Spinal Surgical Devices: Technologies and Global Markets

Report Summary

THIS REPORT CONTAINS

• A focus on how nonfusion products, including dynamic stabilization (or motion-preservation) devices and total disc replacement (TDR) are becoming the treatments of choice, especially for younger, more-active patients
• Analysis of the global spinal devices market, with data for 2008, estimates for 2009, and projections of compound annual growth rates (CAGRs) through 2014
• A breakdown of end-user markets, including hospitals, research facilities, freestanding spinal care clinics, and outpatient centers
• An overview of the history and current state of medical spinal fusion and nonfusion devices
• Comprehensive patent analyses.

INTRODUCTION

Most people at one point or another have experienced back pain. The pain usually lasts for only a short duration and then resolves itself with little or no medical attention. For others, however, the pain is unresolving, chronic, and severe, and may involve neurological symptoms, including radiating pain or numbness down an arm or leg. For these relatively few sufferers, surgical intervention may be necessary.

As individuals age, the effects of wear and tear on the body accumulate. This is true of the spine. Degenerative changes, not a single traumatic blow, are the cause of most cases that result in spinal surgery. These degenerative changes can be evidenced radiographically in nearly all people, although only a small percentage of these changes will produce symptomatic conditions. The world’s population is aging at an unprecedented rate, and as this continues, the rate of degenerative spinal conditions is also expected to escalate.

Surgical treatment of spinal conditions has been marred in controversy. Fusion, a treatment largely abandoned by other orthopedic disciplines because of the resulting limited range of motion, is still the treatment of choice for spinal surgical intervention. Innovation in both devices and techniques in spine surgery was largely stagnant in the 1980s and early 1990s. Technological advances in both surgical approaches and spinal implants, however, are once again flourishing, making spine the fastest-growing segment of the global orthopedics market.

This growth, although driven in part by escalating procedural volume, is also the result of excitement in emerging technologies in the non-fusion, or motion-preservation, segment. Initial euphoria has been dampened both by hardware durability issues and reimbursement challenges, but hope persists that the motion preservation market will drive future expansion in the spine industry through positive patient outcomes and economic efficiencies resulting from less-invasive surgeries. Biologics is another rapidly evolving segment of spinal orthopedics that is garnering great enthusiasm. Its growth prospects are high for making current techniques more effective and possibly altering the future landscape of spine surgery with the creation of technologies that actually regenerate spinal components.

STUDY GOALS AND OBJECTIVES

The technologies in this report—implantable spinal prosthetics and hardware—are pivotal to improving the quality of life for the tens of millions worldwide who suffer from back pain and neurological deficit resulting from common spinal conditions. Advances in these devices and their implantation techniques can improve the cost benefit of treatment of spinal conditions.

The objectives of this report are to present a comprehensive analysis of the market for these orthopedic products and forecast their commercial potential through 2015.

This report will:

• Assess the prevalence of common spinal conditions and trends affecting their projected future incidence
• Examine current procedure volumes and associated expenditures, as well as projected increases in demand by technique
• Analyze the current market and forecast demand for implantable spinal surgical devices
• Describe the regulatory framework and its effect on the introduction of new devices into the spinal market both in the U.S. and abroad
• Analyze trends in patent applications and issued patents for innovations that will be altering the spinal marketplace
• Examine the drivers that will affect future utilization and rate of adoption of the implants, including demographic changes, reimbursement policy, clinical considerations, and R&D
• Identify the product manufacturers that will drive innovation, their market share, and other industry players

REASONS FOR DOING THE STUDY

The world’s population is aging at an unprecedented rate. Aging populations face increased rates of arthritic and degenerative conditions. This trend is particularly pronounced upon examination of the prevalence of back pain and underlying spinal conditions.

The convergence of the following trends represents the motivation for this report:

• The worldwide growth of the senior population will strain the capabilities of healthcare providers and the financial resources of healthcare payers.
• Patients are increasingly less likely to accept “aging pains” as they wish to maintain a more active lifestyle even with advancing age.
• Obesity, which is also increasing globally, will similarly contribute to higher rates of back pain and degenerative conditions.
• Advances in biologics, materials, imaging techniques, and the biomechanical understanding of the spine will enable treatment of spinal conditions with a focus on preservation of natural range of motion.
• To contain costs while simultaneously facing an increased procedural volume, focus is shifting toward improving instruments and techniques to reduce the invasiveness of surgery, thereby shortening hospital stays and hastening recovery.
• Increased focus is being placed on the cost benefit of surgical procedures and implants.

SCOPE OF REPORT

This report is a business analysis that has the primary purpose of examining trends in the market for spinal surgical devices, specifically arthroplasty products and implanted instrumentation hardware. The report includes sections on the following topics:

• Current prevalence of common spinal problems, trend analysis, and factors influencing future incidence
• Market analysis by surgical procedure, including annual incidence, trend analysis, and factors influencing future predicted surgical volume
• Global demand by device and projected future trends by device category
• Risk factors and other drivers that will affect the future incidence of spine surgery and related utilization of spinal surgical devices
• U.S. and international regulation of spinal devices
• Patent analysis
• Market share and information on key device manufacturers

Table of Contents

CHAPTER ONE: INTRODUCTION

INTRODUCTION

STUDY GOALS AND OBJECTIVES

REASONS FOR DOING THE STUDY

SCOPE OF REPORT

INTENDED AUDIENCE

INFORMATION SOURCES

ANALYST CREDENTIALS

RELATED BCC REPORTS

BCC ONLINE SERVICES

DISCLAIMER

 

CHAPTER TWO: SUMMARY

SUMMARY

SUMMARY TABLE GLOBAL FORECAST SPINAL SURGICAL DEVICES BY CATEGORY, THROUGH 2015 ($ MILLIONS)

SUMMARY FIGURE GLOBAL FORECAST SPINAL SURGICAL DEVICES BY CATEGORY, 2008-2015 ($ MILLIONS)

