Table of Contents
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 14
1.2 List of Figures 18
2 Introduction 21
2.1 What is This Report
About? 21
3 Definitions of Markets Covered in the Report 22
3.1
Orthopedic Devices 22
3.2 Orthobiologics 22
3.2.1 Bone Allografts
22
3.2.2 Bone Graft Substitutes 22
3.2.3 Bone Growth and Spinal
Stimulation 22
3.2.4 Viscosupplementation 22
3.2.5 DBM 22
3.3
Joint Reconstruction 23
3.3.1 Ankle Replacement 23
3.3.2 Digits
Replacement 23
3.3.3 Elbow Replacement 23
3.3.4 Hip Replacement 23
3.3.5 Knee Replacement 24
3.3.6 Shoulder Replacement 24
3.3.7 Wrist
Replacement 25
3.4 Spinal Surgery 25
3.4.1 Spinal Fusion 25
3.4.2
Spinal Non-Fusion 25
3.5 Trauma Fixation 26
3.5.1 Internal Fixators
26
3.5.2 External Fixators 26
3.6 Arthroscopy 27
3.6.1 Arthroscope
27
3.7 Orthopedic Accessories 27
3.7.1 Bone Cement 27
3.7.2 Cast
Application and Removal Systems 27
3.8 Orthopedic Braces and Supports
27
3.8.1 Ankle Braces and Supports 27
3.8.2 Knee Braces and Supports
27
3.8.3 Wrist and other Braces and Supports 27
4 Healthcare Sector
Review 28
4.1 Healthcare Expenditure 28
4.2 Healthcare Infrastructure
30
4.2.1 Healthcare Personnel Data 32
4.3 United States Healthcare
Trade Statistics 34
5 Regulation System 35
5.1 Regulation System
35
5.2 Medical Equipment Approval Process 35
5.2.1 Pre-market Approval
Process 36
5.2.2 Intended use and Indications for use 36
5.2.3
Predicate Device 37
5.2.4 Safe and Effective 37
5.2.5 Other Category
Devices 39
5.2.6 Post-Market Approval Process 40
5.2.7 Compliance and
Enforcement 40
5.2.8 Registration Fee 41
5.2.9 Approval Time 41
6
Pricing and Reimbursement 42
6.1 Government Policies 42
6.2 Private
Insurance 43
6.3 Diagnosis Related Groups (DRG) 44
7 Distribution
Structure 45
7.1 Distribution Structure 45
8 Orthopedic Devices In
United States 46
8.1 Orthopedic Devices, Cross Country Comparison, Revenue
($ mn), 2000-2015 46
8.2 Orthopedic Devices, United States, Overall
Revenue ($ mn), 2000-2015 47
8.3 Orthopedic Devices, United States,
Category Volume (Units), 2000-2015 51
8.4 Orthopedic Devices, United
States, Company Share (2007-2008) 56
9 Arthroscopy In United States 57
9.1 Arthroscopy Overall Revenue (2000-2015) 57
9.2 Arthroscopy Overall
Volume (2000-2015) 59
9.3 Arthroscopy Average Price (2000-2015) 61
9.4
Arthroscopy Distribution Share (2007-2008) 61
9.5 Arthroscopy, United
States, Company Share (2007-2008) 62
10 Joint Reconstruction In United
States 63
10.1 Joint Reconstruction Overall Revenue (2000-2015) 63
10.1.1 Hip Replacement Overall Revenue (2000-2015) 65
10.1.2 Knee
Replacement Overall Revenue (2000-2015) 67
10.1.3 Shoulder Replacement
Overall Revenue (2000-2015) 69
10.2 Joint Reconstruction Overall Volume
(2000-2015) 71
10.2.1 Hip Replacement Overall Volume (2000-2015) 73
10.2.2 Knee Replacement Overall Volume (2000-2015) 75
10.2.3 Shoulder
Replacement Overall Volume (2000-2015) 77
10.3 Joint Reconstruction
Average Price (2000-2015) 79
10.4 Joint Reconstruction Distribution Share
(2007-2008) 81
10.5 Joint Reconstruction, United States, Company Share
(2007-2008) 82
11 Orthobiologics In United States 83
11.1
Orthobiologics Overall Revenue (2000-2015) 83
11.1.1 Bone Graft
Substitutes Overall Revenue (2000-2015) 85
11.2 Orthobiologics Overall
Volume (2000-2015) 87
11.2.1 Bone Graft Substitutes Overall Volume
(2000-2015) 89
11.3 Orthobiologics Average Price (2000-2015) 91
11.4
Orthobiologics Distribution Share (2007-2008) 92
11.5 Orthobiologics,
United States, Company Share (2007-2008) 93
12 Orthopedic Accessories In
United States 95
12.1 Orthopedic Accessories Overall Revenue (2000-2015)
95
12.2 Orthopedic Accessories Overall Volume (2000-2015) 97
12.3
Orthopedic Accessories Average Price (2000-2015) 99
12.4 Orthopedic
Accessories Distribution Share (2007-2008) 100
12.5 Orthopedic
Accessories, United States, Company Share (2007-2008) 101
13 Orthopedic
Braces and Supports In United States 102
13.1 Orthopedic Braces and
Supports Overall Revenue (2000-2015) 102
13.2 Orthopedic Braces and
