2 Device Recall Stryker T2 Supracondylar Nail System
Figure 3 60: Class 2 Device Recall Osteonics Shoulder Glenoid Spanner
Figure 3 61: Class 2 Device Recall Salto Talaris Tibial Guide
Figure 3 62: Class 2 Device Recall CrossCHECK Locking Screw
Figure 3 63: Class 2 Device Recall CROSSCHECK(R) plating system
Figure 3 64: Class 2 Device Recall Claw(R) II straight plate Ortholoc(tm)
Figure 3 65: Class 2 Device Recall Coonrad/ Morrey Elbow Pin/ Bushing Replacement size Kit Extra Small
Figure 3 66: Class 2 Device Recall Elbow Humeral Trial
Figure 3 67: Class 2 Device Recall Discovery Elbow (since 2015 – DJO)
Figure 3 68: Class 2 Device Recall ExploR 7x26mm Modular Radial Stem
Figure 3 69: Class 2 Device Recall Construx Alum Ankle Clamp
Figure 3 70: Class 2 Device Recall Zimmer Trabecular Metal Total Ankle Tibial Base and Talar Components
Figure 3 71: Class 2 Device Recall Smith & Nephew Periloc Volar Distal Radius Plate Standard 3 Hole
Figure 3 72: Class 2 Device Recall Biomet Inc., Biomet Sports Medicine, and Biomet
Figure 3 73: Class 2 Device Recall DVR ePAK
Figure 3 74: Class 2 Device Recall Zimmer
Figure 3 75: Class 2 Device Recall Zimmer Universal Locking System
Figure 3 76: Class 2 Device Recall Biomet A.L.P.S. 4.0mm Cancellous Locking Screws
Figure 3 77: Class 2 Device Recall A.L.P.S
Figure 3 78: Class 2 Device Recall low profile Nonlock screw
Figure 3 79: Class 2 Device Recall Trauma Tubes and Plates
Figure 3 80: Class 2 Device Recall Zimmer Periarticular Locking Plate System
Figure 3 81: Class 2 Device Recall Distal Radius Fracture Repair System
Figure 3 82: Class 1 Device Recall Biomet Comprehensive Reverse Shoulder Humeral
Figure 3 83: Class 2 Device Recall Anatomical Shoulder Domelock
Figure 3 84: Class 3 Device Recall BIOMET Comprehensive Shoulder System
Figure 3 85: Class 2 Device Recall Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor
Figure 3 86: Class 2 Device Recall Trabecular Metal
Figure 3 87: Class 2 Device Recall Bigliani/Flatow Complete Shoulder Solution
Figure 3 88: Class 2 Device Recall Zimmer Anatomical Shoulder
Figure 3 89: Class 2 Device Recall Trabecular Metal Reverse Shoulder Liner 40mm
Figure 3 90: Class 2 Device Recall Biomet Inc., Biomet Sports Medicine, and Biomet
Figure 3 91: Unclassified Correction or Removal Fem and Tibial IM Nail
Figure 3 92: Class 2 Device Recall various polyethylene implants
Figure 3 93: Class 2 Device Recall Align Radial Stem, Skeletal Dynamics
Figure 3 94: Class 2 Device Recall ExploR 7x26mm Modular Radial Stem, Skeletal Dynamics
Figure 3 95: Class 2 Device Recall Vilex, Inc., FUZE 10.0 mm x 200 mm, Product FZ100200T25, Vilex Inc.
Figure 3 96: Class 2 Device Recall DRP Screw, In2Bones, SAS
Figure 3 97: Class 2 Device Recall TriMed SemiTubular Plate, Trimed Inc.
Figure 3 98: Class 2 Device Recall 7, 9, and 11Hole VL Gridlock Fibula Plating System, Trilliant Surgical Ltd.
Figure 3 99: Class 2 Device Recall Gridlock Screw Driver Bit, Trilliant Surgical Ltd.