CHAPTER THREE: OVERVIEW

SPINAL ANATOMY

SPINAL COLUMN

Intervertebral Discs

Boney Structures

NEURAL ELEMENTS

SUPPORTING STRUCTURES

TABLE 1 FUNCTIONAL ROLE OF THE SPINAL COLUMN COMPONENTS

BACK PAIN

HISTORY OF BACK PAIN AND EARLY TREATMENT

BACK PAIN TODAY

TABLE 2 GLOBAL SAMPLING OF FREQUENCY OF BACK PAIN, 2002-2009

Cost of Back Pain

TABLE 3 U.S. MEDICAL ENCOUNTERS BY SETTING FOR THE DIRECT TREATMENT OF BACK PROBLEMS, 2007 (THOUSANDS)

TABLE 4 HOSPITAL DISCHARGES BY BACK-RELATED DIAGNOSIS IN SELECT EUROPEAN COUNTRIES, THROUGH 2008

TABLE 5 U.S. DIRECT MEDICAL EXPENSES FOR BACK PROBLEMS, 2007 ($ MILLIONS)

TABLE 6 U.S. DISTRIBUTION OF DIRECT BACK-RELATED MEDICAL EXPENSES BY PAYER, 2007 (%)

TABLE 7 U.S. PATIENTS WITH BACK PROBLEMS, THROUGH 2007 (MILLIONS)

TABLE 8 U.S. MEDICAL EXPENDITURES FOR THE DIRECT TREATMENT OF BACK PROBLEMS, THROUGH 2007 ($ BILLIONS)

Disability from Back Pain

Identifying the Cause of Back Pain

TABLE 9 DISTRIBUTION OF DIAGNOSABLE BACK CONDITIONS (%)

Causes of Diagnosed Back Pain

Risk Factors for Back Pain

Risk Factors for Diagnosable Back Disorders

Genetics

Aging

TABLE 10 PROJECTED AGING OF THE GLOBAL POPULATION AGE 65 AND OLDER, THROUGH 2020 (MILLION)

Smoking

Obesity

TABLE 11 GLOBAL PREVALENCE OF OBESITY, 1995-2005 (%)

Osteoporosis

TABLE 12 PROJECTED AGING OF GLOBAL FEMALE POPULATION AGE 60-99, THROUGH 2020 (MILLION)

COMMON SPINAL CONDITIONS

TABLE 13 DIAGNOSIS-RELATED ICD 9 CODES FOR SPINAL CONDITIONS

TABLE 14 U.S. INPATIENTS DIAGNOSED BY CODED BACK CONDITIONS, 2008

ABNORMAL SPINAL CURVATURES

TABLE 15 U.S. TREND FOR INPATIENT DIAGNOSIS OF ALL ABNORMAL CURVATURES OF THE SPINE, THROUGH 2015

TABLE 16 U.S. INPATIENTS WITH ABNORMAL CURVATURES OF THE SPINE, 2008

Kyphosis

Postural Kyphosis

Structural Kyphosis

Gibbus Deformity

Scheuermann’s Disease

Congenital Kyphosis

Secondary Kyphosis

Treatment

TABLE 17 GLOBAL FREQUENCY OF KYPHOSIS

TABLE 18 U.S. AGE DISTRIBUTION FOR INPATIENTS DIAGNOSED WITH KYPHOSIS, 2008 (%)

TABLE 19 U.S. TREND OF HOSPITAL INPATIENT DIAGNOSIS OF KYPHOSIS, THROUGH 2015

Lordosis

Treatment

TABLE 20 U.S. TREND FOR HOSPITAL INPATIENT DIAGNOSIS OF LORDOSIS, THROUGH 2015

Scoliosis

Congenital Scoliosis

Failure of Segmentation

Failure of Formation

Treatment

Neuromuscular Scoliosis

Treatment

Degenerative Scoliosis

Treatment

Idiopathic Scoliosis

Treatment

TABLE 21 GLOBAL FREQUENCY OF SCOLIOSIS

TABLE 22 U.S. AGE DISTRIBUTION FOR INPATIENTS DIAGNOSED WITH SCOLIOSIS, 2008 (%)

TABLE 23 U.S. TREND FOR HOSPITAL INPATIENT DIAGNOSIS OF SCOLIOSIS, THROUGH 2015

ARTHRITIC SPINAL CONDITIONS

TABLE 24 U.S. TREND FOR HOSPITAL INPATIENTS WITH DIAGNOSES OF ALL ARTHRITIS-RELATED SPINAL CONDITIONS, THROUGH 2015

TABLE 25 U.S. INPATIENTS WITH ARTHRITIS-RELATED SPINAL CONDITIONS, BY CONDITION, 2008

Ankylosing Spondylitis

TABLE 26 GLOBAL FREQUENCY OF ANKYLOSING SPONDYLITIS (%)

Rheumatoid Arthritis

TABLE 27 GLOBAL FREQUENCY OF RHEUMATOID ARTHRITIS (%)

TABLE 28 AGE DISTRIBUTION FOR INPATIENTS DIAGNOSED WITH ANKYLOSING SPONDYLITIS/RHEUMATOID ARTHRITIS (%)

TABLE 29 U.S. TREND FOR HOSPITAL INPATIENT DIAGNOSES OF ANKYLOSING SPONDYLITIS/RHEUMATOID ARTHRITIS, THROUGH 2015

Osteoarthritis/Spondylosis

TABLE 30 U.S. DISTRIBUTION OF SPONDYLOSIS BY SPINAL REGION, 2008

Treatment

TABLE 31 U.S. AGE DISTRIBUTION FOR INPATIENTS DIAGNOSED WITH SPONDYLOSIS, 2008 (%)

TABLE 32 U.S. TREND FOR HOSPITAL INPATIENT DIAGNOSIS OF SPONDYLOSIS, THROUGH 2015

DEGENERATIVE DISC DISEASES

TABLE 33 U.S. TREND FOR HOSPITAL INPATIENT DIAGNOSES WITH ALL DEGENERATIVE DISC DISEASES, THROUGH 2015 (THOUSANDS)

TABLE 34 U.S. INPATIENTS DIAGNOSED WITH DEGENERATIVE DISC DISORDERS, 2008

Disc Herniation

TABLE 35 U.S. DISTRIBUTION OF DISC HERNIATION BY SPINAL REGION, 2008 (%)