Supports Overall Volume (2000-2015) 104
13.3 Orthopedic Braces and
Supports Average Price (2000-2015) 106
13.4 Orthopedic Braces and Supports
Distribution Share (2007-2008) 107
13.5 Orthopedic Braces and Supports,
United States, Company Share (2007-2008) 108
14 Spinal Surgery In United
States 109
14.1 Spinal Surgery Overall Revenue (2000-2015) 109
14.1.1
Spinal Fusion Overall Revenue (2000-2015) 111
14.1.2 Spinal Non-Fusion
Overall Revenue (2000-2015) 113
14.2 Spinal Surgery Overall Volume
(2000-2015) 115
14.2.1 Spinal Fusion Overall Volume (2000-2015) 117
14.2.2 Spinal Non-Fusion Overall Volume (2000-2015) 119
14.3 Spinal
Surgery Average Price (2000-2015) 121
14.4 Spinal Surgery Distribution
Share (2007-2008) 122
14.5 Spinal Surgery, United States, Company Share
(2007-2008) 123
15 Trauma Fixation In United States 124
15.1 Trauma
Fixation Overall Revenue (2000-2015) 124
15.1.1 Internal Fixators Overall
Revenue (2000-2015) 126
15.2 Trauma Fixation Overall Volume (2000-2015)
128
15.2.1 Internal Fixators Overall Volume (2000-2015) 129
15.3
Trauma Fixation Average Price (2000-2015) 131
15.4 Trauma Fixation
Distribution Share (2007-2008) 132
15.5 Trauma Fixation, United States,
Company Share (2007-2008) 133
16 Overview of Key Companies in United
States Orthopedic Devices Market 134
16.1 DePuy, Inc. 134
16.1.1
Company Overview 134
16.1.2 DePuy, Inc. Pipeline Products 134
16.2
Stryker Corporation 137
16.2.1 Company Overview 137
16.2.2 Value Chain
Analysis 137
16.2.3 Stryker Corporation Pipeline Products 139
16.3
Zimmer Holdings, Inc. 141
16.3.1 Company Overview 141
16.3.2 Value
Chain Analysis 142
16.3.3 Zimmer Holdings, Inc. Pipeline Products 144
16.4 Medtronic, Inc. 146
16.4.1 Company Overview 146
16.4.2 Value
Chain Analysis 146
16.4.3 Medtronic, Inc. Pipeline Products 148
16.5
Synthes GmbH 156
16.5.1 Company Overview 156
16.5.2 Value Chain
Analysis 157
16.5.3 Synthes, Inc. Pipeline Products 158
16.6 Smith &
Nephew Plc 160
16.6.1 Company Overview 160
16.6.2 Value Chain Analysis
161
16.6.3 Smith & Nephew Plc Pipeline Products 163
16.7 Biomet, Inc.
165
16.7.1 Company Overview 165
16.7.2 Value Chain Analysis 166
16.7.3 Biomet, Inc. Pipeline Products 168
16.8 Arthrex, Inc. 170
16.8.1 Company Overview 170
16.9 BREG Incorporated 170
16.9.1 Company
Overview 170
16.10 Arthrocare Corporation 171
16.10.1 Company Overview
171
16.10.2 Value Chain Analysis 172
16.10.3 Arthrocare Corporation
Pipeline Products 174
16.11 CONMED Corporation 176
16.11.1 Company
Overview 176
16.11.2 Value Chain Analysis 176
16.12 Genzyme
Corporation 178
16.12.1 Company Overview 178
16.12.2 Genzyme
Corporation Pipeline Products 178
16.13 Osteotech, Inc. 181
16.13.1
Company Overview 181
16.13.2 Osteotech, Inc. Pipeline Products 181
16.14 Hanger Orthopedic Group, Inc. 183
16.14.1 Company Overview 183
16.14.2 Value Chain Analysis 183
16.15 Orthofix International N.V. 186
16.15.1 Company Overview 186
16.15.2 Value Chain Analysis 186
16.15.3
Orthofix International N.V. Pipeline Products 188
16.16 DJO Incorporated
190
16.16.1 Company Overview 190
16.16.2 Value Chain Analysis 190
16.17 Johnson & Johnson 193
16.17.1 Company Overview 193
16.17.2 Value
Chain Analysis 193
16.18 DeRoyal Industries, Inc. 196
16.18.1 Company
Overview 196
16.19 Anchor Products Co., Inc. 196
16.19.1 Company
Overview 196
17 Financial Deals Landscape 197
17.1 Acquisition 197
17.1.1 NuVasive To Acquire Cervitech 197
17.1.2 Arkema Acquires Oxford
Performance Materials 198
17.1.3 Michigan Orthopedic Services Acquires O&P
Professional Care 199
17.1.4 Hanger Orthopedic Group Completes Six
Acquisitions 200
17.1.5 Advanced Technology Acquisition To Acquire Bioness
201
17.1.6 NovaMed Acquires Majority Interest In Physicians Surgical
Center 202
17.2 Partnerships 203
17.2.1 Tornier Enters Into Licensing
Agreement With T.A.G. Medical Products 203
17.2.2 DJO Surgical Signs An
Agreement With LimaGroup 204
17.2.3 RTI Biologics Enters Into An Agreement
With Aesculap Implant Systems 205
17.2.4 StemCor Systems Enters Into An
Agreement With Hospira 206
17.2.5 NeuralStem Enters Into An Agreement With
