Global Orthopedic Instrumentation Industry

Keywords : Orthopedic, hip implant, knee implant, Orthopedic instrument, spinal implant, hip replacement, Orthopaedic, Orthopedic implant, Orthopedic device, reconstruction implant, orthopedics, total hip replacement, Orthopaedic instrument, Suture Anchor, Internal Fixator, Pedicle screw, total knee replacement prosthesis

This report analyzes the worldwide markets for Orthopedic Instrumentation in US$ Million by the following Product Segments: Reconstructive Sector (Hip Implants, Knee Implants, & Extremities), Fracture Fixation, Arthroscopy, Spinal Implants, and Other Products. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World. Annual estimates and forecasts are provided for the p...

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This report analyzes the worldwide markets for Orthopedic Instrumentation in US$ Million by the following Product Segments: Reconstructive Sector (Hip Implants, Knee Implants, & Extremities), Fracture Fixation, Arthroscopy, Spinal Implants, and Other Products. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World. Annual estimates and forecasts are provided for the period 2009 through 2017. Also, a six-year historic analysis is provided for these markets. The report profiles 199 companies including many key and niche players such as AAP Implantate AG/aap mebio, Acumed LLC, Arthrex, Inc., B. Braun Melsungen AG, Biomet, Inc., Conmed Corp., DJO Surgical, Exactech, Inc., Innomed, Inc., Japan Medical Dynamic Marketing (MDM), Inc., Johnson & Johnson, DePuy, Inc., Medtronic Sofamor Danek, Inc., Orthofix International N.V., Smith and Nephew Plc, Smith & Nephew, Inc., Stryker Corporation, Stryker Orthopaedics, Synthes Holding AG, Wright Medical Technology, Inc., and Zimmer Holdings, Inc. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based upon search engine sources in the public domain.

Global Orthopedic Industry

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation & Reporting Level I-3
Quantitative Techniques & Analytics I-3
Product Definitions and Scope of Study I-3
Reconstructive Sector I-4
Hip Implants I-4
Knee Implants I-4
Extremities I-4
Fracture Fixation I-4
Arthroscopy I-5
Spinal Products I-5
Other Products I-5


II. EXECUTIVE SUMMARY

1. INDUSTRY OVERVIEW II-1
Orthopedic Industry: Countering the Challenges of Recession II-1
Emerging Technologies to Redefine the Future II-1
Factors Influencing Industry Dynamics II-2
Growth Drivers, Trends & Issues II-3
Aging Population Drives Demand II-3
Prevalence of Osteoporosis, Arthritis and other Joint
Diseases Fuel Market Growth II-3
Increasing Cases of Musculoskeletal Problems II-4
Table 1: Select Musculoskeletal Conditions - Percentage
Breakdown by Age Group (includes corresponding Graph/Chart) II-5
Increasing Life Expectancy Rates II-5
Developing Markets - High Potential II-5
Cost Containment Issues II-6
Revision Procedures Buoy Growth II-6
Minimally Invasive Surgery Attracts Attention II-6
Advanced Materials & Technologies Foster Growth II-7
Advanced Coatings - Enhancing Lifespan of Implants II-8
Demand for Premium Implants Continues II-8
Growing Demand for Total Hip Replacement in Young People II-8
Hip Resurfacing Replacement for Younger Generation II-9
Table 2: Leading Manufacturers in the Global Hip Resurfacing
Market (2008 & 2009): Percentage Share Breakdown of Value
Sales for Smith and Nephew, Stryker, Wright Medical and
DePuy (Johnson and Johnson) (includes corresponding
Graph/Chart) II-9
Gender-Specific Orthopedic Devices Gain Momentum II-10
Spinal and Orthobiologics Products Spearhead Growth II-10
Synthetic Substitutes, Growth Factors and Composites II-10
Stem Cell and Gene Therapy II-11
Growing Presence of Mid-Tier Firms & Start-Ups in Spinal Segment II-11
Rising Production Costs & Complexities in Documentation -
Major Challenges II-11

2. ORTHOPEDICS MARKET STRUCTURE II-12
Anatomy of the Industry II-12
Designing of Device: Complex Requirements II-12
Futuristic View of Designs II-13

3. REVIEW OF PRODUCT SEGMENTS II-14
Reconstructive Market II-14
Highlights II-14
Table 3: Hip Implant Procedures in US and Europe (2010):
Percentage Breakdown by Number of Procedures for Primary
Hip, Revision Hip and Endoprosthesis (includes corresponding
Graph/Chart) II-15
Countering Rising Hip Implant Prices II-15
Tooth ‘N Trouble II-16
Future of Reconstructive Sector II-16
Hip and Knee Implants Market II-16
Technological Advancements Encourage Young Patients to Opt
for Surgeries II-17
Direct-to-Consumer Marketing Efforts Enhance Awareness II-17
Extremities Market II-18
Select Extremity Products of Leading Players II-18
Trauma Market II-18
Select Trauma Products of Leading Players II-19
Arthroscopy Market II-19
Spine Implants & Biologics Market II-20
Orthobiologics Market II-20
Fracture Repair Market II-21
Table 4: Fractures by Age Group (2010): Percentage Share
Breakdown of Number of Fractures by Patient Age (includes
corresponding Graph/Chart) II-21

Table 5: Global Fracture Repair Market by Segment (2010):
Percentage Share Breakdown of Value Sales for Internal
Fixation, External Fixation, and Craniomaxillofacial
(includes corresponding Graph/Chart) II-21

Table 6: Leading Players in the World Fracture Repair Market
(2010): Percentage Share Breakdown of Value Sales for
Synthes, Stryker, Smith & Nephew, Zimmer, DePuy, Biomet,
Acumed, Orthofix and Others (includes corresponding
Graph/Chart) II-22
Fracture Fixation Devices Market II-22

