Orthopedics Markets

  • February 2011
  • -
  • TriMark Publications
  • -
  • 283 pages

Orthopedics is a medical specialty that deals with the diagnosis and treatment of disorders and injuries to the skeletal system and the muscles, joints and ligaments associated with it. The orthopedics market has emerged as one of the most vibrant industries in the medical equipment sector. In the recent past, the orthopedics industry has witnessed major private equity transactions, several notable mergers and innovative product launches. As such, the orthopedics market has been experiencing a growth rate of nearly 5% to 7% annually. Five market leaders currently dominate the global market, each with about $2 billion or more in annual sales. The purpose of this TriMark Publications report is to provide a detailed analysis of the global market for orthopedics.
The product segments covered in study include: reconstructive devices, fracture repair, arthroscopy/tissue repair, spinal implants/instrumentation, orthobiologics and other orthopedic products. The study analyzes almost all of the companies known to be marketing, manufacturing or developing orthopedic products in the U.S. and worldwide. Each company is discussed in depth, with a section on its history, product line, business and marketing analysis, and a subjective commentary of the company's market position. Also provided in this review are detailed tables, charts and figures with past and projected sales data by geographic region for the U.S., EMEA (Europe, Middle East, Africa), Japan, the Pacific Rim, Canada and Latin America.

Table Of Contents

TABLE OF CONTENTS

1. Overview 16
1.1 Statement of Report 16
1.2 Scope of the Report 17
1.3 Methodology 18
1.4 Executive Summary 19
2. Overview of Selected Orthopedic Surgical Procedures and Products 21
2.1 Scope of this Chapter 21
2.2 Surgery for Hip Implants 21
2.2.1 Cemented Hip Implants 21
2.2.2 Porous Hip Implants 21
2.2.3 Preparing for Hip Implant Surgery 21
2.2.4 Hip Implant Surgery 22
2.2.5 Market Leaders in Hip and Knee Implants 23
2.2.6 Benefits of Hip and Knee Replacement 24
2.2.7 Most Common Hip Disorders 24
2.2.8 Total Hip Arthroplasty at the Global Level 25
2.3 Surgery for Knee Implants 26
2.3.1 Gender-Specific Knee 27
2.3.2 Viscosupplementation for the Osteoarthritis of the Knee 28
2.3.3 Synovial Injections and Efficacy 28
2.3.4 Market Leaders in Knee Products 29
2.3.5 Pricing Trends in Hip and Knee Implants 31
2.3.5.1 Total Hips 34
2.3.5.2 Partial Hips 37
2.3.6 Knee Implants 39
2.4 Shoulder Implants 43
2.4.1 Reverse Shoulder Replacement 44
2.4.2 Total Shoulder Replacement 45
2.4.3 Rotator Cuff Repair 46
2.5 Spine Anatomy 46
2.5.1 Spine Disorders 47
2.5.2 Spinal Implants 47
2.5.3 Spinal Fusion Surgery 47
2.5.4 Spinal Stabilization 48
2.5.5 Common Indications for Spinal Surgery in the Elderly 48
2.5.6 Average Reimbursement by Spinal Indication 49
2.5.7 Medicare Reimbursements and Treatment Alternatives 49
2.5.8 Lumbar Spine Fusion: Providers and Reimbursement in the U.S. 50
2.5.9 Balloon Kyphoplasty 50
2.5.10 Elderly Spine Patients 51
2.5.11 Lumbar and Cervical Total Disc Replacement 52
2.5.12 Indications for Total Disc Replacement 52
2.5.13 Percutaneous Procedures 54
2.5.14 Niche Markets in Spine 56
2.5.15 Complication Rates in Posterior Lumbar Fusion 56
2.6 Foot and Ankle 58
2.6.1 Ankle Fusion and Ankle Replacement 59
2.6.2 Deformities of Toes 60
2.6.3 Plantar Fascial Fibromatosis 62
2.6.4 Bunion 63
2.7 Finger Disorders 64
2.7.1 Carpal Tunnel Syndrome 64
2.8 Tennis Elbow 65
2.9 Trauma in Extremities 66
2.10 Arthroscopy 66
2.11 Extracorporeal Shockwave Therapy 67
2.12 Bone Graft Materials 68
2.12.1 Allograft-Based Bone Graft Substitutes 69
2.12.2 Factor-Based Bone Graft Substitutes 69
2.12.3 Cell-Based Bone Graft Substitutes 69
2.12.4 Ceramic-Based Bone Graft Substitutes 69
2.12.5 Polymer-Based Bone Graft Substitutes 70
2.13 Electrical Stimulation in Fracture Healing 70
2.14 Materials Used in Orthopedic Implants 70
2.14.1 Implant Fabrication Process 71
2.14.2 Post-Fabrication Coatings 72