The Cleveland Clinic 207
18 Recent Developments 208
18.1 Strategy and
Business Planning 208
18.1.1 May 21, 2009: Johnson & Johnson Acquires
Cougar For $1b 208
18.1.2 May 11, 2009: Medtronic Announces San Antonio As
Home Of New Diabetes Facility 208
18.1.3 Mar 25, 2009: Medtronic Leases
Nearly 50,000 Square-Foot Facility For Ablation Frontiers Unit 209
18.1.4
Mar 02, 2009: CUREXO Technology Corporation Announces New Headquarters 210
18.1.5 Feb 24, 2009: Medtronic Plans To Reduce Global Workforce 210
18.1.6
Feb 10, 2009: Orthofix Plans To Close Its Huntersville, Facility 210
18.1.7 Jan 30, 2009: Codman Plans To Close Its Manufacturing Operations In
Miami Lakes 210
18.1.8 Jan 30, 2009: Smith & Nephew Signs Grant
Administration Agreement With OREF 211
18.1.9 Dec 31, 2008: Wright Medical
Plans To Unveil New Devices In 2009 211
18.1.10 Dec 17, 2008: Teleflex
Plans To Consolidate Commercial Segment Operations 212
18.1.11 Nov 06,
2008: Orthofix Announces Restructuring Plan For Blackstone 212
18.1.12 Nov
01, 2008: Greatbatch Plans To Close Three Facilities 212
18.2 Legal and
Regulatory 213
18.2.1 May 20, 2009: Wright Medical To Settle Bulk Of
Biologic Products Lawsuits 213
18.2.2 May 11, 2009: Stryker Receives
Subpoena From New Jersey Attorney General 213
18.2.3 May 11, 2009: Biomet
To Settle Bulk Of Bone Stimulator Lawsuits 214
18.2.4 May 05, 2009:
Synthes Settles With New Jersey Attorney General And Agrees To Reimburse
Investigation Costs Of $236,000 214
18.2.5 Apr 27, 2009: Zynex CEO
Responds To Class-Action Lawsuits 215
18.2.6 Apr 16, 2009: Smith & Nephew
Recieves Subpoena From DOJ 215
18.2.7 Apr 15, 2009: DJO Announces
Unsealing Of False Claims Act Complaint Against Bone Growth Stimulator
Manufacturers 215
18.2.8 Apr 03, 2009: Rosen Law Firm Announces
Investigation of Federal Securities Fraud Claims Against Zynex 216
18.2.9
Mar 30, 2009: Implant Sciences Settles Lawsuit With Evans 216
18.2.10 Mar
30, 2009: Smith & Nephew Orthopaedics Announces End Of DPA And Dismissal Of
Complaint By USAO 216
18.2.11 Mar 30, 2009: DOJ Dismisses Charges Against
Orthopedic Device Makers 217
18.2.12 Mar 11, 2009: Medtronic Announces
Dismissal Of Lawsuit 217
18.2.13 Mar 10, 2009: Stryker Biotech Unit Faces
Federal Investigation In Massachusetts 217
18.2.14 Feb 18, 2009:
ArthroCare Announces Investigations By SEC And US Attorney Offices 217
18.2.15 Jan 06, 2009: Court Rules In Favor Of Medtronic In Fidelis Litigation
218
18.3 Government and Public Interest 218
18.3.1 Apr 29, 2009:
Justice Department Investigates Devicemakers For Improper Billing 218
18.3.2 Apr 09, 2009: Rush University Medical Center Tests New Surgical
Procedure For Regenerating Cartilage In Damaged Knee Joints 218
18.3.3 Apr
02, 2009: FDA To Study Long-Term Safety Of Joint Replacement Devices 219
18.3.4 Mar 05, 2009: AdvaMed Sets New Advertising Rules 219
18.3.5 Feb 03,
2009: University Responds To Probe, Orthopedic Industry Cautious 220
18.4
Product News 220
18.4.1 May 20, 2009: Smith & Nephew' s Endoscopy Announces
The Launch Of BICEPTOR Tenodesis System, The First All-Arthroscopic Procedure
For Biceps Tendon Repair 220
18.4.2 May 12, 2009: Disc Motion Technologies
Announces The First Surgical Procedure Using Inlign Multi-Level Hybrid System
221
18.4.3 May 12, 2009: FDA To Review Approval Of Menaflex 221
18.4.4
May 07, 2009: CONMED Releases Paladin Rotator Cuff Suture Anchor 222
18.4.5 May 05, 2009: Integra LifeSciences Announces The Launch Of Coral
Extended Tab Spinal Screw Series 222
18.4.6 May 05, 2009: Limited Market
Release Of Orthofix International' s Trinity Evolution 223
18.4.7 May 04,
2009: Alphatec Spine Launches GLIF (Guided Lateral Interbody Fusion) Technique
And ARC Portal Access System At AANS 223
18.4.8 May 04, 2009: CoreSpine
Technologies' XTEND-ST Nucleus Removal System Receives 510(k) Clearance
223
18.4.9 May 04, 2009: Medtronic Launches PEEK PREVAIL Device For Neck
Surgery 224
18.4.10 May 04, 2009: Medtronic Launches VERTEX SELECT
Reconstruction System Occipitocervical Module 224