4. PRODUCT OVERVIEW II-23
A. Reconstructive Sector II-23
Procedure of Joint Replacement: Past and Present II-23
Insertion of Implants II-24
Revision Surgery: A Painful Procedure II-24
Cost of Implants - Determining Factors II-25
Hip Prosthesis II-25
Total Hip Replacement II-25
Conditions Requiring Total Hip Replacement II-25
Materials Used II-26
Cemented Hip Implants II-26
Cementless Hip Implants II-26
Complications Following THR II-26
Partial Hip Replacement II-26
Revision Hip Procedures II-26
Types of Hip Implants II-27
Ceramic-on-Ceramic II-27
Metal-on-Metal II-27
Highly Cross-Linked Polyethylene II-28
Ceramic-on-polyethylene II-28
Metal-on-polyethylene II-28
Knee Prosthesis II-28
Functional Aspects of the Knee II-28
Implant Design II-29
Unicondylar Knee Replacements II-29
Fixed and Mobile Bearing Knees II-30
Mobile Bearing Total Knee Replacement Prosthesis II-30
Secondary Joint Prosthesis/Extremeties II-30
Shoulder Prosthesis II-30
Ankle Prosthesis II-30
Elbow Prosthesis II-31
Finger Prosthesis II-31
B. Fracture Fixation II-31
Osteoporosis - A Bone Breaking Factor II-31
Fracture Fixation Procedures II-31
Internal Fixation II-32
External Fixation II-32
Intramedulary Fixation II-32
Maxillofacial Fixation Products II-33
Bone Growth Stimulators II-33
Select Techniques Used in Fracture Fixation II-33
Bone Graft System II-33
Osteo-Clage Cerclage Cable System II-33
Polarus Humeral Fixation System II-33
Stableloc External Fixator II-33
Nature of a Fracture II-34
Trends and Developments in the Fracture Fixation Market II-34
Novel Technologies Boost External Fixation Device Market II-34
Increase in Less Invasive Fracture Repair Procedures II-34
New Technologies Rekindle Market for Trauma Products II-35
Intramedullary Nails Threatened by LCP Systems II-35
Locking Compression Plates Might Lose its Superfluous Growth II-35
C. Arthroscopy II-36
Arthroscopy: A Keyhole Surgery II-36
A Broad Perspective II-36
Arthroscopic Procedure II-37
Arthroscopy and its Complications II-37
Knee Arthroscopy II-38
Hip Arthroscopy II-38
Shoulder Arthroscopy II-39
Arthroscopically Assisted Anterior Approach II-39
Arthroscopy of the Elbow II-39
Ankle Arthroscopy II-39
Future Developments II-39
Multi-Electrode Procedure II-39
Electrothermal Arthroscopy II-40
D. Spinal Implants and Instrumentation II-40
Spinal Fusion - Lending Support to the Troubled Backs II-40
Spinal Implants Market in the Past: A Historic Perspective II-41
Table 7: Spinal Implant Market Worldwide (2004) -
Percentage Breakdown by Number of Surgeries for
Degenerative Lumbar, Cervical, Deformities, Thoraco-Lumbar
Traumas and Thoraco-Lumbar Tumors (includes corresponding
Graph/Chart) II-41

Table 8: Spinal Products Market Worldwide (2004) -
Percentage Breakdown by Implant Type for Pedicel Screws,
Plates, Rods; Fusion Cages, and Others (includes
corresponding Graph/Chart) II-42
State of Spinal Fusion Cages II-42
Emerging Technologies and Techniques II-42
Non- Invasive Surgeries II-42
Universal Multilevel Fusions II-43
Motion-Sparing Technology- Leap Forward in Spinal Fusions II-43
Artificial Nuclei II-43
Lumbar Artificial Discs Launch Timeline (2000-2005) II-43
Cervical Artificial Disc Launch Timeline (2007) II-44
Artificial Disc Competitive Landscape (2004-2007) II-44
E. Other Products II-44
Bone Cement II-44
Mechanical Properties of Bone Cements II-45
Soft Goods Sector II-45

5. ASSOCIATED AND EMERGING TECHNOLOGIES IN ORTHOPEDICS II-46
Resorbables II-46
Bone Substitutes II-46
Osteoinductive Agents/Bone Graft Factors: II-47
Viscoelastics II-48
Soft Tissue Repair and Replacement II-49
Tissue Engineering II-50

6. COMPETITIVE FOCUS II-51
Competitive Factors Influencing Orthopedics Market II-51
Positive Factors II-51
Pricing and Cost Effectiveness of Products II-51
Consumer Relationships II-51
Safety and Competency of Products II-51
Technological Advancements II-51
Product Innovation II-52
Risk Factors II-52
Delays in Product Development II-52
Time Taken for Regulatory Approvals II-52
Consolidation - Resetting Competition II-53
Mergers and Acquisitions in the Worldwide Orthopedics
Industry: 2006-2010 II-53
M&A Activity: 2007-2010 in Orthopedic Instrumentation Segment II-55
Reconstructive Sector: Hip Implants, Knee Implants, Extremities II-55
Spinal Products II-55
Arthroscopy (2000-2010) II-56
Competitive Analysis II-56
Product Matrix of Leading Players in Orthopedics Industry II-56
Table 9: Leading Players in the Global Orthopedics Market
(2010): Percentage Share Breakdown of Value Sales for
Stryker, J&J, Zimmer, Medtronic, Synthes, Smith & Nephew,
Biomet, and Others (includes corresponding Graph/Chart) II-57
Reconstructive Sector II-57
Leading Players in Select Orthopedic Implant Markets II-57
Table 10: Leading Players in the Global Reconstructive/
Orthopedic Implant Market (2010): Percentage Share Breakdown
of Value Sales for Zimmer, J&J, Stryker, Biomet, Smith &
Nephew, and Others (includes corresponding Graph/Chart) II-58

Table 11: Leading Manufacturers in the Global Hip Implant
(Reconstructive) Market (2011): Percentage Share Breakdown
of Unit Sales for Zimmer, DePuy, Stryker, Biomet and Others
(includes corresponding Graph/Chart) II-58

