Orthopedics Markets

1. Overview 16
1.1 Statement of Report 16
1.2 Scope of the Report 18
1.3 Methodology 18
1.4 Executive Summary 20
2. An Overview of Selected Orthopedic Surgical Procedures and Products 22
2.1 Scope of this Chapter 22
2.2 Surgery for Hip Implants 22
2.2.1 Cemented Hip Implants 22
2.2.2 Porous Hip Implants 22
2.2.3 Preparing for Hip Implant Surgery 22
2.2.4 Hip Surgery 23
2.2.5 Market Leaders in Hip and Knee Implants 24
2.2.6 Benefits of Hip and Knee Replacement 25
2.2.7 Most Common Hip Disorders 25
2.2.8 Total Hip Arthroplasty at the Global Level 26
2.3 Surgery for Knee Implants 27
2.3.1 Gender-Specific Knee 28
2.3.2 Viscosupplementation for the Osteoarthritis of the Knee 29
2.3.3 Synovial Injections and Efficacy 29
2.3.4 Market Leader’s in Knee Products 30
2.3.5 Pricing Trends in Hip and Knee Implants 32
2.3.5.1 Total Hips 35
2.3.5.2 Partial Hips 38
2.3.6 Knee Implants 40
2.4 Shoulder Implants 43
2.4.1 Reverse Shoulder Replacement 45
2.4.2 Total Shoulder Replacement 45
2.4.3 Rotator Cuff Repair 46
2.5 Spine Anatomy 47
2.5.1 Spine Disorders 47
2.5.2 Spinal Implants 48
2.5.3 Spinal Fusion Surgery 48
2.5.4 Spinal Stabilization 48
2.5.5 Common Indications for Spine Surgery in the Elderly 49
2.5.6 Average Reimbursement by Spinal Indication 50
2.5.7 Medicare Reimbursements and Treatment Alternatives 50
2.5.8 Lumbar Spine Fusion: Providers and Reimbursement in the U.S. 50
2.5.9 Balloon Kyphoplasty 51
2.5.10 Elderly Spine Patients 52
2.5.11 Lumbar and Cervical Total Disc Replacement 53
2.5.12 Indications for Total Disc Replacement (TDR) 53
2.5.13 Percutaneous Procedures 55
2.5.14 Niche Markets in Spine 56
2.5.15 Complication Rates in Posterior Lumbar Fusion 57
2.6 Foot and Ankle 59
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 65
2.8 Tennis Elbow 66
2.9 Trauma in Extremities 66
2.10 Arthroscopy 67
2.11 Extracorporeal Shock Wave 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 70
2.12.4 Ceramic-Based Bone Graft Substitutes 70
2.12.5 Polymer-Based Bone Graft Substitutes 70
2.13 Electrical Stimulation in Fracture Healing 71
2.14 Materials Used in Orthopedic Implants 71
2.14.1 Implant Fabrication Process 72
2.14.2 Post-Fabrication Coatings 72
2.14.3 Forces Shaping the Implant Market 73
2.14.3.1 A New Class of Materials 73
2.14.4 Future Trends in Orthopedics 74
3. Orthopedics Market Analysis 75
3.1 Scope of this Chapter 75
3.2 Orthopedics Industry 75
3.3 Market Drivers in Orthopedics 76
3.3.1 Changing Lifestyle 76
3.3.2 Aging Population 76
3.3.3 Technology Advancements 78
3.3.4 Implants as Effective Alternatives to Drug Therapy 78
3.4 The Changing Focus of Medical Device Companies 78
3.5 The Primacy of Orthopedic Device Segment 79
3.6 Global Orthopedics Market 80
3.6.1 Market Leaders in Orthopedic Implants 81
3.6.2 Orthopedics Market Segment Overview 83
3.6.3 Global Orthopedics Market Leaders 85
3.6.4 Global Orthopedics Market by Geography 85
3.6.5 Future of Global Orthopedics Market 86
3.6.6 Global Spine Market 87
3.6.6.1 Future Market for Spinal Implants 88
3.7 Global Orthopedics Reconstructive Market 88
3.7.1 Future of Orthopedic Reconstruction Market 90
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 96
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 The 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. 115
3.21.3 Most Common Spine Ailments in the U.S. 116
3.21.4 Disc Displacements 116
3.21.4.1 Degenerative Disc Disease 117
3.21.4.2 Vertebral Dislocation 117
3.21.4.3 Spondylosis 117
3.21.4.4 The 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 119
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 122
3.21.5 The U.S. Spine Market 125
3.22 Total Knee Arthroplasty in the U.S. 126
3.23 U.S. Market for Endoscopic Surgery Products 128
3.24 Market for Bone Graft Substitutes in the U.S. 129
3.25 U.S. Orthopedic Biomaterials Market 129
3.26 U.S. Market for Orthopedic Soft Tissue and Sports Medicine 130
3.27 Orthopedic Surgeons in the U.S. 130
3.28 Orthopedic Brace and Support Market in the U.S. 131
3.29 Orthopedics in Europe 131
3.30 Orthopedic Device Market in China 133
3.30.1 Growth Drivers 133