18.4.11 May 04, 2009:
X-spine' s Calix Spinal Implant System Receives FDA Clearance 225
18.4.12
Apr 28, 2009: Depuy Spine Announces The Launch Of Healos Fx Injectable Bone
Graft Replacement For Minimally Invasive Spine Procedures 225
18.4.13 Apr
27, 2009: FDA Clears ETEX Corporation' s Small Size Beta-bsm Injectable Paste
And Gamma-bsm Moldable Putty 225
18.4.14 Apr 27, 2009: New Clinical Data
Of ApaTech' s Actifuse Shows Promising Results In Spinal Fusion Surgery 226
18.4.15 Apr 22, 2009: US FDA Approves MiMedx Group' s Paradis Vaso Shield
Device 226
18.4.16 Apr 20, 2009: Interventional Spine Starts Clinical
Study Using PDS System For Percutaneous Treatment Of Degenerative Disc Disease
In The US 227
18.4.17 Apr 20, 2009: ReGen Biologics Announces US Surgeons
Successfully Completes Menaflex Surgery 227
18.4.18 Apr 16, 2009: DJO
Incorporated To Launch Intelect SWD Shortwave Diathermy Device In US 227
18.4.19 Apr 16, 2009: DJO Receives FDA 510(k) Clearance For Intelect SWD
Shortwave Diathermy Device 228
18.4.20 Apr 08, 2009: Core Essence
Announces 510(k) Clearance For SECURUS Suture Anchor System 228
18.4.21
Apr 02, 2009: LDR Corporation Receives US FDA Approval For Its ROI-A ALIF
Device 229
18.4.22 Apr 01, 2009: Orthovita Submits Additional Data To FDA
In Support Of Its 510 (k) Application For The Use Of CORTOSS Bone Augmentation
Material 229
18.4.23 Mar 31, 2009: AOI Medical Announces Successful
Completion Of Thirty Procedures In Clinical Trial Using Ascendx VCF Reduction
System 230
18.4.24 Mar 31, 2009: AOI Medical Plans To Launch Ascendx VCF
Reduction System 230
18.4.25 Mar 18, 2009: Harvard Clinical Study Turns
Favourable For Cayenne Medical' s AperFix Technology For Reconstruction Of Torn
ACL 230
18.4.26 Mar 06, 2009: Surgeons Use US Spine' s Lock-Tight Device
For Minimally Invasive Spine Fixation Surgery 231
18.4.27 Mar 04, 2009:
Small Bone Innovations Receives FDA Approvable Letter For S.T.A.R. Total Ankle
Replacement System 231
18.4.28 Feb 27, 2009: Smith & Nephew Announces The
Introduction Of Metal Liner Option For The Modular R3 Acetabular Cup System
232
18.4.29 Feb 26, 2009: Genzyme Announces FDA Approval For Synvisc-One
For Osteoarthritis Of The Knee 232
18.4.30 Feb 26, 2009: Globus Medical
Announces The Full Launch Of INDEPENDENCE Spacer System 233
18.4.31 Feb
25, 2009: DePuy Orthopaedics Introduces New Metal Head For Hip, Significantly
Reduces Wear And Potential For Ion Release 233
18.4.32 Feb 25, 2009: DePuy
Orthopaedics Sigma Knee Portfolio Advances Options With New High Flexion
Partial And Total Knee Solutions 234
18.4.33 Feb 25, 2009: DePuy
Orthopaedics' Anatomic Locked Plating Systems (A.L.P.S.) For Trauma Available
For Hand And Distal Fibula Fractures 235
18.4.34 Feb 25, 2009: DePuy
Orthopaedics' Anatomic Locked Plating Systems (A.L.P.S.) For Trauma Available
For Hand And Distal Fibula Fractures 236
18.4.35 Feb 25, 2009: DePuy
Orthopaedics' Sigma Knee Portfolio Advances Options With New High Flexion
Partial And Total Knee Solutions 237
18.4.36 Feb 25, 2009: KFx Medical
Corporation Develops New Innovative System To Repair Rotator Cuff Tears
238
18.4.37 Feb 25, 2009: Smith & Nephew Endoscopy' s OSTEORAPTOR Anchor
Provides Bioabsorbable Solution For Labral Tears In The Hip And Shoulder
238
18.4.38 Feb 25, 2009: Zimmer Exhibits Trabecular Metal Technology At
AAOS Annual Meeting 239
18.4.39 Feb 25, 2009: Zimmer' s Trabecular Metal
Technology Shows Significant Bone In-growth And Advanced Clinical Outcomes In
A Comparative Study 239
18.4.40 Feb 24, 2009: Alphatec Spine To Unveil
OsseoFix+ Cement System And VIP System 239
18.4.41 Feb 24, 2009: Axiom
Worldwide Presents Published Data Of DRX9000 Study 240
18.4.42 Feb 24,
2009: Bone Biologics Completes Primate Trials Using Recombinant Protein And
Demineralized Bone Matrix For Spinal Fusion Surgery 240
18.4.43 Feb 24,
2009: IlluminOss Medical' s Photodynamic Bone Stabilization System Treats First
Human Case At Medical Hospital del Trabajadar In Santiago 240
18.4.44 Feb
24, 2009: Kensey Nash Submits IDE Application For Cartilage Repair Device To