Figure 3 100: Class 2 Device Recall Orthopediatrics PediLoc Tibial Plate System, OrthoPediatrics Corp
Figure 3 101: Static Implant Versus Dynamic Implant in the Surgical Treatment on Ankle Syndesmosis Rupture
Figure 3 102: TMT Fusion Plate vs. Two Crossed Screws (TMT)
Figure 3 103: Humeral Head Implants: Radiological and Clinical Evaluation
Figure 3 104: Plate Fixation of Distal Femur Fractures: A Protocol for a Study of Two Plate Options
Figure 3 105: Effectiveness of Hemi- Versus Total Shoulder Arthroplasty Using Implants of the Epoca System (Epoca H vs T)
Figure 3 106: Long-term Clinical Effectiveness of the Delta Xtend Reverse Total Shoulder
Figure 3 107: DePuy Global Unite Shoulder System
Figure 3 108: Ankle Joint Replacement Outcomes Study
Figure 3 109: Short Term Follow-up of Patient Implanted With the Metatarso-Phalangeal Prosthesis METIS®
Figure 3 110: Short Term Follow-up of Patient Implanted With the Proximal Interphalangeal Implant
Figure 3 111: Follow-up of Patient Implanted With the Staple ASTUS®
Figure 3 112: Ascension® Post- Approval Study; PyroCarbon Metacarpophalangeal Total Joint Prosthesis (MCP)
Figure 3 113: Short Term Follow-up of Patient Implanted With the Proximal Interphalangeal Implant
Figure 3 114: Short Term Follow-up of Patent Implanted With the B-BOP Lock Plate
Figure 3 115: TITAN™ Reverse Shoulder System
Figure 3 116: A Multi-center Outcomes Clinical Study of the PyroTITAN™ HRA Shoulder Implant in Humeral Head Resurfacing (CHRA)
Figure 3 117: A Comparison Between a Pyrocarbon and a CoCr Shoulder Resurfacing Implant
Figure 3 118: Ascension® Humeral Resurfacing Arthroplasty Follow-Up Study
Figure 3 119: Patient Benefit From the New Modular Shoulder Prosthesis PROMOS (Promos)
Figure 3 120: Multicenter Clinical Observation PROMOS®
Figure 3 121: Comparing The Outcome of Large-Diameter vs Small-Diameter Glenospheres in Primary Reverse Shoulder Arthroplasty
Figure 3 122: ExploR™ Modular Radial Head Data Collection
Figure 3 123: Zimmer Trabecular Metal Total Ankle
Figure 3 124: Zimmer® MotionLoc® in Distal Tibia Fractures
Figure 3 125: Sidus(TM) Post Market Clinical Follow-up (PMCF) Study
Figure 3 126: Clinical Experience With the Zimmer Trabecular Metal (TM) Glenoid in Total Shoulder Arthroplasty (TMGlenoid)
Figure 3 127: UK Infinity, Post-Market Clinical Follow-up Study
Figure 3 128: Aequalis Resurfacing Head Study
Figure 3 129: Clinical Outcomes in Shoulder Hemi-arthroplasty Using a PyC Spherical Interpositional Implant
Figure 3 130: Safety and Effectiveness of the Tornier Simpliciti™ Shoulder System in Shoulder Arthroplasty
Figure 3 131: Multi-Center Trial to Evaluate an Internal Joint Stabilizer - Elbow
Figure 3 132: Comparing Ankle Fusion to Ankle Replacement
Figure 3 133: Agili-CTM Implant Performance Evaluation in the Treatment of Osteoarthritis of the Great Toe
Figure 3 134: Post Approval Study to Evaluate the Effectiveness and Safety of Cartiva Implant in the Treatment of OA of the Great Toe
Figure 3 135: Evaluation of CyclaPlex Implant for Correction of First Inter Metatarsal Angle in Subjects Suffering From Hallux Valgus Deformity
Figure 3 136: Buried Intramedullary K-wire Fixation Compared With Plate and Screw Fixation in Unstable Extra-Articular Metacarpal Fractures
Figure 3 137: Fibular Fixation in Ankle Fractures:Plate Verses Nail.
Figure 3 138: A Prospective Randomized Pilot Study to Compare Open Versus Percutaneous Syndesmosis Repair of Unstable Ankle Fractures
Figure 3 139: Comparing Stability and Cost-Effectiveness of 3 Bicortical Screws Vs Adjustable Plate and 2 Bicortical Screws in Fixation of BSSRO
Figure 3 140: Motec Versus Remotion Total Wrist Arthroplasty - A Prospective Study
Figure 3 141: Patient Perceived Outcome After Total Wrist Arthroplasty With a New Total Wrist Arthroplasty Implant
Figure 3 142: Comparison of Three Fixation Techniques for Displaced Distal Radius Fractures (DRF)
Figure 3 143: Plate Fixation of Distal Femur Fractures: A Protocol for a Study of Two Plate Options
Figure 3 144: Lateral Mini Approach vs Anterior Approach for Plating of Proximal Humerus Fracture (HURA)
Figure 5 1: Press Release Summary

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