TABLE 36 U.S. AGE DISTRIBUTION FOR INPATIENTS DIAGNOSED WITH DISC HERNIATION, 2008 (%)

TABLE 37 U.S. TREND FOR INPATIENT DIAGNOSIS OF DISC HERNIATION, THROUGH 2015 (%)

Treatment

Disc Degeneration

TABLE 38 U.S. DISTRIBUTION OF DEGENERATIVE DIAGNOSIS BY REGION OF THE SPINE, 2008 (%)

TABLE 39 U.S. AGE DISTRIBUTION FOR INPATIENTS DIAGNOSED WITH DEGENERATION OF THE INTERVERTEBRAL DISCS, 2008 (%)

TABLE 40 U.S. TREND FOR INPATIENT DIAGNOSIS OF DEGENERATION OF THE INTERVERTEBRAL DISC, THROUGH 2015 (%)

Spinal Stenosis

TABLE 41 U.S. DISTRIBUTION OF STENOSIS BY SPINAL REGION, 2008 (%)

TABLE 42 U.S. AGE DISTRIBUTION FOR INPATIENTS DIAGNOSED WITH SPINAL STENOSIS, 2008 (%)

TABLE 43 U.S. TREND INPATIENT DIAGNOSIS OF SPINAL STENOSIS, THROUGH 2015

Treatment

Spondylolisthesis

TABLE 44 U.S. AGE DISTRIBUTION FOR INPATIENTS DIAGNOSED WITH SPONDYLOLISTHESIS, 2008 (%)

Treatment

TABLE 45 U.S. TREND IN INPATIENT DIAGNOSIS OF SPONDYLOLISTHESIS, THROUGH 2015

SPINAL TUMORS

Treatment

INJURY

Vertebral Fractures

TABLE 46 U.S. INPATIENTS WITH VERTEBRAL FRACTURE DIAGNOSIS, 2008

TABLE 47 U.S. AND E.U. VERTEBRAL FRACTURES BY TYPE

TABLE 48 U.S. AGE DISTRIBUTION FOR INPATIENTS DIAGNOSED WITH VERTEBRAL FRACTURES WITHOUT SPINAL CORD INJURY, 2008 (%)

TABLE 49 U.S. TREND FOR INPATIENT DIAGNOSIS OF VERTEBRAL FRACTURE, THROUGH 2015 (%)

Fracture Classification

Major/Minor

Stable/Unstable

Denis 3-Column Model

Break Type

Traumatic Spinal Injury

TRENDS IN FREQUENCY OF SPINAL CONDITIONS

TABLE 50 U.S. FORECAST FOR INPATIENT DIAGNOSIS BY CODED SPINAL CONDITION, THROUGH 2015 (THOUSANDS)

CHAPTER FOUR: MARKET ANALYSIS

MARKET BY APPLICATION OR PROCEDURE

TABLE 51 U.S. SPINAL PROCEDURES BY VOLUME, THROUGH 2015 (THOUSANDS)

TABLE 52 U.S. COSTS FOR ALL SPINAL PROCEDURES, THROUGH 2015 ($ MILLIONS)

TABLE 53 U.S. DISTRIBUTION OF SPINAL SURGERY PROCEDURES BY CATEGORY, 2008 (%)

TABLE 54 U.S. HIGHEST MEAN COSTS BY SPINAL SURGICAL PROCEDURE, 2008 ($)

TABLE 55 PROCEDURAL ICD 9 CODES

DECOMPRESSION

TABLE 56 U.S. FORECAST VOLUME FOR DECOMPRESSION PROCEDURES, THROUGH 2015

TABLE 57 U.S. FORECAST TOTAL COSTS FOR ALL DECOMPRESSION PROCEDURES, THROUGH 2015 ($ MILLIONS)

Discectomy

TABLE 58 U.S. AGE DISTRIBUTION IN PATIENTS ADMITTED FOR DISCECTOMIES, 2008 (%)

TABLE 59 U.S. REDUCTION IN MEAN LENGTH OF STAY FOR DISCECTOMIES AS PRIMARY PROCEDURE, 2000 AND 2008

(DAYS)

TABLE 60 U.S. FORECAST VOLUME OF DISCECTOMIES, THROUGH 2015

TABLE 61 U.S. FORECAST MEAN COSTS PER DISCECTOMIES, THROUGH 2015 ($)

TABLE 62 U.S. COMPARISON OF TOTAL COSTS FOR ALL DISCECTOMIES, 2007-2015 ($ MILLIONS)

Microdiscectomies

Percutaneous Discectomy Procedures

Percutaneous Automated Discectomy

Percutaneous Laser Discectomy

Percutaneous Arthroscopic Discectomy

Nucleoplasty

Chemonucleolysis

Foraminotomy

Laminotomy/Laminectomy

TABLE 63 U.S. AGE DISTRIBUTION IN PATIENTS ADMITTED FOR LAMINOTOMY/FORAMINOTOMY, 2008 (%)

TABLE 64 U.S. FORECAST VOLUME OF LAMINOTOMIES/FORAMINOTOMIES, THROUGH 2015

TABLE 65 U.S. FORECAST MEAN COSTS OF LAMINOTOMIES/FORAMINOTOMIES, THROUGH 2015 ($)

TABLE 66 U.S. COMPARISON OF TOTAL COSTS FOR ALL LAMINOTOMIES/FORAMINOTOMIES, 2007-2015 ($ MILLIONS)

Post-Laminectomy Syndrome

TABLE 67 U.S. AGE DISTRIBUTION OF PATIENTS ADMITTED FOR POST-LAMINECTOMY SYNDROME, 2008 (%)

TABLE 68 U.S. POST-LAMINECTOMY SYNDROME ADMISSIONS BY SPINAL REGION, 2008 (%)

Corpectomy

TABLE 69 U.S. AGE DISTRIBUTION IN PATIENTS ADMITTED FOR CORPECTOMIES, 2008 (%)

TABLE 70 U.S. FORECAST VOLUME OF CORPECTOMIES, THROUGH 2015

TABLE 71 U.S. FORECAST OF MEAN COSTS FOR CORPECTOMIES, THROUGH 2015 ($ THOUSANDS)