FDA 240
18.4.45 Feb 24, 2009: MAKO Surgical Unveils Next Generation
Robotic Arm And Implants 241
18.4.46 Feb 24, 2009: USPTO Issues Patent For
Exactech' s Rotating Bearing Knee, Optetrak RBK System 241
18.4.47 Feb 23,
2009: Alphatec Spine To Develop Interspinous Devices To Treat Lumbar Spinal
Stenosis 242
18.4.48 Feb 23, 2009: Alphatec Spine To Develop Interspinous
Devices To Treat Lumbar Spinal Stenosis 242
18.4.49 Feb 23, 2009: Exactech
Extends Development License With Hospital For Total Knee Replacement Surgery
242
18.4.50 Feb 23, 2009: Exactech To Showcase New Prosthetic Products At
The AAOS Meeting 243
18.4.51 Feb 23, 2009: Smith & Nephew Introduces
Patient Matched Technology VISIONAIRE For Total Knee Replacement 243
18.4.52 Feb 18, 2009: Cardo Medical Announces Femur-First Versatility In
Surgical Technique With Its Align 360 Uni-Compartmental Knee System 243
18.4.53 Feb 18, 2009: Cardo Medical Introduces New Features For Align 360
Uni-Compartmental Knee System 244
18.4.54 Feb 11, 2009: Orthofix
International Accelerate The Launch Date For Trinity Evolution 244
18.4.55
Feb 10, 2009: US FDA Grants 510(k) Clearance For K2M' s tifix CAYMAN Plate
Systems 245
18.4.56 Feb 04, 2009: BioCleanse Meniscus Study Illustrates
Similar Performance Compared To Aseptically Processed Allograft In Sheep Model
245
18.4.57 Feb 03, 2009: Globus Medical Introduces PATRIOT SIGNATURE TLIF
Spacer System 246
18.4.58 Feb 02, 2009: Innovative Implant Technology' s
New Sinu-Lift System Replaces Osteotome And Mallet Technique 246
18.4.59
Feb 02, 2009: NIMS Receives FDA Approval To Market Exer-Rest 246
18.4.60
Jan 26, 2009: DiFUSION Technologies Finishes Successful Testing Of CleanFUZE
247
18.4.61 Jan 23, 2009: Norwalk Hospital To Participate In Globus
Medical' s Clinical Trial For Treatment Of Lumbar Spinal Stenosis 247
18.4.62 Jan 22, 2009: Cardo Medical Announces Initial Release Of Press-Fit
Total Hip System 248
18.4.63 Jan 12, 2009: OsseoFix Training Sessions To
Accelerate Commercial Use In Europe 248
18.4.64 Jan 12, 2009: Regen
Biologics Announces Launch Of Menaflex Collagen Meniscus Implant At American
Academy Of Orthopaedic Surgeons 248
18.4.65 Jan 09, 2009: Integra
LifeSciences Launches Vu e-POD And Vu L-POD 249
18.4.66 Jan 07, 2009:
BioMimetic Therapeutics Inc Closes Enrollment Of The Pivotal Study For Augment
Bone Graft With 436 Patients 249
18.4.67 Jan 06, 2009: DiFusion
Technologies Making Spinal Infection Fighter 250
18.5 Other Significant
Developments 250
18.5.1 May 20, 2009: Cholesterol Drug Mipomersen' Trial
Attains Objective 250
18.5.2 May 18, 2009: FDA Approves Johnson &
Johnson' s Drug For Bipolar I Disorder 251
18.5.3 May 15, 2009: Smith &
Nephew Orthopaedics Announces First Contribution To OREF Grants Fund 251
18.5.4 Apr 21, 2009: Orthofix Division Signs Expanded Supply Agreement With
Novation 252
18.5.5 Apr 13, 2009: Smith & Nephew To Close Down San Antonio
Facility By End Of 2009 252
18.5.6 Apr 09, 2009: FDA Review Of Medical
Devices Likely Won' t Affect Sales: Medtronic 253
18.5.7 Apr 07, 2009: The
Medtronic Foundation Awards Fourth grant To The NPF' s National Parkinson Care
Network Program 254
18.5.8 Apr 07, 2009: ReGen Biologics Donates $50,000
To New Jersey Democrats 255
18.5.9 Apr 01, 2009: FLA Orthopedics To Move
Operations To Mexican Manufacturing Plant 255
18.5.10 Mar 30, 2009: Zimmer
Announces Expiration Of DPA 255
18.5.11 Mar 06, 2009: SBi Increases
Donation To Limb Salvage Centers Of Devices From $500,000 To $1.2 Million
255
18.5.12 Mar 04, 2009: Wright Medical To Exhibit Foot And Ankle Product
Innovations At 2009 ACFAS Meeting 256
18.5.13 Feb 24, 2009: Medtronic To
Voluntarily Disclose Payments To US Physicians 257
18.5.14 Feb 23, 2009:
DJO To Showcase Number Of Products At AAOS Meeting In Las Vegas 258
18.5.15 Feb 23, 2009: Wright Medical To Unveil New Products For Knees, Ankles,
Hips And Wrists At AAOS 260
18.5.16 Feb 18, 2009: Integra Donates Over $1
Million In Medical Instruments To Direct Relief International 261
18.5.17