3.30.2 Chinese Orthopedics Market Size and Growth 134
3.30.3 Major Orthopedic Device Players in China 135
4. Company Profiles 136
4.1 aap Implantate AG 136
4.1.1 aap’s Bone Replacement Products 136
4.1.1.1 PerOssal 136
4.1.1.2 Ostim 136
4.1.1.3 Cerabone 136
4.1.2 Soft Tissue Regeneration 137
4.1.2.1 AdconGel 137
4.1.2.2 Jason 137
4.1.2.3 Hynoval 137
4.1.3 aap’s Cementing Techniques 137
4.1.3.1 Easymix 137
4.1.3.2 MicroAire Hi Speed Pulse Lavage System 138
4.1.4 aap’s Trauma Products 138
4.1.4.1 Angle-Stable Plates 138
4.1.4.2 Proximal Humerus Plate 138
4.1.4.3 Angle Stable Distal Radial Plate 138
4.1.4.4 Trauma Shoulder System 139
4.2 AlloSource 139
4.2.1 AlloSource’s Selected Osteobiologics 139
4.2.1.1 AlloFuse DBM Putty 139
4.2.1.2 AlloSource’s Spinal Grafts 140
4.2.1.3 Sports Medicine Grafts 140
4.3 Alphatec Spine 140
4.3.1 The Alphatec Solution 140
4.3.2 Alphatec’s Business Performance 141
4.4 Amedica/U.S. Spine 142
4.4.1 Amedica/U.S. Spine’s Products 142
4.4.1.1 Valeo C—Cervical Spacer 142
4.4.1.2 Valeo TL—Lumbar Spacer 142
4.4.1.3 Valeo PL—Lumbar Spacer 143
4.4.1.4 Valeo OL—Lumbar Spacer 143
4.4.1.5 Valeo AL—Lumbar Spacer 143
4.4.1.6 Valeo CP—Cervical Plate System 143
4.4.1.7 Valeo Concise—Anterior Cervical Plate System 144
4.4.1.8 Valeo PS—Pedicle Screw System 144
4.4.1.9 Valeo BP—Synthetic Bone Putty 144
4.5 Anika Therapeutics, Inc. 145
4.5.1 Anika’s Products 145
4.5.1.1 Orthovisc 145
4.5.1.2 Monovisc™ 145
4.5.1.3 Orthovisc mini 145
4.6 ApaTech 146
4.6.1 Actifuse ABX 146
4.7 Arteriocyte Medical Systems, Inc. 146
4.7.1 Arteriocyte’s Role in Orthopedic Regenerative Medicine 146
4.8 Artimplant 146
4.8.1 Artimplant’s Product Portfolio and Market 147
4.8.1.1 Resurfacing: Restoring the Joint Surface 147
4.8.1.2 Reinforcement of Tissue 147
4.8.1.3 Replenishment: Augmentation of Tissue Volume 147
4.9 ArthoCare Corporation 148
4.9.1 ArthoCare’s Arthroscopic Business Segment 148
4.9.2 ArthoCare’s Spine Business Segment 148
4.9.3 ArthoCare’s Spine Products 149
4.9.3.1 SpineWand Product Line 149
4.9.3.2 The Parallax Product Line 149
4.10 Ascension Orthopedics, Inc. 149
4.10.1 Selected Products from Ascension 149
4.10.1.1 PyroCarbon MCP 149
4.10.1.2 PyroCarbon PIP 149
4.10.1.3 Silicone PIP 150
4.10.1.4 NuGrip CMC Implant 150
4.10.1.5 Ascension Movement Hemi Great Toe System 150
4.11 Aesculap 150
4.11.1 Selected Products from Aesculap/B. Braun 151
4.11.1.1 Bicontact Universal Hip System 151
4.11.1.2 Metha Short Hip Stem 151
4.11.1.3 Excia Hip Stem 151
4.11.1.4 Prevision Modular Hip Revision Stem 151
4.11.1.5 Plasmacup SC Acetabular Cup 152
4.11.1.6 MIOS Minimally-Invasive Orthopedic Solutions 152
4.11.1.7 e.motion Total Knee System 152
4.11.1.8 Columbus Total Knee System 153
4.11.1.9 EnduRo Rotating Hinge Knee System 153
4.11.1.10 Univation Unicondylar Knee System 153
4.11.1.11 Search Evolution Total Knee System 153
4.11.1.12 MIOS Minimally-Invasive Orthopedic Solutions 154
4.12 AxioMed Spine Corporation 154
4.12.1 Freedom Lumbar Disc 154
4.13 Biocomposites Ltd. 154
4.14 Bacterin International, Inc. 155
4.15 BioMimetic Therapeutics, Inc. 156
4.15.1 BioMimetic’s Product Candidates 156
4.16 BioSurface Engineering Technologies, Inc. 157
4.16.1 Amplex™ 157
4.17 Bone Biologics, Inc. 158
4.17.1 UCB-1™ 158
4.17.2 UCS-1™ 158
4.18 BoneSupport AB 158
4.19 Biomet, Inc. 158
4.19.1 Biomet’s Products 159
4.19.2 Reconstructive Products 159
4.19.2.1 Knee Systems 159
4.19.2.2 Hip Systems 160
4.19.3 Extremity Systems 160
4.19.4 Dental Reconstructive Devices 160
4.19.5 Spinal Products 161
4.19.5.1 Spine Fusion Stimulation Systems 161
4.19.5.2 Spinal Fixation Systems 161
4.19.6 Bone Substitute and Allograft Materials 161
4.20 Bone Solutions, Inc. 162
4.20.1 OsteoCrete Bone Void Filler 162
4.21 Ceramisys Ltd. 162
4.21.1 ReproBone™ 162
4.22 Cerapedics, Inc. 163
4.23 Collagen Matrix, Inc. 163
4.23.1 OssiMend Bone Graft Matrix 163
4.23.2 OssiMend Block Bone Graft Matrix 163
4.23.3 OssiMend Putty Bone Graft Matrix 163
4.23.4 DuraMatrix-Onlay Collagen Dura Substitute Membrane 164
4.23.5 DuraMatrix Collagen Dura Substitute Membrane 164