TABLE 72 U.S. COMPARISON OF TOTAL COSTS FOR ALL CORPECTOMIES, 2007-2015 ($ MILLIONS)

MINIMALLY INVASIVE PROCEDURES

Interventional Spine Care

FRACTURE REPAIR

TABLE 73 U.S. AGE DISTRIBUTION FOR FRACTION REPAIR ADMISSIONS, 2008 (%)

TABLE 74 U.S. FORECAST FOR TOTAL VOLUME OF FRACTURE REPAIR, THROUGH 2015

TABLE 75 U.S. FORECAST FOR TOTAL COSTS FOR ALL FRACTURE REPAIR, THROUGH 2015 ($ MILLIONS)

Vertebroplasty

TABLE 76 U.S. FORECAST VOLUME OF ADMISSIONS FOR VERTEBROPLASTY, THROUGH 2015

TABLE 77 U.S. FORECAST OF MEAN COSTS FOR VERTEBROPLASTY, THROUGH 2015 ($)

TABLE 78 U.S. COMPARISON OF TOTAL COSTS FOR ALL VERTEBROPLASTY, 2007-2015 ($ MILLIONS)

Kyphoplasty

TABLE 79 U.S. FORECAST VOLUME OF ADMISSIONS FOR KYPHOPLASTY, THROUGH 2015

TABLE 80 U.S. FORECAST OF MEAN COSTS FOR KYPHOPLASTY, THROUGH 2015 ($)

TABLE 81 U.S. COMPARISON OF TOTAL COSTS FOR ALL KYPHOPLASTY, 2007-2015 ($ MILLIONS)

FUSION

TABLE 82 U.S. FORECAST VOLUME OF ALL FUSIONS, THROUGH 2015

TABLE 83 U.S. FORECAST OF TOTAL COSTS FOR ALL FUSION ADMISSIONS, THROUGH 2015 ($ MILLIONS)

TABLE 84 U.S. TOTAL FORECAST VOLUME OF FUSIONS BY LEVEL, THROUGH 2015

TABLE 85 U.S. FORECAST OF MEAN FUSION COSTS BY LEVEL, THROUGH 2015 ($)

TABLE 86 U.S. FORECAST OF TOTAL COSTS FOR ALL FUSIONS BY LEVEL, THROUGH 2015 ($ MILLIONS)

FIGURE 1 COMPARISON OF TOTAL COSTS FOR ALL FUSION, 2007-2015 ($ MILLIONS)

TABLE 87 U.S. AGE DISTRIBUTION FOR ALL FUSIONS, 2000 AND

2008 (%)

TABLE 88 U.S. TRENDS FOR COMPLEX FUSIONS BY AGE, THROUGH 2008

TABLE 89 U.S. COMPARISON OF AGE DISTRIBUTION FOR COMPLEX FUSION, 2006 AND 2008

TABLE 90 U.S. FORECAST OF FUSION VOLUME BY COMPLEXITY LEVEL, THROUGH 2015

TABLE 91 U.S. DISTRIBUTION OF ALL FUSIONS BY SPINAL LEVEL, 2008

TABLE 92 U.S. FUSIONS BY APPROACH, 2008

Instrumented Fusion

Pedicle Screw Fixation

Anterior Cervical Plate System

Interior Fusion Devices

Vertebral Body Replacement

Lumbar Interbody Fusion Devices

TABLE 93 U.S. TOTAL VOLUME FOR IBFD AND FUSION, THROUGH 2008

TABLE 94 U.S. PROJECTED VOLUME FOR IBFD, THROUGH 2015

TABLE 95 U.S. PROJECTED MEAN COST OF IBFD, THROUGH 2015 ($)

TABLE 96 U.S. PROJECTED TOTAL COST FOR ALL IBFD, THROUGH 2015 ($ MILLIONS)

FIGURE 2 U.S. COMPARISON TOTAL COSTS FOR ALL IBFD, 2007-2015 ($ MILLIONS)

TABLE 97 U.S. AGE DISTRIBUTION FOR IBFD, 2008 (%)

Posterior Lumbar Interbody Fusion

Transforaminal Lumbar Interbody Fusion

Anterior Lumbar Interbody Fusion

eXtreme Lateral Interbody Fusion and Direct Lateral Interbody Fusion

Bone Grafts

Autograft

TABLE 98 ANNUAL FREQUENCY OF USE OF BIOLOGICS WORLDWIDE

Osteoconductive Substitutes

Allograft

Bone Graft Substitute

Osteoinductive Substitutes

Demineralized Bone Matrix

Platelet Helpers

Growth Factors

Future of Biologics

COMPLICATIONS OF SPINAL FUSION

Revision Surgery

TABLE 99 U.S. DISTRIBUTION OF REVISION SURGERIES BY LEVEL, 2008

TABLE 100 U.S. PROJECTED VOLUME OF REVISION SURGERIES BY LEVEL, THROUGH 2015

TABLE 101 U.S. PROJECTED MEAN COST OF REVISION SURGERY BY LEVEL, THROUGH 2015 ($)

TABLE 102 U.S. TOTAL COSTS FOR ALL REVISION SURGERIES BY LEVEL, THROUGH 2015 ($ MILLIONS)

FIGURE 3 U.S. COMPARISON OF TOTAL COSTS FOR ALL REVISION SURGERIES, 2007-2015 ($ MILLIONS)

NON-FUSION/MOTION PRESERVING SURGERIES

Posterior Motion Preservation

TABLE 103 U.S. TOTAL VOLUME OF POSTERIOR MOTION PRESERVATION, 2008

Interspinous Process Spacers

TABLE 104 U.S. FORECAST OF TOTAL VOLUME INTERSPINOUS PROCESS SPACERS, THROUGH 2015

TABLE 105 U.S. FORECAST OF MEAN COST INTERSPINOUS PROCESS SPACERS, THROUGH 2015 ($)

TABLE 106 U.S. FORECAST OF TOTAL COST INTERSPINOUS PROCESS SPACERS, THROUGH 2015 ($ THOUSANDS)