2.14.3 Forces Shaping the Implant Market 72
2.14.3.1 A New Class of Materials 72
2.14.4 Future Trends in Orthopedics 73
3. Orthopedics Market Analysis 74
3.1 Scope of this Chapter 74
3.2 Orthopedics Industry 74
3.3 Market Drivers in Orthopedics 75
3.3.1 Changing Lifestyle 75
3.3.2 Aging Population 75
3.3.3 Technology Advancements 77
3.3.4 Implants as Effective Alternatives to Drug Therapy 77
3.4 Changing Focus of Medical Device Companies 77
3.5 Primacy of the Orthopedic Device Segment 78
3.6 Global Orthopedics Market 79
3.6.1 Market Leaders in Orthopedic Implants 80
3.6.2 Orthopedics Market Segment Overview 83
3.6.3 Global Orthopedics Market Leaders 84
3.6.4 Global Orthopedics Market by Geography 85
3.6.5 Future of the Global Orthopedics Market 86
3.6.6 Global Spine Market 87
3.6.6.1 Future Market for Spinal Implants 87
3.7 Global Orthopedic Reconstruction Market 88
3.7.1 Future of Orthopedic Reconstruction Market 89
3.7.2 Global Trauma and Craniomaxillofacial Market 90
3.7.3 Future of Global Trauma and Craniomaxillofacial Market 91
3.8 Global Joint Replacement Market 92
3.9 Global Market for Fracture Repair 92
3.9.1 Patient Demographics in Bone Fractures 93
3.10 Craniomaxillofacial Reconstruction 94
3.11 Global Biomedical Metal Market 95
3.12 Global Orthobiologics Market 96
3.12.1 Spinal Fusion: 75% of All Bone Grafts 96
3.12.2 Foot and Ankle Fusions 96
3.12.3 Orthopedic Trauma 96
3.12.4 Reconstruction 97
3.12.5 Biologic Solutions in Sports Medicine 97
3.12.6 Future of Global Orthobiologics Market 97
3.13 Medsurg Equipment Market 98
3.13.1 Global Endoscopy Market 99
3.14 Global Market for Non-Invasive Orthopedics 99
3.15 Funding Scenario in Orthopedics 100
3.16 Orthopedics Market in the U.S. 101
3.16.1 Reimbursement and Healthcare Costs in the U.S. 102
3.16.2 Overspending on Orthopedics in the U.S. 102
3.17 U.S. Market for Musculoskeletal Products 105
3.18 U.S. Orthopedic Reconstruction Market 106
3.19 U.S. Back Pain Market 108
3.20 U.S. Market for Orthopedic Biomaterials 109
3.21 Landscape for Spinal Products in the U.S. 110
3.21.1 Reimbursement for Spinal Procedures 114
3.21.2 Causes of Spinal Cord Injuries in the U.S. 116
3.21.3 Most Common Spine Ailments in the U.S. 117
3.21.4 Disc Displacements 117
3.21.4.1 Degenerative Disc Disease 118
3.21.4.2 Vertebral Dislocation 118
3.21.4.3 Spondylosis 118
3.21.4.4 Growing Spinal Revenue 118
3.21.4.5 High Growth Rate by Large Companies 118
3.21.4.6 Medicare's Spine Surgery Burdens in the U.S. 119
3.21.4.7 Common Indications for Spine Surgery in the U.S. 119
3.21.4.8 Average Reimbursement by Indication 120
3.21.4.9 Medical Reimbursement and Treatment Alternatives 120
3.21.4.10 Comorbidities in Lumbar Fusion: Medicare vs. Private Pay 121
3.21.4.11 Providers and Reimbursement for Lumbar Spine Fusion in the U.S 122
3.21.4.12 Artificial Disc, Facet and Nucleus Replacement and Dynamic
Stabilization 123
3.21.5 U.S. Spine Market 126
3.22 Total Knee Arthroplasty in the U.S. 127
3.23 U.S. Market for Endoscopic Surgery Products 129
3.24 Market for Bone Graft Substitutes in the U.S. 130
3.25 U.S. Orthopedic Biomaterials Market 130
3.26 U.S. Market for Orthopedic Soft Tissue and Sports Medicine 131
3.27 Orthopedic Surgeons in the U.S. 132
3.28 Orthopedic Brace and Support Market in the U.S. 132
3.29 Orthopedics in Europe 133
3.30 Orthopedic Device Market in China 134
3.30.1 Growth Drivers 134
3.30.2 Chinese Orthopedics Market Size and Growth 135
3.30.3 Major Orthopedic Device Players in China 136
4. Company Profiles 138
4.1 aap Implantate AG 138
4.1.1 aap's Bone Replacement Products 138
4.1.1.1 PerOssal 138
4.1.1.2 Ostim 138
4.1.1.3 Cerabone 139
4.1.2 Soft Tissue Regeneration 139
4.1.2.1 AdconGel 139
4.1.2.2 Jason 139
4.1.2.3 Hynoval 139
4.1.3 aap's Cementing Techniques 140
4.1.3.1 Easymix 140
4.1.3.2 MicroAire Hi Speed Pulse Lavage System 140
4.1.4 aap's Trauma Products 140
4.1.4.1 Angle-Stable Plates 140
4.1.4.2 Proximal Humerus Plate 140
4.1.4.3 Angle Stable Distal Radial Plate 141
4.1.4.4 Trauma Shoulder System 141
4.2 AlloSource 141