4.23.6 TenoMend Collagen Tendon Wrap 164
4.23.7 OssiGuide Cancellous Granules 164
4.23.8 OssiPatch Collagen Bone Healing Protective Sheet 165
4.23.9 SynOss Synthetic Mineral 165
4.24 Conmed Linvatec Corporation 165
4.24.1 Conmed’s Arthroscopy Products 166
4.24.2 Conmed’s Powered Surgical Instruments 167
4.24.3 Conmed’s Electrosurgery Products 167
4.24.4 Conmed’s Patient Care Products 168
4.24.5 Conmed’s Endosurgery Products 169
4.24.6 Conmed’s Endoscopy Products 169
4.24.7 Conmed’s Business Performance 170
4.25 Core Essence Orthopaedics, Inc. 171
4.25.1 TAC-tite™ 171
4.25.2 The reVERTO Shape Memory Staple System 171
4.25.3 SEG-WAY Endoscopic Guide System 171
4.25.4 The reNOVO Suture Anchor System 171
4.25.5 PONTiS Endotendonous Repair System 172
4.26 Corin Group PLC 172
4.27 DePuy Spine, Inc. 173
4.27.1 DePuy Spine’s Biologic Solutions 173
4.27.1.1 Symphony Platelet Concentrate System 173
4.27.1.2 Conduit TCP Granules 173
4.27.1.3 Healos Bone Graft Replacement 173
4.27.1.4 Healos Fx Injectable Bone Graft Replacement 174
4.27.1.5 Overview of Other Products from DePuy Spine, Inc. 174
4.28 DeRoyal, Inc. 176
4.28.1 DeRoyal’s Orthopedic Product Portfolio 177
4.28.1.1 Cervical Collars and Traction 177
4.28.1.2 Clavicle Straps 177
4.28.1.3 Shoulder Immobilizers 177
4.28.1.4 Arm Slings and Elevators 177
4.28.1.5 Elbow Supports and Sleeves 178
4.28.1.6 Wrist and Thumb Splints 178
4.28.1.7 Aluminum Splints 178
4.28.1.8 Abdominal Binders and Rib Belts 178
4.28.1.9 Knee Immobilizers 179
4.28.1.10 Bucks Traction 179
4.28.1.11 Post-Op Shoes 179
4.29 DJO Finance, LLC (DJOFL) 179
4.29.1 DJOFL’s Operating Segments 180
4.29.2 DJOFL’s Products 180
4.29.3 DJOFL’s Business Performance 182
4.30 Etex Corporation 182
4.31 Exactech, Inc. 182
4.31.1 Exatech’s Products 183
4.31.1.1 Knee Implants 183
4.31.1.2 Hip Implants 183
4.31.1.3 Biologics and Spine 184
4.31.1.4 Extremities 184
4.31.1.5 Other Products 184
4.31.2 Exactech’s Business Performance 185
4.32 Facet Solutions, Inc. 185
4.32.1 Acadia Facet Replacement System 185
4.33 Gentis, Inc. 185
4.33.1 Gentis’ Technology 186
4.34 Genzyme Corporation 186
4.34.1 Genzyme’s Biosurgery Unit Performance 186
4.35 Geron Corporation 187
4.36 Globus Medical, Inc. 187
4.37 GMReis 190
4.38 Graftys SA 191
4.39 Inion Oy 192
4.40 Integra LifeSciences Holdings Corporation 192
4.40.1 Integra’s Orthopedic Products 193
4.40.1.1 Nerve and Tendons 193
4.40.1.2 Bone and Joint Fixation Devices and Instruments 193
4.40.1.3 Bone Graft Substitutes for Extremity Reconstruction 193
4.40.1.4 Spinal Fusion Devices 194
4.40.1.5 Supplemental Fixation Systems 194
4.40.1.6 Interbody/Vertebral Body Replacements 194
4.40.1.7 OrthoBiologics 194
4.40.1.8 Minimally-Invasive Solutions 195
4.40.2 Integra’s Business Performance 195
4.41 Interventional Spine, Inc. 196
4.42 ISTO Technologies, Inc. 196
4.42.1 InQu 196
4.42.2 NuQu 196
4.42.3 DeNovo ET 196
4.43 K2M, Inc. 197
4.44 Kasios 198
4.45 Kensey Nash Corporation 198
4.46 Kyphon, Inc. 199
4.47 Lanx, Inc. 200
4.48 LDR Holding Corporation 200
4.48.1 ROI 200
4.48.2 ROI-T 201
4.48.3 SpineTune TL 201
4.48.4 EasySpine 201
4.48.5 ROI-A 202
4.48.6 ROI-C™ 202
4.49 LifeSpine, Inc. 202
4.50 Medartis 203
4.51 Medtronic, Inc. 205
4.51.1 Medtronic’s Spinal Implant Products 206
4.52 Mekanika, Inc. 207
4.53 Mesoblast 207
4.53.1 Mesoblast’s MPC Technology 207
4.53.2 Mesoblast’s Cartilage Regeneration Technology 207
4.53.3 Mesoblast’s Technology for Disc Regrowth 207
4.54 MiMedx Group, Inc. 208
4.54.1 HydroFix™ 208
4.54.2 CollaFix 208
4.55 Nanotherapeutics, Inc. 208
4.55.1 Origen DBM 208
4.55.2 NanoFUSE™ 208
4.56 NovaBone Products, LLC 209
4.56.1 NovaBone’s Products 209
4.56.1.1 NovaBone 209
4.56.1.2 NovaBone Putty 209
4.56.1.3 NovaBone Particulate 209
4.56.1.4 NovaBone Morsels 210
4.56.1.5 NovaBone Dental Putty 210
4.56.1.6 PerioGlas 210
4.57 NuVasive, Inc. 210
4.57.1 NuVasive’s Recent Product Introductions 210
4.57.2 The NuVasive Solutions 211
4.57.2.1 Maximum Access Surgery (MAS) 211
4.57.2.2 MAS—NeuroVision 211
4.57.2.3 MAS—MaXcess 211
4.57.2.4 MAS—Specialized Implants 211
4.57.2.5 MAS—Biologics 211
4.57.3 NuVasive’s Business Performance 211