Table 12: Leading Manufacturers in the Global Knee Implant
(Reconstructive) Market (2009): Percentage Share Breakdown
of Value Sales for Zimmer, DePuy, Stryker, Biomet, Smith &
Nephew, Wright Medical, Exactech and Others (includes
corresponding Graph/Chart) II-59

Table 13: Leading Manufacturers in the Global Spinal Implant
(Reconstructive) Market (2009): Percentage Share Breakdown
of Value Sales for Zimmer, Stryker, JNJ DePuy, Biomet, Smith
& Nephew, Wright Medical, Exactech and Others (includes
corresponding Graph/Chart) II-59

Table 14: Leading Manufacturers in the Global Hip and Knee
Implants Market (2009): Percentage Share Breakdown of Value
Sales for Zimmer, DePuy, Stryker, Biomet, Smith & Nephew,
and Others (includes corresponding Graph/Chart) II-60
Hip Implants II-61
Table 15: Leading Players in Worldwide Hip Implants Market
(2008 & 2012): Percentage Breakdown of Dollar Sales by
Company for Zimmer, J&J DePuy, Stryker, Smith & Nephew,
Biomet, Wright Medical and Others (includes corresponding
Graph/Chart) II-61
Knee Implants II-62
Table 16: Leading Players in Worldwide Knee Implants Market
(2008 & 2012): Percentage Breakdown of Dollar Sales by
Company for Zimmer, J&J DePuy, Stryker, Biomet, Smith &
Nephew, Wright Medical and Others (includes corresponding
Graph/Chart) II-62
Extremities II-63
Table 17: Leading Players in the Global Extremities Market
(2009 & 2012): Percentage Share Breakdown of Value Sales for
DePuy, Tornier, Zimmer, Wright Medical, Biomet, and Others
(includes corresponding Graph/Chart) II-63
Fracture Fixation II-64
Table 18: Global Fracture Repair Market (2009): Percentage
Share Breakdown of Value Sales for Synthes, Stryker, Smith &
Nephew, Zimmer, DePuy, Biomet, Acumed, Orthofix, and Others
(includes corresponding Graph/Chart) II-64
Internal Fixation II-64
External Fixation II-64
Table 19: Leading Players in the Global Trauma &
Craniomaxillofacial Market (2009): Percentage Share
Breakdown of Value Sales for Synthes, Stryker, Smith &
Nephew, J&J, Zimmer, Biomet, and Others (includes
corresponding Graph/Chart) II-65

Table 20: Leading Players in the Global Trauma Market
(2008): Percentage Share Breakdown of Value Sales for
Synthes, Stryker, Smith & Nephew, Zimmer, DePuy, and Others
(includes corresponding Graph/Chart) II-65

Table 21: Leading Players in the Global CMF Market (2008):
Percentage Share Breakdown of Value Sales for Synthes,
Stryker, Biomet, KLS Martin, OsteoMed, Medartis, and Others
(includes corresponding Graph/Chart) II-65
Arthroscopy II-66
Table 22: Leading Players in the Global Arthroscopy Market
(2009): Percentage Share Breakdown of Value Sales for Smith &
Nephew, Arthrex, Mitek/J&J, Stryker, Arthrocare, ConMed
Linvatec, and Others (includes corresponding Graph/Chart) II-66
Spinal Products II-66
Table 23: Leading Players in the Global Spine Market (2009):
Percentage Share Breakdown of Value Sales for Medtronic,
DePuy, Synthes, Stryker, NuVasive, Zimmer, Orthofix, Globus,
Biomet, and Others (includes corresponding Graph/Chart) II-67

Table 24: Global Spinal Implants Market (2009): Percentage
Share Breakdown of Value Sales for Medtronic, J&J, Synthes,
Stryker, NuVasive, Globus, Zimmer, and Others (includes
corresponding Graph/Chart) II-67

Table 25: Leading Players in the Global Orthobiologics Market
(2009): Percentage Share Breakdown of Value Sales for
Medtronic, Synthes, J&J, Osteotech, Smith & Nephew, Stryker,
and Others (includes corresponding Graph/Chart) II-68

7. END USERS OF ORTHOPEDIC INSTRUMENTS II-69
Competitive Factors from End-Use Perspective II-69
Demographics Crucial Factor Driving Demand II-69
Hospitals: The Largest End-Use Industry II-69
Physicians’ Offices/Clinics II-70
New Technology Adds to the Growth II-70
Home Health Care Market: A Fast Growing Segment II-70

8. DISTRIBUTION STRUCTURE - A SKELETAL VIEW II-71
An Insight into the Distribution Network of Select Players II-71
BioMet, Inc. II-71
Medtronic Sofamor Danek II-71
Synthes II-72
Zimmer Holdings, Inc. II-72

9. TECHNOLOGICAL DEVELOPMENTS II-73
Alternate-Bearing Materials in the Hip Implants Market II-73
Diamond-on-Diamond Technology II-73
Cementless Procedures Gain Ground II-73
Trabecular Metal Technology II-74
Surface Modification Technology II-74
Novel Minimally Invasive Approaches II-74
Zimmer Launches Quad-Sparing Total Knee Replacement II-74
Spire’s Subsidiary Expands Ion Implantation Processing II-75
Zimmer to Launch New Minimally Invasive Hip Procedure II-75
DePuy Introduces New Mini-Incision Technique in Hip Replacement II-75