4.2.1 AlloSource's Selected Osteobiologics 141
4.2.1.1 AlloFuse DBM Putty 142
4.2.1.2 AlloSource's Spinal Grafts 142
4.2.1.3 Sports Medicine Grafts 142
4.3 Alphatec Spine 142
4.3.1 The Alphatec Solution 143
4.3.2 Alphatec's Business Performance 144
4.4 Amedica/U.S. Spine 144
4.4.1 Amedica/U.S. Spine's Products 145
4.4.1.1 Valeo C-Cervical Spacer 145
4.4.1.2 Valeo TL-Lumbar Spacer 145
4.4.1.3 Valeo PL-Lumbar Spacer 145
4.4.1.4 Valeo OL-Lumbar Spacer 146
4.4.1.5 Valeo AL-Lumbar Spacer 146
4.4.1.6 Valeo CP-Cervical Plate System 146
4.4.1.7 Valeo Concise-Anterior Cervical Plate System 146
4.4.1.8 Valeo PS-Pedicle Screw System 147
4.4.1.9 Valeo BP-Synthetic Bone Putty 147
4.5 Anika Therapeutics, Inc. 147
4.5.1 Anika's Products 148
4.5.1.1 Orthovisc 148
4.5.1.2 Monovisc 148
4.5.1.3 Orthovisc mini 148
4.6 ApaTech 148
4.6.1 Actifuse ABX 148
4.7 Arteriocyte Medical Systems, Inc. 148
4.7.1 Arteriocyte's Role in Orthopedic Regenerative Medicine 149
4.8 Artimplant 149
4.8.1 Artimplant's Product Portfolio and Market 149
4.8.1.1 Resurfacing: Restoring the Joint Surface 149
4.8.1.2 Reinforcement of Tissue 149
4.8.1.3 Replenishment: Augmentation of Tissue Volume 150
4.9 ArthoCare Corporation 150
4.9.1 ArthoCare's Arthroscopic Business Segment 150
4.9.2 ArthoCare's Spine Business Segment 151
4.9.3 ArthoCare's Spine Products 151
4.9.3.1 SpineWand Product Line 151
4.9.3.2 Parallax Product Line 151
4.10 Ascension Orthopedics, Inc. 151
4.10.1 Selected Products from Ascension 152
4.10.1.1 PyroCarbon MCP 152
4.10.1.2 PyroCarbon PIP 152
4.10.1.3 Silicone PIP 152
4.10.1.4 NuGrip CMC Implant 152
4.10.1.5 Ascension Movement Hemi Great Toe System 153
4.11 Aesculap 153
4.11.1 Selected Products from Aesculap/B. Braun 153
4.11.1.1 Bicontact Universal Hip System 153
4.11.1.2 Metha Short Hip Stem 153
4.11.1.3 Excia Hip Stem 154
4.11.1.4 Prevision Modular Hip Revision Stem 154
4.11.1.5 Plasmacup SC Acetabular Cup 154
4.11.1.6 MIOS Minimally-Invasive Orthopedic Solutions 154
4.11.1.7 e.motion Total Knee System 155
4.11.1.8 Columbus Total Knee System 155
4.11.1.9 EnduRo Rotating Hinge Knee System 155
4.11.1.10 Univation Unicondylar Knee System 156
4.11.1.11 Search Evolution Total Knee System 156
4.11.1.12 MIOS Minimally-Invasive Orthopedic Solutions 156
4.12 AxioMed Spine Corporation 156
4.12.1 Freedom Lumbar Disc 157
4.13 Biocomposites Ltd. 157
4.14 Bacterin International, Inc. 158
4.15 BioMimetic Therapeutics, Inc. 158
4.15.1 BioMimetic's Product Candidates 158
4.16 BioSurface Engineering Technologies, Inc. 160
4.16.1 Amplex 160
4.17 Bone Biologics, Inc. 160
4.17.1 UCB-1 160
4.17.2 UCS-1 160
4.18 BoneSupport AB 160
4.19 Biomet, Inc. 161
4.19.1 Biomet's Products 161
4.19.2 Reconstructive Products 162
4.19.2.1 Knee Systems 162
4.19.2.2 Hip Systems 162
4.19.3 Extremity Systems 162
4.19.4 Dental Reconstructive Devices 163
4.19.5 Spinal Products 163
4.19.5.1 Spine Fusion Stimulation Systems 163
4.19.5.2 Spinal Fixation Systems 163
4.19.6 Bone Substitute and Allograft Materials 164
4.20 Bone Solutions, Inc. 164
4.20.1 OsteoCrete Bone Void Filler 164
4.21 Ceramisys Ltd. 165
4.21.1 ReproBone 165
4.22 Cerapedics, Inc. 165
4.23 Collagen Matrix, Inc. 165
4.23.1 OssiMend Bone Graft Matrix 165
4.23.2 OssiMend Block Bone Graft Matrix 166
4.23.3 OssiMend Putty Bone Graft Matrix 166
4.23.4 DuraMatrix-Onlay Collagen Dura Substitute Membrane 166
4.23.5 DuraMatrix Collagen Dura Substitute Membrane 166
4.23.6 TenoMend Collagen Tendon Wrap 167
4.23.7 OssiGuide Cancellous Granules 167
4.23.8 OssiPatch Collagen Bone Healing Protective Sheet 167
4.23.9 SynOss Synthetic Mineral 167
4.24 Conmed Linvatec Corporation 168
4.24.1 Conmed's Arthroscopy Products 168
4.24.2 Conmed's Powered Surgical Instruments 169
4.24.3 Conmed's Electrosurgery Products 170
4.24.4 Conmed's Patient Care Products 171
4.24.5 Conmed's Endosurgery Products 171
4.24.6 Conmed's Endoscopy Products 172
4.24.7 Conmed's Business Performance 173
4.25 Core Essence Orthopaedics, Inc. 173
4.25.1 TAC-tite 173
4.25.2 reVERTO Shape Memory Staple System 174
4.25.3 SEG-WAY Endoscopic Guide System 174