4.58 Olympus Terumo Biomaterials Corporation 212
4.59 Orteq Sports Medicine 212
4.59.1 Actifit 213
4.60 Orthofix International, NV 213
4.60.1 Orthofix’s Business Segments and Market Sectors 213
4.60.2 Orthofix’s Products 214
4.61 Orthomimetics Ltd. 216
4.61.1 Chondriomimetic 216
4.62 OrthoScan, Inc. 216
4.62.1 OrthoScan FD 216
4.62.2 OrthoScan UC 216
4.63 Orthovita, Inc. 217
4.63.1 Orthovita’s Patents and Proprietary Intellectual Property 217
4.63.2 Orthovita’s Business Performance 218
4.64 Ossur hf 218
4.64.1 Bracing and Supports 218
4.64.2 Prosthetics 219
4.64.3 Compression Therapy 219
4.64.4 Ossur’s Business Performance in 2009 219
4.65 Osteotech, Inc. 219
4.65.1 Osteotech’s Products 219
4.65.2 Osteotech’s Business Segments 220
4.66 Pioneer Surgical Orthobiologics, Inc. 221
4.67 ProChon Biotech Ltd. 222
4.67.1 BioCart™ 222
4.68 Ranier Technology 222
4.68.1 Cadisc™-L 222
4.68.2 Cadisc™-C 223
4.69 ReGen Biologics, Inc. 223
4.69.1 Menaflex™ 223
4.70 RTI Biologics, Inc. 223
4.70.1 RTI’s Products and Distributors 224
4.71 Small Bone Innovations, Inc. 225
4.72 Smith & Nephew 226
4.73 SpinalKinetics™ 227
4.73.1 M6 Artificial Disc 227
4.74 Spinal Restorations, Inc. 228
4.74.1 Biostat System 228
4.75 Spine Smith, LP 228
4.76 Soft Tissue Regeneration, Inc. 228
4.76.1 STR’s Technology 228
4.77 Stryker Corporation 229
4.77.1 Stryker’s Product Sales 229
4.77.2 Stryker’s Orthopedic Implants 229
4.77.2.1 Stryker’s Hip Implant Systems 229
4.77.2.2 Stryker’s Primary Femoral Hip Systems 230
4.77.2.3 Stryker’s Primary Acetabular Systems 230
4.77.2.4 Stryker’s Revision Hip Systems 230
4.77.2.5 Stryker’s Resurfacing Hip Systems 230
4.77.2.6 Stryker’s Knee Implant Systems 230
4.77.2.7 Stryker’s Other Joint Replacement Products 231
4.77.2.8 Stryker’s Bone Cement 231
4.77.2.9 Stryker’s Trauma Implant Systems 231
4.77.2.10 Stryker’s Spinal Implant Systems 232
4.77.2.11 Craniomaxillofacial (CMF) Implant Systems 232
4.77.2.12 OP-1/BMP-7 232
4.77.3 Stryker’s MedSurge Equipments 233
4.77.4 Stryker’s Business Performance 234
4.78 Symmetry Medical, Inc. 234
4.78.1 Symmetry’s Products 234
4.78.1.1 Symmetry’s Implants 235
4.78.2 Symmetry’s Instruments 235
4.78.3 Symmetry’s Cases 235
4.78.4 Symmetry’s Customers 235
4.78.5 Symmetry’s Business Performance 235
4.79 Synovis Life Technologies, Inc. 236
4.79.1 Synovis’ Biomaterial Products 236
4.79.2 Synovis’ Microsurgery Products 237
4.80 Synthes, Inc. 237
4.80.1 Synthes’ Business Performance by Geography 237
4.80.2 Trauma Products from Synthes 238
4.81 ThermoGenesis Corporation 238
4.81.1 The AutoXpress Platform or AXP 239
4.81.2 The MarrowXpress™ 239
4.81.3 The BioArchive System 239
4.81.4 The Res-Q 60 BMC 239
4.81.5 Thermoline™ 239
4.81.6 The CryoSeal Fibrin Sealant (CryoSeal) System 239
4.82 TiGenix NV 239
4.82.1 ChondroCelect 240
4.82.2 Chondromimetic 240
4.82.3 TGX003 240
4.82.4 Stem Cells 240
4.83 TissueGene, Inc. 240
4.83.1 Tissue Gene’s Technology 240
4.84 Tissue Genesis, Inc. 241
4.84.1 Cell Isolation System™ 241
4.85 Tornier, Inc 241
4.86 TranS1 242
4.86.1 TranS1’s Solution 242
4.86.2 The Impressive Performance of TranS1’s Business 243
4.87 Velcura Therapeutics, Inc. 243
4.88 Vertebron 244
4.88.1 Vertebron PSS—Pedicle Screw System 244
4.88.2 Vertebron SSP Semi-Constrained Cervical Plate 244
4.88.3 ACIF-Anterior Cervical and PLIF-Posterior Lumbar (Allografts) 244
4.88.4 PEEK Vertical Body Replacements Devices 245
4.88.5 Cervical Motion Preservation (CMP) 245
4.89 Wright Medical Group, Inc. 245
4.89.1 Wright’s Products 245
4.89.2 Wright’s Business Performance 246
4.90 X-Spine Systems, Inc. 247
4.91 Xylos Corporation 248
4.91.1 Xylos’ Technology Applications in Musculoskeletal Disorders 248
4.92 Zimmer Holdings, Inc. 248
4.92.1 Zimmer’s Customers 248
4.92.2 Zimmer’s Products 249
4.92.2.1 NexGen Complete Knee Solution 249
4.92.2.2 Natural-Knee II System 250
4.92.2.3 Gender Solutions Natural-Knee Flex System 250
4.92.2.4 Innex Total Knee System 250
4.92.2.5 Zimmer Unicompartmental Knee Systems 250
4.92.2.6 Zimmer Patient-specific Instruments 250
4.92.2.7 Zimmer Segmental System 250