10. PRODUCT INNOVATIONS/INTRODUCTIONS II-76
Medtronic Unveils KYPHON® Express™ for Vertebral Compression
Fracture Treatment II-76
X-spine Receives FDA Clearance for Fixcet ™ Spinal Facet Screw
System II-76
Alphatec Spine Introduces Four Novel Products in Biologics,
Thoracolumbar and MIS Market II-76
Orthofix International Unveils Spinal Deformity Correction Module II-77
SI-BONE to Unveil iFuse Implant System™ II-77
Maxx Medical Unveils Freedom Total Knee® System II-77
DePuy Mitek Rolls Out VERSALOK PEEK Rotator Cuff Anchor II-77
SANUWAVE Health Launches OrthoPACE™ Device in Europe II-78
Medtronic Introduces Kyphon ActivOs 10 Bone Cement with
Hydroxyapatite II-78
Ascension Orthopedics Rolls Out Ascension NuGrip CMC Implant II-78
Aesculap Implant Systems Unveils S4 Element™ Pedicle Screw System II-79
DePuy Spine Introduces EXPEDIUM® VBD Instrument II-79
Stryker Unveils iVAS™ Inflatable Vertebral Augmentation System II-79
CareFusion Introduces AVAmax® Vertebral Balloon II-80
Integra LifeSciences Introduces Integra Spine's Paramount PS
Fixation System II-80
Ascension Orthopedics Unveils PyroTITAN™ Humeral Resurfacing
Arthroplasty System II-81
DiFusion Technologies Receives FDA Approval for Xiphos
Posterior Interbody Devices II-81
Titan Spine Unveils Endoskeleton® TC System II-81
Interventional Spine Completes Implant of RENEW™ Interspinous
Allograft Technology II-81
Exactech Secures Approval to Market Novation® Hip System in Japan II-82
Stryker Orthopaedics Unveils ADM Mobile Bearing Acetabular and
Rejuvenate Modular Primary Hip Systems II-82
Wright Medical Launches ORTHOLOC Polyaxial Locked Plating System II-82
BioMimetic’s Augment Bone Graft Receives Approval from Health
Canada II-83
MiMedx Group Rolls Out Paradis Vaso Shield™ II-83
Medtronic Launches SOVEREIGN™ Spinal System II-83
Signus Medical Launches DIALOG Sacroiliac Joint Fusion System II-83
MAKO Surgical Introduces Lateral Unicompartmental Knee
Surfacing Application II-84
CONMED Unveils Bullseye Anatomic Cruciate Reconstruction System II-84
CONMED Linvatec Introduces Small Biocomposite Interference Screw II-84
Medtronic Rolls Out TSRH® 3Dx™ Spinal System II-84
Medtronic Rolls Out Mastergraft Strip II-85
Custom Spine Introduces Two New Spine Systems II-85
K2M Introduces TERRA NOVA® and SERENGETI® II-85
Covidien Unveils DuraSeal™ Spine Sealant II-85
DePuy Spine Expands Spinal Pathology Solutions Portfolio II-85
US Spine Introduces MIS Locking Facet System II-85
US Spine Introduces Facet Gun MAX II-86
U.S. Spinal Technologies Introduced Phantom Plus™ Interbody
Fusion System II-86
Smith & Nephew Rolls Out TRUCATH Spinal Injection System II-86
US Spine Launches Preference 2 Complex Spine System™ II-86
CONMED Introduces Linvatec Shoulder Restoration System II-87
Smith & Nephew's Endoscopy Division Introduces BICEPTOR™
Tenodesis System II-87
Integra LifeSciences Introduces Coral™ Extended Tab Spinal
Screw Series II-88
Medtronic Introduces Novel Orthopedic Devices II-88
DePuy Spine Introduces HEALOS® Fx Injectable Bone Graft
Replacement II-88
Orteq Inks Agreement with FH Orthopaedics to Launch Actifit
Meniscal Implant II-89
Smith & Nephew Introduces VISIONAIRE Patient Matched
Instrumentation II-89
Ascension Orthopedics Unveils Ascension® Silicone PIP System II-89
SpineSource® Introduces SHELL™ Cervical PEEK Optima® Cage II-90
Integra LifeSciences Holdings Introduces Vu L•POD™ and Vu e•
POD™ IBD II-90
Ouroboros Medical Obtains Clearance to Market Spinal Fusion
Product II-90
Bonovo Orthopedics to Market Pioneer’s Spinal Fusion Products II-91
HydroCision Introduces SpineJet® Percutaneous Curved Access Set II-91
Tornier Implements Human Implant of Shoulder Arthroplasty
Prosthesis II-91
X-spine Systems Obtains FDA Approval for Calix Spinal Implant
System II-91
Bonesupport Receives EU Clearance for Cerament Bone Void Filler II-92
DiFUSION Technologies Completes Testing of Silver Ion-based
Antimicrobial Technology II-92
Wright Medical Introduces Titanium Knee Implant II-93
Medtronic Introduces NANOSTIM® Synthetic Bone Paste II-93
CONMED Unveils Medical Devices II-93
DePuy Unveils Pinnacle Hip Solutions II-94
Smith & Nephew Introduces VERILAST™ Technology II-94
DePuy Expands Sigma® Knee Product Portfolio II-94
Smith & Nephew Introduces R3™ Acetabular Cup System for Hip
Replacement II-95
Smith & Nephew Launches Bioraptor 2.3 PK Suture Anchor II-95
RTI Introduces of Fresh-Stored OC Allografts II-95
Wright Medical Group Launches Profemur Xm Hip Stem II-95
ConforMIS Launches Patient-Specific Implant II-95
Stryker Introduces Triathlon PKR System in the US II-96
Orthovita Launches New Bone Graft Substitute II-96
DePuy Launches ALPS for Orthopaedic Trauma II-96
DJO Surgical Gains FDA Approval to Market New X-alt II-96
Osteotech Obtains FDA Clearance for Plexur M Biocomposite II-97
ConforMIS Wins CE Mark Approvals for Two Arthritis Products II-97