4.25.4 reNOVO Suture Anchor System 174
4.25.5 PONTiS Endotendonous Repair System 174
4.26 Corin Group PLC 175
4.27 DePuy Spine, Inc. 175
4.27.1 DePuy Spine's Biologic Solutions 176
4.27.1.1 Symphony Platelet Concentrate System 176
4.27.1.2 Conduit TCP Granules 176
4.27.1.3 Healos Bone Graft Replacement 176
4.27.1.4 Healos Fx Injectable Bone Graft Replacement 177
4.27.1.5 Overview of Other Products from DePuy Spine, Inc. 177
4.28 DeRoyal, Inc. 179
4.28.1 DeRoyal's Orthopedic Product Portfolio 180
4.28.1.1 Cervical Collars and Traction 180
4.28.1.2 Clavicle Straps 180
4.28.1.3 Shoulder Immobilizers 180
4.28.1.4 Arm Slings and Elevators 181
4.28.1.5 Elbow Supports and Sleeves 181
4.28.1.6 Wrist and Thumb Splints 181
4.28.1.7 Aluminum Splints 181
4.28.1.8 Abdominal Binders and Rib Belts 182
4.28.1.9 Knee Immobilizers 182
4.28.1.10 Bucks Traction 182
4.28.1.11 Post-Op Shoes 182
4.29 DJO Finance, LLC (DJOFL) 183
4.29.1 DJOFL's Operating Segments 183
4.29.2 DJOFL's Products 183
4.29.3 DJOFL's Business Performance 185
4.30 Etex Corporation 185
4.31 Exactech, Inc. 185
4.31.1 Exatech's Products 186
4.31.1.1 Knee Implants 186
4.31.1.2 Hip Implants 186
4.31.1.3 Biologics and Spine 187
4.31.1.4 Extremities 187
4.31.1.5 Other Products 187
4.31.2 Exactech's Business Performance 188
4.32 Facet Solutions, Inc. 188
4.32.1 Acadia Facet Replacement System 188
4.33 Gentis, Inc. 188
4.33.1 Gentis' Technology 189
4.34 Genzyme Corporation 189
4.34.1 Genzyme's Biosurgery Unit Performance 189
4.35 Geron Corporation 190
4.36 Globus Medical, Inc. 190
4.37 GMReis 193
4.38 Graftys SA 194
4.39 Inion Oy 195
4.40 Integra LifeSciences Holdings Corporation 195
4.40.1 Integra's Orthopedic Products 196
4.40.1.1 Nerve and Tendons 196
4.40.1.2 Bone and Joint Fixation Devices and Instruments 196
4.40.1.3 Bone Graft Substitutes for Extremity Reconstruction 196
4.40.1.4 Spinal Fusion Devices 197
4.40.1.5 Supplemental Fixation Systems 197
4.40.1.6 Interbody/Vertebral Body Replacements 197
4.40.1.7 OrthoBiologics 197
4.40.1.8 Minimally-Invasive Solutions 198
4.40.2 Integra's Business Performance 198
4.41 Interventional Spine, Inc. 199
4.42 ISTO Technologies, Inc. 199
4.42.1 InQu 199
4.42.2 NuQu 199
4.42.3 DeNovo ET 199
4.43 K2M, Inc. 200
4.44 Kasios 201
4.45 Kensey Nash Corporation 201
4.46 Kyphon, Inc. 202
4.47 Lanx, Inc. 203
4.48 LDR Holding Corporation 203
4.48.1 ROI 203
4.48.2 ROI-T 204
4.48.3 SpineTune TL 204
4.48.4 EasySpine 204
4.48.5 ROI-A 205
4.48.6 ROI-C 205
4.49 LifeSpine, Inc. 205
4.50 Medartis 206
4.51 Medtronic, Inc. 208
4.51.1 Medtronic's Spinal Implant Products 209
4.52 Mekanika, Inc. 210
4.53 Mesoblast 210
4.53.1 Mesoblast's MPC Technology 210
4.53.2 Mesoblast's Cartilage Regeneration Technology 210
4.53.3 Mesoblast's Technology for Disc Regrowth 211
4.54 MiMedx Group, Inc. 211
4.54.1 HydroFix 211
4.54.2 CollaFix 211
4.55 Nanotherapeutics, Inc. 211
4.55.1 Origen DBM 211
4.55.2 NanoFUSE 212
4.56 NovaBone Products, LLC 212
4.56.1 NovaBone's Products 212
4.56.1.1 NovaBone 212
4.56.1.2 NovaBone Putty 212
4.56.1.3 NovaBone Particulate 213
4.56.1.4 NovaBone Morsels 213
4.56.1.5 NovaBone Dental Putty 213
4.56.1.6 PerioGlas 213
4.57 NuVasive, Inc. 213
4.57.1 NuVasive's Recent Product Introductions 213
4.57.2 NuVasive Solutions 214
4.57.2.1 Maximum Access Surgery (MAS) 214
4.57.2.2 MAS-NeuroVision 214
4.57.2.3 MAS-MaXcess 214
4.57.2.4 MAS-Specialized Implants 214
4.57.2.5 MAS-Biologics 214
4.57.3 NuVasive's Business Performance 215
4.58 Olympus Terumo Biomaterials Corporation 215
4.59 Orteq Sports Medicine 216
4.59.1 Actifit 216
4.60 Orthofix International, NV 216
4.60.1 Orthofix's Business Segments and Market Sectors 216
4.60.2 Orthofix's Products 217
4.61 Orthomimetics Ltd. 219
4.61.1 Chondriomimetic 219
4.62 OrthoScan, Inc. 219
4.62.1 OrthoScan FD 220
4.62.2 OrthoScan UC 220
4.63 Orthovita, Inc. 220
4.63.1 Orthovita's Patents and Proprietary Intellectual Property 220
4.63.2 Orthovita's Business Performance 221
4.64 ossur hf 222
4.64.1 Bracing and Supports 222
4.64.2 Prosthetics 222
4.64.3 Compression Therapy 222