Posterior Dynamic Stabilization

TABLE 107 U.S. TOTAL VOLUME OF POSTERIOR DYNAMIC STABILIZATION, THROUGH 2008

Facet Replacement

Anterior Motion Preservation

Arthroplasty

Total Disc Replacement

TABLE 108 U.S. TOTAL DISC REPLACEMENT VOLUME BY SPINAL LEVEL 2007 AND 2008

Disc Nucleus Replacement

TABLE 109 U.S. VOLUME NUCLEUS REPLACEMENT, 2008

MARKET BY DEVICE

TABLE 110 GLOBAL FORECAST FOR SPINAL SURGICAL DEVICES, THROUGH 2015 ($ MILLIONS)

TABLE 111 GLOBAL FORECAST FOR FUSION DEVICES, THROUGH 2015 ($ MILLIONS)

TABLE 112 GLOBAL FORECAST FOR FRACTURE REPAIR, THROUGH 2015 ($ MILLIONS)

TABLE 113 GLOBAL FORECAST FOR NON-FUSION DEVICES, THROUGH 2015 ($ MILLIONS)

TABLE 114 GLOBAL FORECAST FOR ARTHROPLASTY, THROUGH 2015 ($ MILLIONS)

TRENDS AFFECTING UTILIZATION OF SPINAL SURGICAL DEVICES

Technological Changes

Economic Considerations

Outpatient Surgical Centers

Regulation

INDUSTRY STRUCTURE

REGULATION

U.S. Regulation

Device Regulation

Food and Drug Administration

510(k) Clearance

TABLE 115 FREQUENTLY FDA-CLEARED SPINAL IMPLANTS, BY DEVICE, 2000-2009

TABLE 116 510(K) FILINGS BY THE LARGEST SPINE COMPANIES, 2000-2009

Premarket Approval

Investigational Device Exemption

Humanitarian Device Exemption

European Regulation

CE Mark

European Commission

International Standards Organization

Tissue Regulation

American Association of Tissue Banks

Accredited Processers of Allograft

Clinical Trials

TABLE 117 ACTIVE CLINICAL TRIALS FOR SPINAL SURGERY DEVICES

PATENT EVALUATION

TABLE 118 SPINE-RELATED PATENT SUB-CLASSIFICATIONS

TABLE 119 SPINAL PATENTS ISSUED AND APPLIED BY YEAR, 2001-JUNE 1, 2010

TABLE 120 PATENTS ISSUED AND APPLIED BY SUBCLASS 2001-JUNE 1, 2010

PLAYERS

TABLE 121 MAJOR PLAYERS BY REVENUE, 2009 ($ MILLIONS)

TABLE 122 SPINAL SURGICAL DEVICE COMPANY BANKRUPTCIES, 2009

CHAPTER FIVE: INDUSTRY PLAYERS

FUSION

POSTERIOR PEDICLE SCREW FUSION SYSTEMS

Aesculap

Alphatec Spine, Inc.

Amedica Corp.

Biomet Spine

Cardo Medical, Inc.

Choice Spine, LP

Co-Ligne Ag

DePuy Spine, Inc.

Eden Spine, LLC

Exactech, Inc.

Globus Medical, Inc.

Innovasis, Inc.

Integra Spine

Interventional Spine, Inc.

Lanx, Inc.

LDR Médical

Life Spine

Medicrea International

Medtronic, Inc.

Neuro France Implants

NuVasive, Inc.

Ortho Development Corp.

Orthofix International N.V.

Pioneer Surgical Technology

Scient’X Group S.A.S.

SeaSpine, Inc.

Signus Medizintechnik GmbH

Sintea Biotech, SpA

Specialty Spine Products, LLC

Spine Network (Eurosurgical)

SpineVision SA

Stryker Spine

Synthes Inc.

Ulrich GmbH & Co. KG

VertiFlex, Inc.

X-Spine Systems, Inc.

Zimmer Spine, Inc.

CABLE SYSTEMS

Biomet Spine

DePuy Spine, Inc.

Pioneer Surgical Technology

ANTERIOR CERVICAL PLATE SYSTEMS

Aesculap

Alphatec Spine, Inc.

Amedica Corp.

Apollo Spine

Biomet Spine

Cardo Medical Inc.

Choice Spine, LP

DePuy Spine, Inc.

Exactech, Inc.

Globus Medical, Inc.

Innovasis, Inc.

Integra Spine

Lanx, Inc.

Life Spine

NuVasive, Inc.

Ortho Development Corp.

Orthofix International N.V.

Pioneer Surgical Technology

Scient’X Group S.A.S.

SeaSpine, Inc.

Signus Medizintechnik GmbH

Sintea Biotech, SpA

SpineVision SA

Stryker Spine

Synthes Inc.

Ulrich GmbH & Co. KG

X-Spine Systems, Inc.

Zimmer Spine, Inc.

OTHER ANTERIOR FIXATION DEVICES

Alphatec Spine, Inc.

DePuy Spine, Inc.

Eminent Spine

Globus Medical, Inc.

Life Spine

Medicrea International

NuVasive, Inc.

Scient’X Group S.A.S.

SeaSpine, Inc.

Stryker Spine

Synthes Inc.

X-Spine Systems, Inc.

Ulrich GmbH & Co. KG

Zimmer Spine, Inc.

INTERBODY FUSION DEVICES

Vertebral Body Replacement

Aesculap

Alphatec Spine, Inc.

Biomet Spine

Co-Ligne Ag

DePuy Spine, Inc.

Eden Spine, LLC

Globus Medical, Inc.

Innovasis, Inc.

Integra Spine

Ortho Development Corp.

Orthofix International N.V.

Pioneer Surgical Technology

Scient’X Group S.A.S.

Signus Medizintechnik GmbH

SpineVision SA

Spine Wave, Inc.

Stryker Spine

Synthes, Inc.

Ulrich GmbH & Co. KG

Verticor, Ltd.

Metallic Interbody Fusion Devices

Aesculap

Life Spine

Osteotech, Inc.

Medtronic, Inc.

RSB Spine LLC

Scient’X Group S.A.S.

Sintea Biotech, SpA

SpineSelect, LLC

Stryker Spine

Titan Spine, LLC

TranS1, Inc.

Ulrich GmbH & Co. KG

Vertebration, Inc.

Zimmer Spine, Inc.