4.92.2.8 Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology 250
4.92.2.9 Alloclassic (Zweymuller) Hip System 250
4.92.2.10 CLS Spotorno Hip System 251
4.92.2.11 Fitmore Hip Stem 251
4.92.2.12 VerSys Hip System 251
4.92.2.13 Continuum Acetabular System, Trilogy IT Acetabular System and Allofit
IT Alloclassic Acetabular System 251
4.92.2.14 Zimmer MMC Cup 251
4.92.2.15 Trilogy Acetabular System 251
4.92.2.16 Bigliani/Flatow Complete Shoulder Solution Family 251
4.92.2.17 Trabecular Metal Glenoid 251
4.92.2.18 Trabecular Metal Reverse Shoulder System 252
4.92.2.19 Anatomical Shoulder System 252
4.92.2.20 Coonrad/Morrey Total Elbow 252
4.92.2.21 Tapered Screw-Vent Implant System 252
4.92.2.22 AdVent Implant System 252
4.92.2.23 Tapered SwissPlus Implant System 252
4.92.2.24 Zimmer Hex-Lock Contour Abutment and Restorative Products 252
4.92.2.25 Puros Allograft Products 252
4.92.2.26 Dynesys Dynamic Stabilization System 253
4.92.2.27 PathFinder Minimally-Invasive Pedicle Screw System 253
4.92.2.28 Sequoia Pedicle Screw System 253
4.92.2.29 Ardis Interbody System 253
4.92.2.30 Trinica Select Anterior Cervical Plating System 253
4.92.2.31 Biological Products 253
4.92.2.32 Wallis Posterior Dynamic Stabilization System 253
4.92.2.33 Zimmer Natural Nail System 254
4.92.2.34 NCB Polyaxial Locking Plate System 254
4.92.2.35 Zimmer Periarticular Locking Plate System 254
4.92.2.36 Zimmer Universal Locking System 254
4.92.2.37 Zimmer Cable-Ready System 254
4.92.2.38 Palacos Bone Cement 254
4.92.2.39 Hi-Fatigue Bone Cement 254
4.92.2.40 A.T.S Automatic Tourniquet Systems 254
4.92.2.41 Pulsavac Plus, Pulsavac Plus AC and Pulsavac Plus LP Wound Debridement
System 255
4.92.2.42 Zimmer Blood Reinfusion System (ZBRS) and Hemovac Blood Management
Systems 255
4.92.3 Zimmer’s Research and Development 255
Appendix 1: Osteoporosis 257
Appendix 1.1: Osteoporosis—General 257
Appendix 1.2: Osteoporosis in Men 257
Appendix 1.3: Hip Fracture 257
Appendix 1.4: Vertebral Fracture 258
Appendix 1.5: Key statistics for Europe 258
Appendix 1.6: Key statistics for North America 258
Appendix 1.7: Key statistics for Latin America 259
Appendix 1.8: Key statistics for Middle East/North Africa 259
Appendix 1.9: Key statistics for Asia 260
Appendix 1.10: Key statistics for Oceania 260
Appendix 2: Statistics and Facts about Orthopedics and Orthopedic Practices in
the U.S. 261
Appendix 3: Advances in Internal Bone Fixation 262
Appendix 3.1: Wires and Cables in Revision Surgery 262
Appendix 3.2: Problems from Broken Metal Cerclage Wires to Patients 263
Appendix 3.3: New Product Replacing Cerclage Cables 263
Appendix 4: Spinal Cord Injury Facts and Statistics 265
Appendix 5: Facts on Orthopedics, Clinical Trials, Regulatory and Reimbursement
Issues 267
Appendix 5.1: Clinical Trial Facts 267
Appendix 5.2: Clinical Trial Enrollment 268
Appendix 5.3: Clinical Trial Participants 269
Appendix 5.4: Clinical Trial Spending and Other Facts 269
Appendix 5.5: Musculoskeletal Pharma/Biologic Facts 270
Appendix 5.6: Regulatory Facts 270
Appendix 5.7: 510(k) Applications 270
Appendix 5.8: Investigational Device Exemption and Premarket Approval
Application (PMA) 271
Appendix 5.9: Reimbursement Facts 272
Appendix 5.9.1: National Healthcare Spending in the U.S. 272
Appendix 5.9.2: Reimbursement 272
Appendix 5.9.3: Medicare/Medicaid 273
Appendix 5.9.4: Insurance 273
Appendix 6: Medicare Rule and its Impact on Orthopedic Technology Firms 274
Appendix 6.1: Ills of the U.S. Orthopedics Market 275
Appendix 6.2: Current Orthopedics Business Environment 275


INDEX OF FIGURES

Figure 2.1: Trends in Implant Price, Physician and Hospital Medicare Payment,
1991 and 2010 32
Figure 2.2: Trend in Total and Femoral Resurfacing Hip Procedures, 2005-2009 36
Figure 2.3: Percent Market Share of Coated Hip Stems by Company, 2009 38
Figure 2.4: Percent Market Share of Uncoated Femur/Poly Liner Constructs by
Company, 2009 38
Figure 2.5: Percent of Cases by Construct Type, 2008 39
Figure 2.6: Percent Cases by Knee Implant Construct Type, 2008 41
Figure 2.7: Lumbar TDR Revenue, 2007-2015 54
Figure 2.8: Cervical TDR Revenue, 2007-2015 55