4.64.4 Ossur's Business Performance in 2009 222
4.65 Osteotech, Inc. 223
4.65.1 Osteotech's Products 223
4.65.2 Osteotech's Business Segments 224
4.66 Pioneer Surgical Orthobiologics, Inc. 224
4.67 ProChon Biotech Ltd. 225
4.67.1 BioCart 226
4.68 Ranier Technology 226
4.68.1 Cadisc-L 226
4.68.2 Cadisc-C 226
4.69 ReGen Biologics, Inc. 226
4.69.1 Menaflex 227
4.70 RTI Biologics, Inc. 227
4.70.1 RTI's Products and Distributors 228
4.71 Small Bone Innovations, Inc. 229
4.72 Smith and Nephew 231
4.73 SpinalKinetics 231
4.73.1 M6 Artificial Disc 232
4.74 Spinal Restorations, Inc. 232
4.74.1 Biostat System 232
4.75 Spine Smith, LP 232
4.76 Soft Tissue Regeneration, Inc. 233
4.76.1 STR's Technology 233
4.77 Stryker Corporation 233
4.77.1 Stryker's Product Sales 233
4.77.2 Stryker's Orthopedic Implants 233
4.77.2.1 Stryker's Hip Implant Systems 234
4.77.2.2 Stryker's Primary Femoral Hip Systems 234
4.77.2.3 Stryker's Primary Acetabular Systems 234
4.77.2.4 Stryker's Revision Hip Systems 234
4.77.2.5 Stryker's Resurfacing Hip Systems 234
4.77.2.6 Stryker's Knee Implant Systems 235
4.77.2.7 Stryker's Other Joint Replacement Products 235
4.77.2.8 Stryker's Bone Cement 235
4.77.2.9 Stryker's Trauma Implant Systems 235
4.77.2.10 Stryker's Spinal Implant Systems 236
4.77.2.11 Craniomaxillofacial (CMF) Implant Systems 236
4.77.2.12 OP-1/BMP-7 236
4.77.3 Stryker's MedSurge Equipments 237
4.77.4 Stryker's Business Performance 238
4.78 Symmetry Medical, Inc. 238
4.78.1 Symmetry's Products 239
4.78.1.1 Symmetry's Implants 239
4.78.2 Symmetry's Instruments 239
4.78.3 Symmetry's Cases 239
4.78.4 Symmetry's Customers 239
4.78.5 Symmetry's Business Performance 240
4.79 Synovis Life Technologies, Inc. 240
4.79.1 Synovis' Biomaterial Products 240
4.79.2 Synovis' Microsurgery Products 241
4.80 Synthes, Inc. 241
4.80.1 Synthes' Business Performance by Geography 241
4.80.2 Trauma Products from Synthes 242
4.81 ThermoGenesis Corporation 242
4.81.1 AutoXpress Platform 243
4.81.2 MarrowXpress 243
4.81.3 BioArchive System 243
4.81.4 Res-Q 60 BMC 243
4.81.5 Thermoline 243
4.81.6 CryoSeal Fibrin Sealant (CryoSeal) System 243
4.82 TiGenix NV 243
4.82.1 ChondroCelect 244
4.82.2 Chondromimetic 244
4.82.3 TGX003 244
4.82.4 Stem Cells 244
4.83 TissueGene, Inc. 244
4.83.1 TissueGene's Technology 244
4.84 Tissue Genesis, Inc. 245
4.84.1 Cell Isolation System 245
4.85 Tornier, Inc. 245
4.86 TranS1 247
4.86.1 TranS1's Solution 247
4.86.2 The Impressive Performance of TranS1's Business 247
4.87 Velcura Therapeutics, Inc. 248
4.88 Vertebron 248
4.88.1 Vertebron PSS-Pedicle Screw System 248
4.88.2 Vertebron SSP Semi-Constrained Cervical Plate 249
4.88.3 ACIF-Anterior Cervical and PLIF-Posterior Lumbar (Allografts) 249
4.88.4 PEEK Vertical Body Replacements Devices 249
4.88.5 Cervical Motion Preservation (CMP) 249
4.89 Wright Medical Group, Inc. 250
4.89.1 Wright's Products 250
4.89.2 Wright's Business Performance 251
4.90 X-Spine Systems, Inc. 252
4.91 Xylos Corporation 253
4.91.1 Xylos' Technology Applications in Musculoskeletal Disorders 253
4.92 Zimmer Holdings, Inc. 254
4.92.1 Zimmer's Customers 254
4.92.2 Zimmer's Products 255
4.92.2.1 NexGen Complete Knee Solution 255
4.92.2.2 Natural-Knee II System 255
4.92.2.3 Gender Solutions Natural-Knee Flex System 255
4.92.2.4 Innex Total Knee System 255
4.92.2.5 Zimmer Unicompartmental Knee Systems 255
4.92.2.6 Zimmer Patient-Specific Instruments 256
4.92.2.7 Zimmer Segmental System 256
4.92.2.8 Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology 256
4.92.2.9 Alloclassic (Zweymuller) Hip System 256
4.92.2.10 CLS Spotorno Hip System 256
4.92.2.11 Fitmore Hip Stem 256
4.92.2.12 VerSys Hip System 256
4.92.2.13 Continuum Acetabular System, Trilogy IT Acetabular System and
Allofit IT Alloclassic Acetabular System 257
4.92.2.14 Zimmer MMC Cup 257
4.92.2.15 Trilogy Acetabular System 257
4.92.2.16 Bigliani/Flatow Complete Shoulder Solution Family 257
4.92.2.17 Trabecular Metal Glenoid 257
4.92.2.18 Trabecular Metal Reverse Shoulder System 257
4.92.2.19 Anatomical Shoulder System 257