Feb 09, 2009: RTI Announces Distribution And Supply Agreement With Aesculap
For BioCleanse-Sterilized Spinal Allografts 261
18.5.18 Feb 05, 2009:
Medtronic Applauds Introduction Of The National Pain Care Policy Act To
Address Therapy Access For Patients 261
18.5.19 Feb 02, 2009: Artimplant
And SBi Revise Terms Of Five License, Supply And Distribution Agreements
262
18.5.20 Jan 12, 2009: Zynex Reports Increased Orders In December 2008
263
18.5.21 Jan 09, 2009: Integra Unveils A Series Of PEEK-Optima
Interbody Spinal Implants 263
18.5.22 Jan 05, 2009: Wright Medical CEO To
Participate In 27th Annual JP Morgan Healthcare Conference 263
18.6
Product Approvals 265
18.6.1 May 04, 2009: CoreSpine Technologies'
XTEND-ST Nucleus Removal System Receives 510(k) Clearance 265
18.6.2 May
04, 2009: X-spine' s Calix Spinal Implant System Receives FDA Clearance 265
18.6.3 Apr 27, 2009: FDA Clears ETEX Corporation' s Small Size Beta-bsm
Injectable Paste And Gamma-bsm Moldable Putty 265
18.6.4 Apr 22, 2009: US
FDA Approves MiMedx Group' s Paradis Vaso Shield Device 265
18.6.5 Apr 16,
2009: DJO Receives FDA 510(k) Clearance For Intelect SWD Shortwave Diathermy
Device 266
18.6.6 Apr 08, 2009: Core Essence Announces 510(k) Clearance
For SECURUS Suture Anchor System 266
18.6.7 Apr 02, 2009: LDR Corporation
Receives US FDA Approval For Its ROI-A ALIF Device 267
18.6.8 Feb 26,
2009: Genzyme Announces FDA Approval For Synvisc-One For Osteoarthritis Of The
Knee 267
18.6.9 Feb 10, 2009: US FDA Grants 510(k) Clearance For K2M' s
tifix CAYMAN Plate Systems 268
18.6.10 Feb 02, 2009: NIMS Receives FDA
Approval To Market Exer-Rest 268
19 Appendix 269
19.1 Global Markets
Direct Research Methodology 269
19.2 Coverage 270
19.3 Secondary
Research 270
19.4 Primary Research 271
19.5 Models 271
19.6
Forecasts 272
19.7 Expert Panel Validation 272
19.8 Currency
Conversion 273
19.9 Contact Us 274
19.10 Disclaimer 274
1.1 List of Tables
Table 1: United States Healthcare Expenditure,
2003-2010 29
Table 2: Total Number of Doctors in the United States,
2003-2010 32
Table 3: Number of Doctors by Specialty in the United States,
2003-2010 33
Table 4: United States Healthcare Trade Statistics, 2001-2006
34
Table 5: Medical Equipment Registration Fee in United States, 2007
41
Table 6: Medical Device Approval Time in United States 41
Table 7:
Orthopedic Devices, Cross Country Comparison, Revenue ($ mn), 2000-2015
46
Table 8: Orthopedic Devices, United States, Overall Revenue ($
mn), 2000-2015 47
Table 9: Orthopedic Devices, United States,
Cross-Category Analysis, 2000-2015 48
Table 10: Orthopedic Devices,
United States, Overall Revenue ($ mn), Historic, 2000-2008 49
Table 11:
Orthopedic Devices, United States, Overall Revenue ($ mn), Forecast,
2008-2015 50
Table 12: Orthopedic Devices, United States, Category
Volume (Units), 2000-2015 51
Table 13: Orthopedic Devices, United
States, Category Volume (Units), Historic, 2000-2008 53
Table 14:
Orthopedic Devices, United States, Category Volume (Units), Forecast,
2008-2015 55
Table 15: Orthopedic Devices, United States, Company
Share by Revenue ($ mn), 2007-2008 56
Table 16: Arthroscopy, United
States, Revenue ($ mn), Historic, 2000-2008 57
Table 17: Arthroscopy,
United States, Revenue ($ mn), Forecast, 2008-2015 58
Table 18:
Arthroscopy, United States, Volume (Units) by Segment, Historic, 2000-2008
59
Table 19: Arthroscopy, United States, Volume (Units) by Segment,
Forecast, 2008-2015 60
Table 20: Arthroscopy, United States, Average
Price ($), Historic, 2000-2008 61
Table 21: Arthroscopy, United
States, Average Price ($), Forecast, 2008-2015 61
Table 22:
Arthroscopy, United States, Distribution Share by Revenue ($mn), 2007-2008
61
Table 23: Arthroscopy, United States, Company Share by Revenue ($
mn), 2007-2008 62
Table 24: Joint Reconstruction, United States,
Revenue ($ mn) by Segment, Historic, 2000-2008 63
Table 25: Joint
Reconstruction, United States, Revenue ($ mn) by Segment, Forecast, 2008-2015
64
Table 26: Hip Replacement, United States, Revenue ($ mn) by