Figure 2.9: Common Primary Diagnoses Associated with Inpatient Decompression
Procedures 55
Figure 2.10: Percutaneous Discectomy Procedures by Site of Care 56
Figure 2.11: Percent Distribution of Spinal Deformity Diagnoses 57
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 64
Figure 2.17: Carpal Tunnel Syndrome Occurrences by Gender 65
Figure 2.18: Common Associated Diagnoses Treated by ESWT Procedure 68
Figure 3.1: Growth of North American Population Aged 65 and Over, 2010-2020 76
Figure 3.2: Growth of Western European Population Aged 65 and Over, 2010-2020 77
Figure 3.3: Life Expectancy in North America, 2010-2020 77
Figure 3.4: The Top Seven Medical Device Segments in the U.S., 2009 79
Figure 3.5: Percent Market Share of the Sub-Sectors of Orthopedics, 2009 80
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 Orthopedic Market by Geography, 2009 86
Figure 3.9: Global Market for Orthopedics, 2009-2016 87
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 89
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 111
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 121
Figure 3.41: Average Charges per Region 127
Figure 3.42: Payment Distribution in Total Knee Replacement 128
Figure 3.43: Growth of Endoscopic Surgery Products in the U.S., 2009-2014 128
Figure 3.44: U.S. Market for Orthopedic Biomaterials, 2009-2016 129
Figure 3.45: U.S. Market for Soft Tissue and Sports Medicine, 2009-2016 130
Figure 3.46: Percent of Orthopedic Surgeons by Sub-Specialties, 2009 131
Figure 3.47: U.S. Market for Orthopedic Braces and Supports, 2005 and 2009 131
Figure 3.48: Orthopedics Reconstructive Market Leaders in Europe, 2008 132
Figure 3.49: European Trauma Market Share by Company, 2008 132
Figure 3.50: The Size of Aging Population (65+) in Selected Countries, 2008 133
Figure 3.51: Prevalence of Arthritis in Selected Countries, 2008 134
Figure 3.52: Growth of Chinese Orthopedics Market, 2006-2009 134
Figure 4.1: Alphatec’s Business Performance, 2005-2009 142
Figure 4.2: Biomet’s Percent Business Performance by Product Category, 2009 159
Figure 4.3: Conmed’s Business Performance, 2005-2009 170
Figure 4.4: Exactech’s Overall Business Performance, 2005-2009 185
Figure 4.5: Integra’s Overall Business Performance, 2005-2009 195
Figure 4.6: Medtronic’s Percent Revenue by Operating Segments, 2010 206
Figure 4.7: NuVasive’s Business Growth, 2005-2009 212
Figure 4.8: Orthofix’s Overall Business Performance, 2005-2009 215
Figure 4.9: Orthovita’s Business Performance, 2005-2009 218
Figure 4.10: Stryker’s Overall Business Performance, 2005-2009 234
Figure 4.11: Synthes’ Percent Market Share by Geography, 2009 238
Figure 4.12: TranS1’s Impressive Growth in Business, 2005-2009 243
Figure 4.13: Wright’s Overall Business Performance, 2005-2009 247
Figure 4.14: Zimmer’s Percent Business Performance by Geography, 2009 249
Figure A5.1: Share of Clinical Trial Funding by Source, 2009 267
Figure A5.2: Clinical Study Participant’s Primary Concerns 268
Figure A5.3: Factors Impacting Clinical Study Participation 269
Figure A5.4: Capital Raised by Device Companies for PMA and 510k Approvals,
2005-2009 271
Figure A5.5: Total FDA PMA Submissions and Approvals, 2004-2009 271
Figure A6.1: Percent Change in Medicare Payment According to 2010 IPPS Rule 274
Figure A6.2: Economic Inequality Between Orthopedic Surgeon and Sales
Representative, 2009 276
Figure A6.3: Percent Generic and Brand Name Prescriptions, 1984 and 2009 276


INDEX OF TABLES

Table 2.1: Selected Hip Products from the Top Two Market Leaders 24
Table 2.2: The Most Common Large Joint Disorders: Disorders of the Hip 26
Table 2.3: The Available Viscosupplements in the Market 29
Table 2.4: Injections and Following Procedures, 2004 and 2005 30
Table 2.5: Cost of Synovial Injections 30
Table 2.6: Knee Products from the Zimmer 31
Table 2.7: Change in Hip and Knee Implant List Prices, 2009 and 2010 33
Table 2.8: Total Hips/Resurfacing Prices by Manufacturer and Implant Type, 2009
33
Table 2.9: Partial Hips Prices by Manufacturer and Implant Type, 2009 34