4.92.2.20 Coonrad/Morrey Total Elbow 257
4.92.2.21 Tapered Screw-Vent Implant System 258
4.92.2.22 AdVent Implant System 258
4.92.2.23 Tapered SwissPlus Implant System 258
4.92.2.24 Zimmer Hex-Lock Contour Abutment and Restorative Products 258
4.92.2.25 Puros Allograft Products 258
4.92.2.26 Dynesys Dynamic Stabilization System 258
4.92.2.27 PathFinder Minimally-Invasive Pedicle Screw System 259
4.92.2.28 Sequoia Pedicle Screw System 259
4.92.2.29 Ardis Interbody System 259
4.92.2.30 Trinica Select Anterior Cervical Plating System 259
4.92.2.31 Biological Products 259
4.92.2.32 Wallis Posterior Dynamic Stabilization System 259
4.92.2.33 Zimmer Natural Nail System 259
4.92.2.34 NCB Polyaxial Locking Plate System 259
4.92.2.35 Zimmer Periarticular Locking Plate System 259
4.92.2.36 Zimmer Universal Locking System 260
4.92.2.37 Zimmer Cable-Ready System 260
4.92.2.38 Palacos Bone Cement 260
4.92.2.39 Hi-Fatigue Bone Cement 260
4.92.2.40 Automatic Tourniquet Systems (A.T.S.) 260
4.92.2.41 Pulsavac Plus, Pulsavac Plus AC and Pulsavac Plus LP Wound
Debridement System 260
4.92.2.42 Zimmer Blood Reinfusion System (ZBRS) and Hemovac Blood Management
Systems 260
4.92.3 Zimmer's Research and Development 261
Appendix 1: Osteoporosis 263
Appendix 1.1: Osteoporosis-General 263
Appendix 1.2: Osteoporosis in Men 263
Appendix 1.3: Hip Fracture 263
Appendix 1.4: Vertebral Fracture 264
Appendix 1.5: Key Statistics for Europe 264
Appendix 1.6: Key Statistics for North America 264
Appendix 1.7: Key Statistics for Latin America 265
Appendix 1.8: Key Statistics for Middle East/North Africa 265
Appendix 1.9: Key Statistics for Asia 266
Appendix 1.10: Key Statistics for Oceania 266
Appendix 2: Statistics and Facts about Orthopedics and Orthopedic Practices in
the U.S. 267
Appendix 3: Advances in Internal Bone Fixation 267
Appendix 3.1: Wires and Cables in Revision Surgery 268
Appendix 3.2: Problems from Broken Metal Cerclage Wires to Patients 268
Appendix 3.3: New Product Replacing Cerclage Cables 268
Appendix 4: Spinal Cord Injury Facts and Statistics 270
Appendix 5: Facts on Orthopedics, Clinical Trials, and Regulatory and
Reimbursement Issues 272
Appendix 5.1: Clinical Trial Facts 272
Appendix 5.2: Clinical Trial Enrollment 273
Appendix 5.3: Clinical Trial Participants 274
Appendix 5.4: Clinical Trial Spending and Other Facts 274
Appendix 5.5: Musculoskeletal Pharma/Biologic Facts 275
Appendix 5.6: Regulatory Facts 275
Appendix 5.7: 510(k) Applications 275
Appendix 5.8: Investigational Device Exemption and Premarket Approval
Application (PMA) 276
Appendix 5.9: Reimbursement Facts 277
Appendix 5.9.1: National Healthcare Spending in the U.S. 277
Appendix 5.9.2: Reimbursement 277
Appendix 5.9.3: Medicare/Medicaid 278
Appendix 5.9.4: Insurance 278
Appendix 6: Medicare Rule and its Impact on Orthopedic Technology Firms 279
Appendix 6.1: Ills of the U.S. Orthopedics Market 280
Appendix 6.2: Current Orthopedics Business Environment 280


INDEX OF FIGURES

Figure 2.1: Trends in Implant Price, Physician and Hospital Medicare Payment,
1991 and 2010 31
Figure 2.2: Trend in Total and Femoral Resurfacing Hip Procedures, 2005-2009 35
Figure 2.3: Percent Market Share of Coated Hip Stems by Company, 2009 37
Figure 2.4: Percent Market Share of Uncoated Femur/Poly Liner Constructs by
Company, 2009 37
Figure 2.5: Percent of Cases by Construct Type, 2008 38
Figure 2.6: Percent of Cases by Knee Implant Construct Type, 2008 40
Figure 2.7: Lumbar TDR Revenue, 2007-2015 53
Figure 2.8: Cervical TDR Revenue, 2007-2015 54
Figure 2.9: Common Primary Diagnoses Associated with Inpatient Decompression
Procedures 55
Figure 2.10: Percutaneous Discectomy Procedures by Site of Care 55
Figure 2.11: Percent Distribution of Spinal Deformity Diagnoses 56
Figure 2.12: Usage of Instrumentation in Lumbar Fusion 57
Figure 2.13: Most Common Complications from Posterior Lumbar Fusion in Males 58
Figure 2.14: Leading Companies in Foot and Ankle Surgical Products 59
Figure 2.15: Percent Ankle Fusion and Ankle Replacement Procedures in the U.S.