Sub-Segment, Historic, 2000-2008 65
Table 27: Hip Replacement, United
States, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 66
Table 28:
Knee Replacement, United States, Revenue ($ mn) by Sub-Segment, Historic,
2000-2008 67
Table 29: Knee Replacement, United States, Revenue ($
mn) by Sub-Segment, Forecast, 2008-2015 68
Table 30: Shoulder
Replacement, United States, Revenue ($ mn) by Sub-Segment, Historic, 2000-2008
69
Table 31: Shoulder Replacement, United States, Revenue ($ mn) by
Sub-Segment, Forecast, 2008-2015 70
Table 32: Joint Reconstruction,
United States, Volume (Units) by Segment, Historic, 2000-2008 71
Table 33:
Joint Reconstruction, United States, Volume (Units) by Segment, Forecast,
2008-2015 72
Table 34: Hip Replacement, United States, Volume (Units)
by Sub-Segment, Historic, 2000-2008 73
Table 35: Hip Replacement,
United States, Volume (Units) by Sub-Segment, Forecast, 2008-2015 74
Table
36: Knee Replacement, United States, Volume (Units) by Sub-Segment,
Historic, 2000-2008 75
Table 37: Knee Replacement, United States,
Volume (Units) by Sub-Segment, Forecast, 2008-2015 76
Table 38:
Shoulder Replacement, United States, Volume (Units) by Sub-Segment, Historic,
2000-2008 77
Table 39: Shoulder Replacement, United States, Volume
(Units) by Sub-Segment, Forecast, 2008-2015 78
Table 40: Joint
Reconstruction, United States, Average Price ($), Historic, 2000-2008 79
Table 41: Joint Reconstruction, United States, Average Price ($),
Forecast, 2008-2015 80
Table 42: Joint Reconstruction, United States,
Distribution Share by Revenue ($mn), 2007-2008 81
Table 43: Joint
Reconstruction, United States, Company Share by Revenue ($ mn), 2007-2008
82
Table 44: Orthobiologics, United States, Revenue ($ mn) by
Segment, Historic, 2000-2008 83
Table 45: Orthobiologics, United
States, Revenue ($ mn) by Segment, Forecast, 2008-2015 84
Table 46:
Bone Graft Substitutes, United States, Revenue ($ mn) by Sub-Segment,
Historic, 2000-2008 85
Table 47: Bone Graft Substitutes, United
States, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 86
Table 48:
Orthobiologics, United States, Volume (Units) by Segment, Historic,
2000-2008 87
Table 49: Orthobiologics, United States, Volume (Units)
by Segment, Forecast, 2008-2015 88
Table 50: Bone Graft Substitutes,
United States, Volume (Units) by Sub-Segment, Historic, 2000-2008 89
Table
51: Bone Graft Substitutes, United States, Volume (Units) by Sub-Segment,
Forecast, 2008-2015 90
Table 52: Orthobiologics, United States,
Average Price ($), Historic, 2000-2008 91
Table 53: Orthobiologics,
United States, Average Price ($), Forecast, 2008-2015 91
Table 54:
Orthobiologics, United States, Distribution Share by Revenue ($mn), 2007-2008
92
Table 55: Orthobiologics, United States, Company Share by Revenue
($ mn), 2007-2008 94
Table 56: Orthopedic Accessories, United States,
Revenue ($ mn) by Segment, Historic, 2000-2008 95
Table 57:
Orthopedic Accessories, United States, Revenue ($ mn) by Segment, Forecast,
2008-2015 96
Table 58: Orthopedic Accessories, United States, Volume
(Units) by Segment, Historic, 2000-2008 97
Table 59: Orthopedic
Accessories, United States, Volume (Units) by Segment, Forecast, 2008-2015
98
Table 60: Orthopedic Accessories, United States, Average Price
($), Historic, 2000-2008 99
Table 61: Orthopedic Accessories, United
States, Average Price ($), Forecast, 2008-2015 99
Table 62:
Orthopedic Accessories, United States, Distribution Share by Revenue ($mn),
2007-2008 100
Table 63: Orthopedic Accessories, United States,
Company Share by Revenue ($ mn), 2007-2008 101
Table 64: Orthopedic
Braces and Supports, United States, Revenue ($ mn) by Segment, Historic,
2000-2008 102
Table 65: Orthopedic Braces and Supports, United
States, Revenue ($ mn) by Segment, Forecast, 2008-2015 103
Table 66:
Orthopedic Braces and Supports, United States, Volume (Units) by Segment,
Historic, 2000-2008 104
Table 67: Orthopedic Braces and Supports,
United States, Volume (Units) by Segment, Forecast, 2008-2015 105
Table
68: Orthopedic Braces and Supports, United States, Average Price ($),