Table 2.10: Knees Prices by Manufacturer and Implant Type, 2009 34
Table 2.11: Case Share of Total Hip Implant Assemblies, 2009 35
Table 2.12: Change in Femoral Resurfacing List Prices, 2009 and 2010 35
Table 2.13: Change in Metal-on-Metal Hip Implant List Prices, 2009 and 2010 36
Table 2.14: Change in Ceramic-on-Ceramic List Prices, 2009 and 2010 37
Table 2.15: Change in Coated Stem Poly Liner Hip Implant List Price, 2009 and
2010 37
Table 2.16: Case Shares of Partial Hip Implant Assemblies, 2009 39
Table 2.17: Change in Bipolar Hip Implant List prices, 2009 and 2010 40
Table 2.18: Change in Modular Endoprostheses List Prices, 2009 and 2010 40
Table 2.19: Change in Coated Knee Implant List Prices, 2009 and 2010 41
Table 2.20: Change in Uncoated Knee Implant List Prices, 2009 and 2010 42
Table 2.21: Change in Hybrid Knee Implant List Prices, 2009 and 2010 42
Table 2.22: Change in Knee with All Poly Tibia List Prices, 2009 and 2010 43
Table 2.23: Change in Unicondylar Knee Implant List Prices, 2009 and 2010 43
Table 2.24: Top Five Shoulder-related Diagnoses and the Baby Boomer Population
46
Table 2.25: Pedicle-based Motion Preservation Devices and Their Indications 49
Table 2.26: Primary Inpatient Diagnoses of Spinal Disorders 49
Table 2.27: Average Reimbursement for Spine Indications 50
Table 2.28: Spinal Procedure Reimbursements 50
Table 2.29: Common Providers of Posterior Lumbar Fusion in Elderly Patients 51
Table 2.30: VCF Treatment by Site of Care and Levels Treated 51
Table 2.31: Age Ranges of the Most Common Spine Diagnoses 52
Table 2.32: Procedure Volumes for Patients More Than 64 Years of Age, 2007 and
2009 53
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 62
Table 2.36: Procedures for Treating Plantar Fascial Fibromatosis 63
Table 2.37: Percent Treatment Options for Tennis Elbow 66
Table 2.38: Most Common Fracture Diagnoses in Extremities, 2004-2007 66
Table 2.39: Bone Graft Substitutes 69
Table 3.1: Musculoskeletal Diagnoses Delineated by Age 78
Table 3.2: Global Orthopedic Product Sales by Market Segment and Geography, 2009
81
Table 3.3: Key Market Players in Orthopedic Implants 81
Table 3.4: Orthopedic Companies with Their Sales and Product Lines, 2009 82
Table 3.5: Global Market for Orthopedics by Product Segment, 2009 83
Table 3.6: Global Orthopedics Market by Company, 2009 85
Table 3.7: Global Orthopedic Market by Geography, 2009 86
Table 3.8: Global Market for Non-Invasive Orthopedics, 2009 100
Table 3.9: Orthopedics Companies (Excluding Spine and Hip/Knee) and Funding
Received, 2008 101
Table 3.10: U.S. Healthcare Spending vs. Orthopedics Breakout, 2000-2009 103
Table 3.11: Industry EBITDA Margins, 2009 104
Table 3.12: The Differences Between Pharma and Orthopedic Product Cycles 105
Table 3.13: Spinal Products launched or in Clinical Studies in the last few
years 110
Table 3.14: Spine Company Market Share by Company, 2010 112
Table 3.15: Spine Implant and Related Biologics Industry Revenue, 2007-2012 112
Table 3.16: Spine Company Market Share, 2007-2012 113
Table 3.17: Reimbursement for Spinal Procedures, 2008-2010 114
Table 3.18: The Aging Spine in the U.S. Population, 2010-2050 115
Table 3.19: Spine Disorders as a Percentage of Common Diagnoses 116
Table 3.20: Quarterly and Estimated Annual Sales Revenue for Spine Product
Companies, 2008-2010 118
Table 3.21: Primary Inpatient Diagnoses 119
Table 3.22: Average Reimbursement for Spine Indications 120
Table 3.23: Procedure Reimbursement 120
Table 3.24: Common Providers of Post Lumbar Fusions in Aged Patients (ICD-9 Code
81.08) 122
Table 3.25: Artificial Disc Landscape 123
Table 3.26: Facet and Nucleus Replacement Landscape 124
Table 3.27: Dynamic Stabilization Landscape 124
Table 3.28: State TKA Rank by Volume in the U.S. 126
Table 3.29: U.S. Market for Bone Graft Substitutes, 2008 and 2009 129
Table 3.30: Leading Players of Orthopedics in China, 2009 135
Table 3.31: Leading Players in Spine Market in China, 2009 135
Table 4.1: Alphatec’s Current Products, 2009 141
Table 4.2: Products from U.S. Spine 145
Table 4.3: Artimplant’s Products and Projects, 2009 147