11. PRODUCT INNOVATIONS/INTRODUCTIONS IN THE RECENT PAST - A
PERSPECTIVE BUILDER II-98
Smith & Nephew Unveils New High Definition Surgical Camera System II-98
Modern Plastics Announces New Medical Grade PMMA II-98
Wright Medical Introduces a New Biologic Grafting System II-98
Wright Medical Unveils Hip Solutions Products II-98
Smith & Nephew Introduces Bi-Compartmental Knee System II-99
DePuy Introduces Computer Software for Assisting Surgery II-99
Medtronic Launches CD Horizon® Legacy™ Anterior Spinal System II-99
Depuy Orthopaedics Unveils New Coating for Biological Fixation II-99
DePuy Introduces Delta Xtend™ Reverse Shoulder System II-99
DePuy Launches New System for Hip Fractures II-100
DePuy Introduces New Hip-Bearing System II-100
DePuy Introduces Pinnacle® Acetabular Cup System AltrX™ II-100
Biomet Introduces Two New Hip Stem Products II-100
ArthroCare Introduces Opus® TwinLock™ Knotless Fixation System II-101
SBI Introduces Advanced RingFIX™ System and Forefoot Repair Set II-101
SBI Launches New Distal Radius Plating System II-101
Smith & Nephew Endoscopy Introduces New Lateral Hip Distractor II-102
HydroCision Launches SpineJet® EndoResector II-102
Wright Medical Launches Latest Stature-Specific Knee Replacement II-102
Integra LifeSciences Introduces Uni-CP Compression Plate II-102
Wright Medical Introduces the CAROLINA™ Jones Fracture II-103
Wright Medical Launches EVOLVE® PROLINE System II-103
SBi Launches Artelon® STT Spacer II-103
Amedica Gains FDA Approval for Valeo VBR Spinal Implant II-103
Amedica Obtains FDA Marketing Approval for Valeo Pedicle Screw
System II-104
Corin Group Obtains FDA for Cormet Resurfacing Hip Device II-104
Altiva Obtains FDA Approval for Altiva® Classic ACP II-104
SBI Obtains FDA Approval for Artelon CMC Spacer Arthro II-104
Smith & Nephew’s Knee Systems Receive FDA Approval II-104
Amedica Gains FDA Clearance for Valeo™ Cervical Plate System II-105
Zimmer Obtains FDA Approval for Zimmer® NexGen® Knee II-105
Invibio Receives Approval to Market Implantable Spinal Implant
in Japan II-105
BioMedical Obtains FDA Clearance for OSSpine Spinal Product II-105
Blackstone Medical Introduces New Spinal Fusion Product line II-106
CONMED Linvatec Launches New Powered Surgical Instruments &
Arthroscopy Products II-106
Smith & Nephew Introduces New JOURNEY BI-Cruciate Stabilized
Knee System II-107
Stryker Launches Triathlon Knee System for Women II-107
Wright Medical Unveils ODYSSEY™ Distal Cut First Instruments
for MIS Procedures II-107
FDA Grants Approval for Marketing Smith & Nephew’s BHR System II-108

12. RECENT INDUSTRY ACTIVITY II-109
Johnson & Johnson to Acquire Synthes II-109
Amedica Takes Over US Spine II-109
Medtronic to Take Over Osteotech II-110
NeuroTherm Takes Over Smith & Nephew's Interventional Spine
Pain Management Business II-110
Stryker Acquires Ascent Healthcare Solutions II-110
Alphatec Spine Acquires Scient’x Groupe II-111
Arthrex Acquires iBalance Medical II-111
Zimmer to Acquire Beijing Montagne II-111
Olympus Acquires Minor Stake in Small Bone Innovations II-112
Crocker Ventures Takes Over TMJ Implants II-112
Welsh Carson Acquires Stake in K2M II-112
Orthopaedic Synergy Acquires PRAXIM II-112
Memometal Technologies Acquires OrthoGlide® Ankle Technology II-113
Riverside Acquires Eska Implants II-113
Exactech Takes Over VertiFlex's Minimally Invasive Spine
Technologies and Products II-113
Exactech Takes Over Brighton Partners II-114
Landec Takes Over Lifecore Biomedical II-114
Seneca Acquires Majority Share in Micro Machine II-114
X-spine Systems Signs License Agreement with Gamma Spine II-115
Hasco Medical and Bell-Horn Sign Agreement II-115
DePuy Takes Over Finsbury II-115
Wenzel Spine Acquires DJO Surgical’s Spine Product Lines II-116
Stryker Takes Over OtisMed II-116
Biomet Acquires Assets of Cartilix II-116
Circle Medical Devices Merges with Texcel Medical II-116
Facet Solutions Purchases Archus Orthopedics' Assets II-117
Cardo Medical Takes Over Assets and Intellectual Property from
Vertebron II-117
Orthofix and MBA Group Enter into Agreement II-117
Hanger Orthopedic Acquires Custom Orthopedics and Creative
Orthotics & Prosthetics II-118
Integra LifeSciences Acquires IST II-118
Carlyle Group Snaps Up Groupe Marle II-118
SBi Snaps Up Link America II-118
K2M Partners with Smith & Nephew II-119
AdvanSource Signs Agreement with Orthopedic Device Manufacturer II-119
Wright Medical Takes Over INBONE Technologies II-119
Riverside Acquires Summit Medical II-120
UniPhar to Acquire Forth Medical and Northstar II-120
Regeneration Technologies and Tutogen Merge to Form RTI Biologics II-120
Precimed Acquires DePuy Orthopaedics' Chaumont Plant II-120
SBI to Acquire Ankle Replacement Technology II-121
Symmetry Medical Acquires Orthopaedic Instrument Facility of
DePuy II-121
Greatbatch Completes Acquisition of Precimed II-121
Exactech Acquires Altiva II-122
Exactech to Acquire France Medica; Starts Direct Distribution
in Japan II-122
Tornier and LifeCell Sign Distribution Agreement II-122
Osteotech Enters into Distribution Agreement with Harvest
Technologies II-122
Misonix Signs Distribution Deal with Aesculap II-123
Alynx Acquires MiMedx II-123
Alphatec Acquires Rights for Interbody/Vertebral Body
Replacement Technology II-123
Exactech Inks License Deal for Cartilage Repair Technology II-124
Biomet Ties Up with Massachusetts General Hospital for
Clinical Studies II-124
Stryker Recalls Select Hip Products II-124
Norman Noble Increases Orthopedic Implant Production Operations II-124