60
Figure 2.16: Progression of Bunion Disorder in Males and Females, 2004-2010 63
Figure 2.17: Carpal Tunnel Syndrome Occurrences by Gender 65
Figure 2.18: Common Associated Diagnoses Treated by ESWT Procedure 67
Figure 3.1: Growth of North American Population Aged 65 and Over, 2010-2020 75
Figure 3.2: Growth of Western European Population Aged 65 and Over, 2010-2020 76
Figure 3.3: Life Expectancy in North America, 2010-2020 76
Figure 3.4: Top Seven Medical Device Segments in the U.S., 2009 78
Figure 3.5: Percent Market Share of the Sub-Sectors of Orthopedics, 2009 79
Figure 3.6: Percent Global Market for Orthopedics by Product Segment, 2009 84
Figure 3.7: Global Orthopedics Market by Company, 2009 85
Figure 3.8: Percent Global Orthopedics Market by Geography, 2009 86
Figure 3.9: Global Market for Orthopedics, 2009-2016 86
Figure 3.10: Global Spinal Market Share by Company, 2009 87
Figure 3.11: Global Market for Spinal Implants, 2009-2016 88
Figure 3.12: Global Orthopedics Reconstructive Market Share by Company, 2009 88
Figure 3.13: Market for Orthopedic Reconstruction Devices, 2009-2016 90
Figure 3.14: Global Trauma and Craniomaxillofacial Market Share by Company, 2009
91
Figure 3.15: Global Market for Trauma and Craniomaxillofacial Products,
2009-2016 91
Figure 3.16: Market Share in Global Joint Replacement by Company, 2009 92
Figure 3.17: Percent Global Fracture Repair Market by Segment, 2009 93
Figure 3.18: Global Fracture Repair Market Share by Company, 2009 93
Figure 3.19: Fractures by Patient's Age 94
Figure 3.20: Global Market Share of Craniomaxillofacial Products by Market
Leaders, 2009 95
Figure 3.21: Growth of Global Surgical Instruments Market, 2009-2015 95
Figure 3.22: Global Orthobiologics Market Share by Company, 2009 97
Figure 3.23: Global Market for Orthobiologic Products, 2009-2016 98
Figure 3.24: Global Orthopedic Operating Room Equipment Market Share by Company,
2009 98
Figure 3.25: Global Endoscopy Market by Company, 2009 99
Figure 3.26: Global Market for Non-Invasive Orthopedics, 2009-2016 100
Figure 3.27: Percent Breakdown of Costs for Hip/Knee Replacement Surgeries in
the U.S., 2009 103
Figure 3.28: Percent U.S. Market for Musculoskeletal Products, 2009 105
Figure 3.29: Percent U.S. Orthopedic Reconstructive Products Market, 2009 106
Figure 3.30: Percent U.S. Fixation Market, 2009 107
Figure 3.31: U.S. Spinal Products Market, 2009 107
Figure 3.32: U.S. Spinal Products Market, 2009-2016 108
Figure 3.33: U.S. Market for Back Pain Drugs, 2008-2018 109
Figure 3.34: U.S. Market for Biomaterials in Orthopedics, 2009-2016 110
Figure 3.35: Spine Company Market Share Summary, 2010 112
Figure 3.36: Spine Diagnoses in People Younger Than 65 Years of Age in the U.S.