Table 4.4: ArthoCare’s Sports Medicine Products 148
Table 4.5: Biocomposites Ltd.’s Products 155
Table 4.6: Products from Bacterin International, Inc. 155
Table 4.7: BioMimetic’s Clinical Study Programs and Product Candidates, 2009 156
Table 4.8: Advantages and Disadvantages of Current Therapies 157
Table 4.9: BoneSupport’s Products 158
Table 4.10: Biomet’s Business Performance by Geography, 2007-2009 162
Table 4.11: Biomet’s Business Performance by Product Category, 2007-2009 162
Table 4.12: Conmed’s Arthroscopy Products, 2009 166
Table 4.13: Conmed’s Powered Surgical Instruments, 2009 167
Table 4.14: Conmed’s Electrosurgery Products, 2009 168
Table 4.15: Conmed’s Patient Care Products, 2009 168
Table 4.16: Conmed’s Endosurgery Products, 2009 169
Table 4.17: Conmed’s Endoscopy Products, 2009 169
Table 4.18: Corin’s Business Performance by Geography and Product Type, 2008 and
2009 172
Table 4.19: DePuy’s Other Products in Orthopedics 174
Table 4.20: DJOFL’s Domestic Rehabilitation Products, 2009 181
Table 4.21: DJOFL’s Domestic Surgical Implant Products, 2009 181
Table 4.22: DJOFL’s Business Performance, 2008 and 2009 182
Table 4.23: Orthopedic Products from Etex 182
Table 4.24: Exactech’s Business Performance by Product Line, 2007-2009 183
Table 4.25: Overview of Genzyme’s Biosurgery Products 186
Table 4.26: Genzymes Business in Biosurgery Products, 2008 and 2009 187
Table 4.27: Geron’s hESC-derived Product Candidates for Orthopedic Applications
187
Table 4.28: Globus’ Product Portfolio 187
Table 4.29: GMReis’ Spine, Orthopedic and Biologic Products 190
Table 4.30: Products from Graftys SA 192
Table 4.31: Inion’s Product Portfolio 192
Table 4.32: Integra’s Revenue by Business Segment, 2007-2009 195
Table 4.33: Products from Interventional Spine 196
Table 4.34: Orthopedic Products from K2M 197
Table 4.35: Products from Kasios 198
Table 4.36: Kensey Nash’s Orthopedic Products 198
Table 4.37: Kyphon’s Orthopedic Products 199
Table 4.38: Products from Lanx 200
Table 4.39: Orthopedic Products from LifeSpine 203
Table 4.40: Medartis’ Product Portfolio 204
Table 4.41: Medtronic’s Net Sales of Spinal Products, 2008-2010 206
Table 4.42: Mekanika’s Products 207
Table 4.43: Nanotherapeutics’ Product Pipeline 209
Table 4.44: Products from Olympus Terumo Biomaterial Corporation 212
Table 4.45: Orthofix’s Business Performance by Business Segment, 2007-2009 213
Table 4.46: Orthofix’s Business Performance by Product type, 2007-2009 214
Table 4.47: Orthofix’s Products and Primary Applications 214
Table 4.48: Orthovita’s Patented Products, 2010 217
Table 4.49: Ossur’s Business Performance by Geography, 2009 219
Table 4.50: Osteotech’s Products 220
Table 4.51: Osteotech’s Business by Business Segment, 2007-2009 220
Table 4.52: Osteotech’s Business by Geography, 2007-2009 221
Table 4.53: Overview of Pioneer’s Spine Products 221
Table 4.54: RTI’s Business Performance, 2007-2009 224
Table 4.55: RTI’s Products and Distributors 224
Table 4.56: Orthopedic Products from Small Bone Innovations 225
Table 4.57: Smith & Nephew’s Orthopedic Products 227
Table 4.58: Spine Smith’s Product Portfolio 228
Table 4.59: Stryker’s Business Performance by Domestic/International/Business
Segment, 2007-2009 229
Table 4.60: Symmetry’s Business Performance by Product Category, 2008 and 2009
236
Table 4.61: Synovis’ Business Performance by Product Line, 2007-2009 236
Table 4.62: Synthes’ Business Performance by Geography, 2009 237
Table 4.63: Products from Tornier, Inc. 241
Table 4.64: Velcura’s Product Pipeline 243
Table 4.65: Wright’s Products, 2009 245
Table 4.66: Wright’s Business Performance by Product Line, 2008 and 2009 246
Table 4.67: X-Spine’s Orthopedic Products 247
Table 4.68: Zimmer’s Orthopedics Business by Geography, 2005-2009 249
Table 4.69: Zimmer’s Global Business by Product Category and Region, 2008 and
2009 255
Table 4.70: Global Market and Zimmer’s Market Share, 2009 256
Table A3.1: Number of Hip Arthroplasties in the U.S., 2010 and 2030 263
Table A3.2: Number of Fractures during Hip Replacement Surgeries, 2010 and 2030
264
Table A3.3: Number of Fractures in the U.S., 2006 264