Polymer Interbody Fusion Devices

Aesculap

Alphatec Spine, Inc.

Amedica Corp.

Biomet Spine

Centinel Spine, Inc.

Choice Spine, LP

Co-Ligne AG

DePuy Spine, Inc.

Eminent Spine

Globus Medical, Inc.

Innovasis, Inc.

Integra Spine

LDR Médical

Lanx, Inc.

Medicrea International

Neuro France Implants

NuVasive, Inc.

Orthofix International N.V.

Scient’X Group S.A.S.

SeaSpine, Inc.

Signus Medizintechnik GmbH

Sintea Biotech, SpA

Spinal Elements

SpineSmith

Synthes Inc.

Ulrich GmbH & Co. KG

Vertebral Technologies, Inc.

Verticor, Ltd.

VertiFlex, Inc.

X-Spine Systems, Inc.

Zimmer Spine, Inc.

Structural Spinal Allografts

AlloSource

Alphatec Spine, Inc.

Biomet Spine

Lanx, Inc.

Ortho Development Corp.

Osteotech, Inc.

Scient’X Group S.A.S.

Stryker Spine

Synthes, Inc.

Zimmer Spine, Inc.

BONE GRAFTS

Demineralized Bone Matrix (DBM)

Alphatec Spine, Inc.

Biomet Spine

Citagenix, Inc.

Etex Corp.

Exactech, Inc.

Integra Spine

Osteotech, Inc.

Synthes, Inc.

Wright Medical Technology, Inc.

BONE GRAFT SUBSTITUTES

Amedica Corp.

Biocomposites, Ltd.

Citagenix, Inc.

DePuy Spine, Inc.

Etex Corp.

Globus Medical, Inc.

Innovasis, Inc.

Integra Spine

LDR Médical

Medicrea International

Medtronic, Inc.

NuVasive, Inc.

Orthovita

Progentix Orthobiology BV

Scient’X Group S.A.S.

Signus Medizintechnik GmbH

Synthes, Inc.

Wright Medical Technology, Inc.

Zimmer Spine, Inc.

PLATELET HELPERS

Stem Cells

Allosource

NuVasive, Inc.

Growth Factors (rhBMP)

BioMimetic Therapeutics, Inc.

Medtronic, Inc.

Stryker Spine

Non-Fusion

Interspinous Process Spacers

Eden Spine, LLC

Globus Medical, Inc.

Interventional Spine, Inc.

Medtronic, Inc.

Paradigm Spine, LLC

Privelop AG

Replication Medical, Inc.

VertiFlex, Inc.

Dynamic Stabilization

Applied Spine Technologies, Inc.

Bio-Spine Corp.

Disc Motion Technologies

Eden Spine, LLC

Paradigm Spine, LLC

Scient’X Group S.A.S.

SpineVision SA

Ulrich GmbH & Co. KG

VertiFlex, Inc.

Zimmer Spine, Inc.

Arthroplasty: Cervical

Aesculap

Globus Medical, Inc.

LDR Médical

Medicrea International

Medtronic, Inc.

NuVasive, Inc.

Orthofix International N.V.

Paradigm Spine, LLC

Scient’X Group S.A.S.

Signus Medizintechnik GmbH

Spinal Kinetics

Spinal Motion

Stryker Corp.

Synthes Inc.

Arthroplasty: Lumbar

Aesculap

AxioMed Spine Corp.

DePuy Spine, Inc.

Disc Motion Technologies

Eden Spine, LLC

Fournitures Hospitalieres Orthopedics

Integra Spine

LDR Médical

Pioneer Surgical Technology

Ranier Technology, Ltd.

Spinal Motion

Synthes Inc.

Zimmer Spine, Inc.

Nucleus Replacement

CryoLife Inc.

Gentis Inc.

Replication Medical, Inc.

Spine Wave, Inc.

TranS1, Inc.

Vertebral Technologies, Inc.

Facet Replacement

Facet Solutions, Inc.

Impliant, Inc.

Interventional Spine, Inc.

Spinal Elements

Vertebral Column Fracture

Alphatec Spine Inc.

ArthoCare Corp.

Benvenue Medical

Biomet Spine

Bone Solutions, Inc.

BoneSupport AB

CareFusion

DePuy Spine, Inc.

DFine, Inc.

Doctors Research Group, Inc.

Mathys, Ltd. Bettlach

Medtronic, Inc.

Orthovita

Sintea Biotech, SpA

SpineAlign Medical, Inc.

Stryker Corp.

Vexim SAS

Annulus Repair

Anulex Technologies, Inc.

Intrinsic Therapeutics, Inc.

Magellan Spine Technologies, Inc.

CHAPTER SIX: REFERENCES

REFERENCES

LIST OF TABLES

SUMMARY TABLE GLOBAL FORECAST SPINAL SURGICAL DEVICES

BY CATEGORY, THROUGH 2015 ($ MILLIONS)

TABLE 1 FUNCTIONAL ROLE OF THE SPINAL COLUMN

COMPONENTS

TABLE 2 GLOBAL SAMPLING OF FREQUENCY OF BACK PAIN, 2002-

2009

TABLE 3 U.S. MEDICAL ENCOUNTERS BY SETTING FOR THE DIRECT

TREATMENT OF BACK PROBLEMS, 2007 (THOUSANDS)

TABLE 4 HOSPITAL DISCHARGES BY BACK-RELATED DIAGNOSIS IN

SELECT EUROPEAN COUNTRIES, THROUGH 2008

TABLE 5 U.S. DIRECT MEDICAL EXPENSES FOR BACK PROBLEMS,

2007 ($ MILLIONS)

TABLE 6 U.S. DISTRIBUTION OF DIRECT BACK-RELATED MEDICAL

EXPENSES BY PAYER, 2007 (%)

TABLE 7 U.S. PATIENTS WITH BACK PROBLEMS, THROUGH 2007

(MILLIONS)

TABLE 8 U.S. MEDICAL EXPENDITURES FOR THE DIRECT

TREATMENT OF BACK PROBLEMS, THROUGH 2007 ($ BILLIONS)

TABLE 9 DISTRIBUTION OF DIAGNOSABLE BACK CONDITIONS (%)