13. CORPORATE ACTIVITY IN THE RECENT PAST - A PERSPECTIVE BUILDER II-125
Biomet Merges with LVB Acquisition Merger Sub II-125
Cardinal Health Completes Acquisition of VIASYS Healthcare II-125
Biomet Sports Medicine and Marc Tec Ink Licensing Agreement II-125
Zimmer Inks a Distribution Agreement with Regeneration
Technologies II-126
Sandvik Inks Agreement with Medtronic to Acquire Medtronic’s
Plant II-126
Medtronic and Weigao to Establish Joint Venture in China II-126
HealthpointCapital Takes over Ideal Medical Products II-127
Covidien’s Subsidiary Takes Over Scandius Biomedical II-127
Integra LifeSciences Takes over IsoTis II-127
DePuy Spine Completes Acquisition of Certain Disc-O-Tech Assets II-128
Wright Medical Acquires BIO-ARCH™ Subtalar Implant II-128
UniPhar Merges Whelehan Surgical and Surgicare Divisions II-128
Orthofix International Completes Acquisition of InSWing™
Technology II-128
Sandvik Acquires Doncasters Medical Technologies II-129
Medtronic Completes Acquisition of Kyphon II-129
Tornier Takes Over DVO Extremity Solutions & Nexa Orthopedics II-129
Medtronic Takes over O-arm Imaging from Breakaway Imaging II-130
Wright Medical Takes over Assets of R&R Medical II-130
Wright Medical Acquires DARCO’s Reconstructive Foot Surgery
Business II-130
Zimmer Holdings Acquires Endius II-131
Leis Medical and MedicineLodge Merge to Form iMDs II-131
Zimmer Takes Over ORTHOsoft II-131
NuVasive Takes Over Radius Medical II-131
DJO Completes ReAble Merger II-132
Smith & Nephew Acquires Plus Orthopedics II-132
Orchid Takes Over Three Orthopedic Instrument Companies II-132
Synthes Takes Over N Spine II-133
Avalign Technologies Acquires Nemcomed II-133
Wright Medical and A.M. Surgical in Distribution and License
Agreement II-133
Symmetry Medical and MAKO Surgical Enter into an Agreement II-134
Medtronic and Axon Enter into Agreement II-134
Wright Medical Shuts Down Facility in France II-134
Portland Orthopaedics Retakes US Distribution II-134
Tornier and Bioretec in Partnership for Bioresorbable Surgical
Devices II-135
Impulse Takes Over Clinical Support Services II-135
Alphatec Holdings Gains License for Vertebroplasty Technology
System II-135
Smith & Nephew Signs Global Distribution Agreement with Teknimed II-135
Corin Enters into Marketing and Distribution Deal with Stryker II-136
Biomet and Kensey Signs Marketing and Distribution Agreement II-136
BSN Medical Acquires FLA Orthopedics II-136
SimplexityMD Takes Over OrthoAccel Technologies II-136
Hanger Orthopedic Group Acquires Paris O&P Laboratory II-136
Smith & Nephew Recalls Knee Implants II-136
Alphatec to Merge with Scient’X II-137
Endius and Quantum Form Strategic Alliance II-137
Biomet to Expand Indiana Facility II-137
DJ Orthopedics Acquires Newmed II-138
FDA Clears Zimmer’s Gender Solutions Artificial Knee for Women II-138
Zimmer Acquires Surgical Instrument Technology from MedTech S.A II-138
dj Orthopedics Acquires Aircast II-138
FDA Approves Biomet’s Regenerex™ Acetabular System II-138
DePuy Mitek Takes Over FMS Operations II-139
Medtronic Provides Research Grant to OTA II-139
Orthofix Restructures its International Business Operations II-139
Orthofix Acquires IMeS to Expand European Operations II-139

14. FOCUS ON SELECT GLOBAL PLAYERS II-140
AAP Implantate AG/aap mebio (Germany) II-140
Acumed LLC (US) II-140
Arthrex, Inc. (US) II-140
B. Braun Melsungen AG (Germany) II-141
Biomet, Inc. (US) II-141
Conmed Corp. (US) II-142
DJO Surgical (US) II-143
Exactech, Inc. (US) II-143
Innomed, Inc. (US) II-144
Japan Medical Dynamic Marketing (MDM), Inc. (Japan) II-144
Johnson & Johnson (US) II-144
DePuy Inc. (US) II-145
Medtronic Sofamor Danek, Inc. (US) II-145
Orthofix International N.V. (The Netherlands) II-146
Smith and Nephew Plc (UK) II-146
Smith & Nephew, Inc. (US) II-147
Stryker Corporation (US) II-147
Stryker Orthopaedics (US) II-147
Synthes Holding AG (Switzerland) II-148
Wright Medical Technology, Inc. (US) II-148
Zimmer Holdings, Inc. (US) II-149

15. GLOBAL MARKET PERSPECTIVE II-150
Table 26: World Recent Past, Current & Future Analysis for
Orthopedic Instrumentation by Geographic Region - US, Canada,
Japan, Europe, Asia-Pacific (excluding Japan), Latin America &
Rest of World Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2009 through 2017 (includes
corresponding Graph/Chart) II-150

Table 27: World Historic Review for Orthopedic Instrumentation
by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific
(excluding Japan), Latin America & Rest of World Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2003 through 2008 (includes corresponding
Graph/Chart) II-151

Table 28: World 15-Year Perspective for Orthopedic
Instrumentation by Geographic Region - Percentage Breakdown of
Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific
(excluding Japan), Latin America and Rest of World Markets for
Years 2003, 2011 & 2017 (includes corresponding Graph/Chart) II-152
By Segment II-153
Table 29: World Recent Past, Current & Future Analysis for
Reconstructive Sector by Geographic Region - US, Canada,
Japan, Europe, Asia-Pacific (excluding Japan), Latin America
and Rest of World Markets Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2009 through 2017
(includes corresponding Graph/Chart) II-153