115
Figure 3.37: Causes of Spinal Cord Injuries 116
Figure 3.38: Lumbar Fusion by Approach 117
Figure 3.39: Primary Inpatient Procedures in Treating Lumbar Spinal Stenosis 121
Figure 3.40: Incidence of Diabetes: Medicare Population and Private Pay
Population 122
Figure 3.41: Average Charges per Region 128
Figure 3.42: Payment Distribution in Total Knee Replacement 129
Figure 3.43: Growth of Endoscopic Surgery Products in the U.S., 2009-2014 130
Figure 3.44: U.S. Market for Orthopedic Biomaterials, 2009-2016 131
Figure 3.45: U.S. Market for Soft Tissue and Sports Medicine, 2009-2016 131
Figure 3.46: Percent of Orthopedic Surgeons by Sub-Specialties, 2009 132
Figure 3.47: U.S. Market for Orthopedic Braces and Supports, 2005 and 2009 132
Figure 3.48: Orthopedics Reconstructive Market Leaders in Europe, 2008 133
Figure 3.49: European Trauma Market Share by Company, 2008 134
Figure 3.50: Size of Aging Population (65+) in Selected Countries, 2008 135
Figure 3.51: Prevalence of Arthritis in Selected Countries, 2008 135
Figure 3.52: Growth of Chinese Orthopedics Market, 2006-2009 136
Figure 4.1: Alphatec's Business Performance, 2005-2009 144
Figure 4.2: Biomet's Percent Business Performance by Product Category, 2009 161
Figure 4.3: Conmed's Business Performance, 2005-2009 173
Figure 4.4: Exactech's Overall Business Performance, 2005-2009 188
Figure 4.5: Integra's Overall Business Performance, 2005-2009 198
Figure 4.6: Medtronic's Percent Revenue by Operating Segments, 2010 209
Figure 4.7: NuVasive's Business Growth, 2005-2009 215
Figure 4.8: Orthofix's Overall Business Performance, 2005-2009 219
Figure 4.9: Orthovita's Business Performance, 2005-2009 222
Figure 4.10: Stryker's Overall Business Performance, 2005-2009 238
Figure 4.11: Synthes' Percent Market Share by Geography, 2009 242
Figure 4.12: TranS1's Impressive Growth in Business, 2005-2009 247
Figure 4.13: Wright's Overall Business Performance, 2005-2009 252
Figure 4.14: Zimmer's Percent Business Performance by Geography, 2009 255
Figure A5.1: Share of Clinical Trial Funding by Source, 2009 272
Figure A5.2: Clinical Study Participants' Primary Concerns 273
Figure A5.3: Factors Impacting Clinical Study Participation 274
Figure A5.4: Capital Raised by Device Companies for PMA and 510k Approvals,
2005-2009 276
Figure A5.5: Total FDA PMA Submissions and Approvals, 2004-2009 276
Figure A6.1: Percent Change in Medicare Payment According to 2010 IPPS Rule 279
Figure A6.2: Economic Inequality Between Orthopedic Surgeon and Sales
Representative, 2009 281
Figure A6.3: Percent Generic and Brand Name Prescriptions, 1984 and 2009 281


INDEX OF TABLES

Table 2.1: Selected Hip Products from the Top Two Market Leaders 23
Table 2.2: Most Common Large Joint Disorders: Disorders of the Hip 25
Table 2.3: Available Viscosupplements in the Market 28
Table 2.4: Injections and Following Procedures, 2004 and 2005 29
Table 2.5: Cost of Synovial Injections 29
Table 2.6: Knee Products from the Zimmer 30
Table 2.7: Change in Hip and Knee Implant List Prices, 2009 and 2010 32
Table 2.8: Total Hips/Resurfacing Prices by Manufacturer and Implant Type, 2009
32
Table 2.9: Partial Hips Prices by Manufacturer and Implant Type, 2009 33
Table 2.10: Knee Prices by Manufacturer and Implant Type, 2009 33
Table 2.11: Case Share of Total Hip Implant Assemblies, 2009 34
Table 2.12: Change in Femoral Resurfacing List Prices, 2009 and 2010 34
Table 2.13: Change in Metal-on-Metal Hip Implant List Prices, 2009 and 2010 35
Table 2.14: Change in Ceramic-on-Ceramic List Prices, 2009 and 2010 36
Table 2.15: Change in Coated Stem Poly Liner Hip Implant List Price, 2009 and
2010 36
Table 2.16: Case Shares of Partial Hip Implant Assemblies, 2009 38
Table 2.17: Change in Bipolar Hip Implant List Prices, 2009 and 2010 39
Table 2.18: Change in Modular Endoprostheses List Prices, 2009 and 2010 39
Table 2.19: Change in Coated Knee Implant List Prices, 2009 and 2010 40
Table 2.20: Change in Uncoated Knee Implant List Prices, 2009 and 2010 41
Table 2.21: Change in Hybrid Knee Implant List Prices, 2009 and 2010 41
Table 2.22: Change in Knee with All Poly Tibia List Prices, 2009 and 2010 42
Table 2.23: Change in Unicondylar Knee Implant List Prices, 2009 and 2010 42
Table 2.24: Top Five Shoulder-Related Diagnoses and the Baby Boomer Population
45
Table 2.25: Pedicle-Based Motion Preservation Devices and Their Indications 48
Table 2.26: Primary Inpatient Diagnoses of Spinal Disorders 49
Table 2.27: Average Reimbursement for Spine Indications 49
Table 2.28: Spinal Procedure Reimbursements 50
Table 2.29: Common Providers of Posterior Lumbar Fusion in Elderly Patients 50
Table 2.30: VCF Treatment by Site of Care and Levels Treated 51
Table 2.31: Age Ranges of the Most Common Spine Diagnoses 51
Table 2.32: Procedure Volumes for Patients More Than 64 Years of Age, 2007 and
2009 52
Table 2.33: TDR and Spine Fusion Primary Diagnoses 53
Table 2.34: Deformities of Toes Diagnoses, 2004-2007 61
Table 2.35: Average Charges for Toe Deformities 61
Table 2.36: Procedures for Treating Plantar Fascial Fibromatosis 62
Table 2.37: Pe

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