TABLE 10 PROJECTED AGING OF THE GLOBAL POPULATION AGE 65

AND OLDER, THROUGH 2020 (MILLION)

TABLE 11 GLOBAL PREVALENCE OF OBESITY, 1995-2005 (%)

TABLE 12 PROJECTED AGING OF GLOBAL FEMALE POPULATION

AGE 60-99, THROUGH 2020 (MILLION)

TABLE 13 DIAGNOSIS-RELATED ICD 9 CODES FOR SPINAL

CONDITIONS

TABLE 14 U.S. INPATIENTS DIAGNOSED BY CODED BACK

CONDITIONS, 2008

TABLE 15 U.S. TREND FOR INPATIENT DIAGNOSIS OF ALL

ABNORMAL CURVATURES OF THE SPINE, THROUGH 2015

TABLE 16 U.S. INPATIENTS WITH ABNORMAL CURVATURES OF THE

SPINE, 2008

TABLE 17 GLOBAL FREQUENCY OF KYPHOSIS

TABLE 18 U.S. AGE DISTRIBUTION FOR INPATIENTS DIAGNOSED

WITH KYPHOSIS, 2008 (%)

TABLE 19 U.S. TREND OF HOSPITAL INPATIENT DIAGNOSIS OF

KYPHOSIS, THROUGH 2015

TABLE 20 U.S. TREND FOR HOSPITAL INPATIENT

DIAGNOSIS OF LORDOSIS, THROUGH 2015

TABLE 21 GLOBAL FREQUENCY OF SCOLIOSIS

TABLE 22 U.S. AGE DISTRIBUTION FOR INPATIENTS DIAGNOSED

WITH SCOLIOSIS, 2008 (%)

TABLE 23 U.S. TREND FOR HOSPITAL INPATIENT DIAGNOSIS OF

SCOLIOSIS, THROUGH 2015

TABLE 24 U.S. TREND FOR HOSPITAL INPATIENTS WITH

DIAGNOSES OF ALL ARTHRITIS-RELATED SPINAL CONDITIONS,

THROUGH 2015

TABLE 25 U.S. INPATIENTS WITH ARTHRITIS-RELATED SPINAL

CONDITIONS, BY CONDITION, 2008

TABLE 26 GLOBAL FREQUENCY OF ANKYLOSING SPONDYLITIS (%)

TABLE 27 GLOBAL FREQUENCY OF RHEUMATOID ARTHRITIS (%)

TABLE 28 AGE DISTRIBUTION FOR INPATIENTS DIAGNOSED WITH

ANKYLOSING SPONDYLITIS/RHEUMATOID ARTHRITIS (%)

TABLE 29 U.S. TREND FOR HOSPITAL INPATIENT DIAGNOSES OF

ANKYLOSING SPONDYLITIS/RHEUMATOID ARTHRITIS, THROUGH

2015

TABLE 30 U.S. DISTRIBUTION OF SPONDYLOSIS BY SPINAL REGION,

2008

TABLE 31 U.S. AGE DISTRIBUTION FOR INPATIENTS DIAGNOSED

WITH SPONDYLOSIS, 2008 (%)

TABLE 32 U.S. TREND FOR HOSPITAL INPATIENT DIAGNOSIS OF

SPONDYLOSIS, THROUGH 2015

TABLE 33 U.S. TREND FOR HOSPITAL INPATIENT DIAGNOSES WITH

ALL DEGENERATIVE DISC DISEASES, THROUGH 2015

(THOUSANDS)

TABLE 34 U.S. INPATIENTS DIAGNOSED WITH DEGENERATIVE

DISC DISORDERS, 2008

TABLE 35 U.S. DISTRIBUTION OF DISC HERNIATION BY SPINAL

REGION, 2008 (%)

TABLE 36 U.S. AGE DISTRIBUTION FOR INPATIENTS DIAGNOSED

WITH DISC HERNIATION, 2008 (%)

TABLE 37 U.S. TREND FOR INPATIENT DIAGNOSIS OF DISC

HERNIATION, THROUGH 2015 (%)

TABLE 38 U.S. DISTRIBUTION OF DEGENERATIVE DIAGNOSIS BY

REGION OF THE SPINE, 2008 (%)

TABLE 39 U.S. AGE DISTRIBUTION FOR INPATIENTS DIAGNOSED

WITH DEGENERATION OF THE INTERVERTEBRAL DISCS, 2008 (%)

TABLE 40 U.S. TREND FOR INPATIENT DIAGNOSIS OF

DEGENERATION OF THE INTERVERTEBRAL DISC, THROUGH 2015

(%)

TABLE 41 U.S. DISTRIBUTION OF STENOSIS BY SPINAL REGION, 2008

(%)

TABLE 42 U.S. AGE DISTRIBUTION FOR INPATIENTS DIAGNOSED

WITH SPINAL STENOSIS, 2008 (%)

TABLE 43 U.S. TREND INPATIENT DIAGNOSIS OF SPINAL STENOSIS,

THROUGH 2015

TABLE 44 U.S. AGE DISTRIBUTION FOR INPATIENTS DIAGNOSED

WITH SPONDYLOLISTHESIS, 2008 (%)

TABLE 45 U.S. TREND IN INPATIENT DIAGNOSIS OF

SPONDYLOLISTHESIS, THROUGH 2015

TABLE 46 U.S. INPATIENTS WITH VERTEBRAL FRACTURE

DIAGNOSIS, 2008

TABLE 47 U.S. AND E.U. VERTEBRAL FRACTURES BY TYPE

TABLE 48 U.S. AGE DISTRIBUTION FOR INPATIENTS DIAGNOSED

WITH VERTEBRAL FRACTURES WITHOUT SPINAL CORD INJURY,

2008 (%)

TABLE 49 U.S. TREND FOR INPATIENT DIAGNOSIS OF VERTEBRAL

FRACTURE, THROUGH 2015 (%)

TABLE 50 U.S. FORECAST FOR INPATIENT DIAGNOSIS BY CODED

SPINAL CONDITION, THROUGH 2015 (THOUSANDS)

TABLE 51 U.S. SPINAL PROCEDURES BY VOLUME, THROUGH 2015

(THOUSANDS)