Table 30: World Historic Review for Reconstructive Sector by
Geographic Region - US, Canada, Japan, Europe, Asia-Pacific
(excluding Japan), Latin America and Rest of World Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2003 through 2008 (includes corresponding
Graph/Chart) II-154

Table 31: World 15-Year Perspective for Reconstructive Sector
by Geographic Region - Percentage Breakdown of Dollar Sales
for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan),
Latin America and Rest of World Markets for Years 2003, 2011 &
2017 (includes corresponding Graph/Chart) II-155

Table 32: World Recent Past, Current & Future Analysis for
Reconstructive Sector by Product Segment - Hip Implants, Knee
Implants and Extremities Markets Independently Analyzed with
Annual Sales Figures in US$ Million for Years 2009 through
2017 (includes corresponding Graph/Chart) II-156

Table 33: World Historic Review for Reconstructive Sector by
Product Segment - Hip Implants, Knee Implants and Extremities
Markets Independently Analyzed with Annual Sales Figures in
US$ Million for Years 2003 through 2008 (includes
corresponding Graph/Chart) II-157

Table 34: World 15-Year Perspective for Reconstructive Sector
by Product Segment - Percentage Breakdown of Dollar Sales for
Hip Implants, Knee Implants and Extremities Markets for Years
2003, 2011 & 2015 (includes corresponding Graph/Chart) II-158

Table 35: World Recent Past, Current & Future Analysis for
Fracture Fixation by Geographic Region - US, Canada, Japan,
Europe, Asia-Pacific (excluding Japan), Latin America & Rest
of World Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2009 through 2017 (includes
corresponding Graph/Chart) II-159

Table 36: World Historic Review for Fracture Fixation by
Geographic Region - US, Canada, Japan, Europe, Asia- Pacific
(excluding Japan), Latin America & Rest of World Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2003 through 2008 (includes corresponding
Graph/Chart) II-160

Table 37: World 15-Year Perspective for Fracture Fixation by
Geographic Region - Percentage Breakdown of Dollar Sales for
US, Canada, Japan, Europe, Asia- Pacific (excluding Japan),
Latin America and Rest of World Markets for Years 2003, 2011 &
2017 (includes corresponding Graph/Chart) II-161

Table 38: World Recent Past, Current & Future Analysis for
Arthroscopy Products by Geographic Region - US, Canada, Japan,
Europe, Asia-Pacific (excluding Japan), Latin America & Rest
of World Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2009 through 2017 (includes
corresponding Graph/Chart) II-162

Table 39: World Historic Review for Arthroscopy Products by
Geographic Region - US, Canada, Japan, Europe, Asia-Pacific
(excluding Japan), Latin America & Rest of World Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2003 through 2008 (includes corresponding
Graph/Chart) II-163

Table 40: World 15-Year Perspective for Arthroscopy Products
by Geographic Region - Percentage Breakdown of Dollar Sales
for US, Canada, Japan, Europe, Asia-Pacific (excluding Japan),
Latin America and Rest of World Markets for Years 2003, 2011 &
2017 (includes corresponding Graph/Chart) II-164

Table 41: World Recent Past, Current & Future Analysis for
Spinal Products by Geographic Region - US, Canada, Japan,
Europe, Asia-Pacific (excluding Japan), Latin America and Rest
of World Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2009 through 2017 (includes
corresponding Graph/Chart) II-165

Table 42: World Historic Review for Spinal Products by
Geographic Region - US, Canada, Japan, Europe, Asia- Pacific
(excluding Japan), Latin America and Rest of World Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2003 through 2008 (includes corresponding
Graph/Chart) II-166

Table 43: World 15-Year Perspective for Spinal Products by
Geographic Region -Percentage Breakdown of Dollar Sales for
US, Canada, Japan, Europe, Asia-Pacific (excluding Japan),
Latin America and Rest of World Markets for Years 2003, 2011 &
2017 (includes corresponding Graph/Chart) II-167

Table 44: World Recent Past, Current & Future Analysis for
Other Orthopedic Instrumentation Products by Geographic Region
- US, Canada, Japan, Europe, Asia- Pacific (excluding Japan),
Latin America and Rest of World Markets Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2009
through 2017 (includes corresponding Graph/Chart) II-168

Table 45: World Historic Review for Other Orthopedic
Instrumentation Products by Geographic Region - US, Canada,
Japan, Europe, Asia-Pacific (excluding Japan), Latin America
and Rest of World Markets Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2003 through 2008
(includes corresponding Graph/Chart) II-169

Table 46: World 15-Year Perspective for Other Products by
Geographic Region - Percentage Breakdown of Dollar Sales for
US, Canada, Japan, Europe, Asia-Pacific (excluding Japan),
Latin America and Rest of World Markets for Years 2003, 2011 &
2017 (includes corresponding Graph/Chart) II-170


III. MARKET

1. THE UNITED STATES III-1
A.Market Analysis III-1
The Largest Orthopedics Market III-1
Proposed Tax on Medical Device Industry - Potential
Implications III-1
An Overview of the US Orthopedic Healthcare System III-2
Table 47: US Orthopedics Market (2008): Percentage Share
Breakdown of Number of Physician Visits for Back, Knee,
Neck, Lower Back, Hip, and Small Bone and Joint (includes
corresponding Graph/Chart) III-2

Table 48: Rate of Procedures (Per 10,000 Individuals) for
Knee Arthroplasty, Hip Replacement, and Spinal Fusion:
Breakdown by Age Group (includes corresponding Graph/Chart) III-3
Trends & Issues III-3
Aging Population & Obesity Drive Demand for Orthopedic
Procedures III-3
Table 49: Primary Hip and Knee Replacement Procedures in
the US (2008): Percentage Breakdown by Age Group (includes
corresponding Graph/Chart) III-4