Historic, 2000-2008 106
Table 69: Orthopedic Braces and Supports,
United States, Average Price ($), Forecast, 2008-2015 106
Table 70:
Orthopedic Braces and Supports, United States, Distribution Share by Revenue
($mn), 2007-2008 107
Table 71: Orthopedic Braces and Supports, United
States, Company Share by Revenue ($ mn), 2007-2008 108
Table 72:
Spinal Surgery, United States, Revenue ($ mn) by Segment, Historic, 2000-2008
109
Table 73: Spinal Surgery, United States, Revenue ($ mn) by
Segment, Forecast, 2008-2015 110
Table 74: Spinal Fusion, United
States, Revenue ($ mn) by Sub-Segment, Historic, 2000-2008 111
Table 75:
Spinal Fusion, United States, Revenue ($ mn) by Sub-Segment, Forecast,
2008-2015 112
Table 76: Spinal Non-Fusion, United States, Revenue ($
mn) by Sub-Segment, Historic, 2000-2008 113
Table 77: Spinal
Non-Fusion, United States, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015
114
Table 78: Spinal Surgery, United States, Volume (Units) by
Segment, Historic, 2000-2008 115
Table 79: Spinal Surgery, United
States, Volume (Units) by Segment, Forecast, 2008-2015 116
Table 80:
Spinal Fusion, United States, Volume (Units) by Sub-Segment, Historic,
2000-2008 117
Table 81: Spinal Fusion, United States, Volume (Units)
by Sub-Segment, Forecast, 2008-2015 118
Table 82: Spinal Non-Fusion,
United States, Volume (Units) by Sub-Segment, Historic, 2000-2008 119
Table 83: Spinal Non-Fusion, United States, Volume (Units) by
Sub-Segment, Forecast, 2008-2015 120
Table 84: Spinal Surgery, United
States, Average Price ($), Historic, 2000-2008 121
Table 85: Spinal
Surgery, United States, Average Price ($), Forecast, 2008-2015 121
Table
86: Spinal Surgery, United States, Distribution Share by Revenue ($mn),
2007-2008 122
Table 87: Spinal Surgery, United States, Company Share
by Revenue ($ mn), 2007-2008 123
Table 88: Trauma Fixation, United
States, Revenue ($ mn) by Segment, Historic, 2000-2008 124
Table 89:
Trauma Fixation, United States, Revenue ($ mn) by Segment, Forecast, 2008-2015
125
Table 90: Internal Fixators, United States, Revenue ($ mn) by
Sub-Segment, Historic, 2000-2008 126
Table 91: Internal Fixators,
United States, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 127
Table 92: Trauma Fixation, United States, Volume (Units) by Segment,
Historic, 2000-2008 128
Table 93: Trauma Fixation, United States,
Volume (Units) by Segment, Forecast, 2008-2015 128
Table 94: Internal
Fixators, United States, Volume (Units) by Sub-Segment, Historic, 2000-2008
129
Table 95: Internal Fixators, United States, Volume (Units) by
Sub-Segment, Forecast, 2008-2015 130
Table 96: Trauma Fixation,
United States, Average Price ($), Historic, 2000-2008 131
Table 97:
Trauma Fixation, United States, Average Price ($), Forecast, 2008-2015 131
Table 98: Trauma Fixation, United States, Distribution Share by Revenue
($mn), 2007-2008 132
Table 99: Trauma Fixation, United States,
Company Share by Revenue ($ mn), 2007-2008 133
Table 100: DePuy, Inc.
Pipeline Products by Equipment Type 134
Table 101: DePuy, Inc.
Pipeline Products by Development Stage 135
Table 102: DePuy, Inc.
Pipeline Products by Therapy Area 135
Table 103: DePuy, Inc. Pipeline
Products by Clinical Trials 136
Table 104: DePuy, Inc. Pipeline
Products by News Summaries 136
Table 105: Stryker Corporation
Pipeline Products by Equipment Type 139
Table 106: Stryker
Corporation Pipeline Products by Development Stage 139
Table 107:
Stryker Corporation Pipeline Products by Therapy Area 140
Table 108:
Stryker Corporation Pipeline Products by Clinical Trials 140
Table 109:
Zimmer Holdings, Inc. Pipeline Products by Equipment Type 144
Table 110:
Zimmer Holdings, Inc. Pipeline Products by Development Stage 144
Table 111: Zimmer Holdings, Inc. Pipeline Products by Therapy Area
144
Table 112: Zimmer Holdings, Inc. Pipeline Products by Clinical
Trials 145
Table 113: Medtronic, Inc. Pipeline Products by Equipment
Type 148
Table 114: Medtronic, Inc. Pipeli
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