Table 50: Percentage of Population by Age Group in the US
(2010) (includes corresponding Graph/Chart) III-4
Table 51: US Population in the Over-45 Years Age Group (
2006-2008) (includes corresponding Graph/Chart) III-4
Technological Developments Promote Growth III-5
Biomaterials Market - Keeping Pace with Changing Times III-5
Orthopedic Soft Tissue Allograft Market in the US III-5
Rising Incidence of Arthritis Aids Growth in Implant
Procedures III-6
Orthopedic Implants Market in the US III-6
Wear Debris-A Major Concern III-7
Reimbursement Scenario III-7
CMS Implements MS-DRG System III-7
New FY 2010-2011 Provisions III-8
Main Additions to the MCC and CC Lists for Fiscal-year 2010 III-9
MS-DRG System for Joint Replacements in comparison with
DRG System III-9
MS-DRG System for Spine Segment in comparison with DRG System III-10
Table 52: Comparison of RW and GMLOS for DRG and MS-DRG
Systems (2007-2010) III-11
Reimbursement for Trauma Procedures in the Past III-12
Table 53: Medicare Reimbursement Codes for Leading Trauma
Procedures in US (includes corresponding Graph/Chart) III-12
Table 54: Percentage Change in Medicare Reimbursement
Rates (2000-2005) (includes corresponding Graph/Chart) III-13
Reconstructive Market: An Overview III-13
Large Joint Reconstructive Implants Market - An Overview III-13
An Insight into the Hip and Knee Replacement Market III-14
Innovative Products & Procedures Favor Growth III-14
Hip Resurfacing Implants Market in the US III-15
Joint Replacement Procedures - Improving Technologies &
Materials III-16
Knee Implants Market III-16
Knee Implant Pricing Scenario III-16
Table 55: Knee Replacements in the US (1998-2008): Number
of Procedures (in Thousands) and Average Duration of
Hospitalization for Total, and Revision Knee Replacement
Procedures (includes corresponding Graph/Chart) III-17
Hip Implants Market III-17
New Materials Emerge as Polyethylene Alternatives III-18
Historic Note (Knee and Hip Implants) III-18
Table 56: Knee Implants Market in the US (2004):
Percentage Breakdown by Dollar Sales for Implant Type -
Cemented Femoral, Cemented Tibial, Cementless Femoral,
Cementless Tibial and Polyethylene Liner (includes
corresponding Graph/Chart) III-18

Table 57: Hip Replacements in the US (1998-2005): Number
of Procedures (in Thousands) and Average Duration of
Hospitalization for Total, Partial and Revision Procedures
(includes corresponding Graph/Chart) III-19
Shift from Cemented to Press-Fit Procedures III-19
Cost Containment for Implants III-19
Fracture Fixation Market III-19
Table 58: Number of Inpatient Fracture Repair Procedures in
the US (2008): Percentage Breakdown by Anatomical Site for
Femur, Tibia/Fibula, Radius/ Ulna, Humerus, Face,
Ankle/Foot, Others (includes corresponding Graph/Chart) III-20
Shift Towards LCPs Drive Growth III-20
Domestic Arthroscopy Market to Witness Modest Growth III-20
Spinal Products Market III-21
Troubled Backs III-22
Spinal Procedures in US Witness Substantial Growth III-22
Table 59: Spinal Implant Procedures in the US: 2001- 2008
(includes corresponding Graph/Chart) III-23
Artificial Disc Replacement III-24
Extremities Market III-24
Bone Graft Market III-24
Competitive Landscape III-25
Table 60: Leading Players in the US Reconstructive Implants
Market (2007): Percentage Share Breakdown of Revenues for
Zimmer, DePuy, Stryker, Biomet, Smith & Nephew, Wright
Medical and Others (includes corresponding Graph/Chart) III-26

Table 61: Leading Players in the US Hip Implants Market
(2007): Percentage Share Breakdown of Revenues for Zimmer,
DePuy, Stryker, Smith & Nephew, Biomet, Wright Medical and
Others (includes corresponding Graph/Chart) III-26

Table 62: Leading Players in the US Knee Reconstruction
Market (2007): Percentage Share Breakdown of Revenues for
Zimmer, DePuy, Stryker, Biomet, Smith & Nephew, Wright
Medical and Others (includes corresponding Graph/Chart) III-26

Table 63: Leading Players in the US Spinal Implants Market
(2006): Percentage Breakdown of Value Sales for Medtronic
Sofamor Danek, DePuy Spine, Zimmer Spine, Synthes, Stryker
Biomet and Others (includes corresponding Graph/Chart) III-27
B.Market Analytics III-28
Table 64: US Recent Past, Current & Future Analysis for
Orthopedic Instrumentation by Product Segment -
Reconstructive Sector (Hip Implants, Knee Implants and
Extremities), Fracture Fixation, Arthroscopy, Spinal
Products and Other Orthopedic Products Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2009 through 2017 (includes corresponding Graph/Chart) III-28

Table 65: US Historic Review for Orthopedic Instrumentation
by Product Segment - Reconstructive Sector (Hip Implants,
Knee Implants and Extremities), Fracture Fixation,
Arthroscopy, Spinal Products and Other Orthopedic Products
Markets Independently Analyzed with Annual Sales Figures in
US$ Million for Years 2003 through 2008 (includes
corresponding Graph/Chart) III-29

Table 66: US 15-Year Perspective for Orthopedic
Instrumentation by Product Segment - Percentage Breakdown of
Dollar Sales for Reconstructive Sector (Hip Implants, Knee
Implants and Extremities), Fracture Fixation, Arthroscopy,
Spinal Products and Other Orthopedic Products Markets for
Years 2003, 2011 & 2017 (includes corresponding Graph/Chart) III-30

2. CANADA III-31
A.Market Analysis III-31
Orthopedics Market - An Overview