TABLE 52 U.S. COSTS FOR ALL SPINAL PROCEDURES, THROUGH

2015 ($ MILLIONS)

TABLE 53 U.S. DISTRIBUTION OF SPINAL SURGERY PROCEDURES

BY CATEGORY, 2008 (%)

TABLE 54 U.S. HIGHEST MEAN COSTS BY SPINAL SURGICAL

PROCEDURE, 2008 ($)

TABLE 55 PROCEDURAL ICD 9 CODES

TABLE 56 U.S. FORECAST VOLUME FOR DECOMPRESSION

PROCEDURES, THROUGH 2015

TABLE 57 U.S. FORECAST TOTAL COSTS FOR ALL DECOMPRESSION

PROCEDURES, THROUGH 2015 ($ MILLIONS)

TABLE 58 U.S. AGE DISTRIBUTION IN PATIENTS ADMITTED FOR

DISCECTOMIES, 2008 (%)

TABLE 59 U.S. REDUCTION IN MEAN LENGTH OF STAY FOR

DISCECTOMIES AS PRIMARY PROCEDURE, 2000 AND 2008 (DAYS)

TABLE 60 U.S. FORECAST VOLUME OF DISCECTOMIES, THROUGH

2015

TABLE 61 U.S. FORECAST MEAN COSTS PER DISCECTOMIES,

THROUGH 2015 ($)

TABLE 62 U.S. COMPARISON OF TOTAL COSTS FOR ALL

DISCECTOMIES, 2007-2015 ($ MILLIONS)

TABLE 63 U.S. AGE DISTRIBUTION IN PATIENTS ADMITTED FOR

LAMINOTOMY/FORAMINOTOMY, 2008 (%)

TABLE 64 U.S. FORECAST VOLUME OF

LAMINOTOMIES/FORAMINOTOMIES, THROUGH 2015

TABLE 65 U.S. FORECAST MEAN COSTS OF

LAMINOTOMIES/FORAMINOTOMIES, THROUGH 2015 ($)

TABLE 66 U.S. COMPARISON OF TOTAL COSTS FOR ALL

LAMINOTOMIES/FORAMINOTOMIES, 2007-2015 ($ MILLIONS)

TABLE 67 U.S. AGE DISTRIBUTION OF PATIENTS ADMITTED FOR

POST-LAMINECTOMY SYNDROME, 2008 (%)

TABLE 68 U.S. POST-LAMINECTOMY SYNDROME ADMISSIONS BY

SPINAL REGION, 2008 (%)

TABLE 69 U.S. AGE DISTRIBUTION IN PATIENTS ADMITTED FOR

CORPECTOMIES, 2008 (%)

TABLE 70 U.S. FORECAST VOLUME OF CORPECTOMIES, THROUGH

2015

TABLE 71 U.S. FORECAST OF MEAN COSTS FOR CORPECTOMIES,

THROUGH 2015 ($ THOUSANDS)

TABLE 72 U.S. COMPARISON OF TOTAL COSTS FOR ALL

CORPECTOMIES, 2007-2015 ($ MILLIONS)

TABLE 73 U.S. AGE DISTRIBUTION FOR FRACTION REPAIR

ADMISSIONS, 2008 (%)

TABLE 74 U.S. FORECAST FOR TOTAL VOLUME OF FRACTURE

REPAIR, THROUGH 2015

TABLE 75 U.S. FORECAST FOR TOTAL COSTS FOR ALL FRACTURE

REPAIR, THROUGH 2015 ($ MILLIONS)

TABLE 76 U.S. FORECAST VOLUME OF ADMISSIONS FOR

VERTEBROPLASTY, THROUGH 2015

TABLE 77 U.S. FORECAST OF MEAN COSTS FOR VERTEBROPLASTY,

THROUGH 2015 ($)

TABLE 78 U.S. COMPARISON OF TOTAL COSTS FOR ALL

VERTEBROPLASTY, 2007-2015 ($ MILLIONS)

TABLE 79 U.S. FORECAST VOLUME OF ADMISSIONS FOR

KYPHOPLASTY, THROUGH 2015

TABLE 80 U.S. FORECAST OF MEAN COSTS FOR KYPHOPLASTY,

THROUGH 2015 ($)

TABLE 81 U.S. COMPARISON OF TOTAL COSTS FOR ALL

KYPHOPLASTY, 2007-2015 ($ MILLIONS)

TABLE 82 U.S. FORECAST VOLUME OF ALL FUSIONS, THROUGH 2015

TABLE 83 U.S. FORECAST OF TOTAL COSTS FOR ALL FUSION

ADMISSIONS, THROUGH 2015 ($ MILLIONS)

TABLE 84 U.S. TOTAL FORECAST VOLUME OF FUSIONS BY LEVEL,

THROUGH 2015

TABLE 85 U.S. FORECAST OF MEAN FUSION COSTS BY LEVEL,

THROUGH 2015 ($)

TABLE 86 U.S. FORECAST OF TOTAL COSTS FOR ALL FUSIONS BY

LEVEL, THROUGH 2015 ($ MILLIONS)

TABLE 87 U.S. AGE DISTRIBUTION FOR ALL FUSIONS, 2000 AND 2008

(%)

TABLE 88 U.S. TRENDS FOR COMPLEX FUSIONS BY AGE, THROUGH

2008

TABLE 89 U.S. COMPARISON OF AGE DISTRIBUTION FOR COMPLEX

FUSION, 2006 AND 2008

TABLE 90 U.S. FORECAST OF FUSION VOLUME BY COMPLEXITY

LEVEL, THROUGH 2015

TABLE 91 U.S. DISTRIBUTION OF ALL FUSIONS BY SPINAL LEVEL,

2008

TABLE 92 U.S. FUSIONS BY APPROACH, 2008

TABLE 93 U.S. TOTAL VOLUME FOR IBFD AND FUSION, THROUGH

2008

TABLE 94 U.S. PROJECTED VOLUME FOR IBFD, THROUGH 2015

TABLE 95 U.S. PROJECTED MEAN COST OF IBFD, THROUGH 2015 ($)

TABLE 96 U.S. PROJECTED TOTAL COST FOR ALL IBFD, THROUGH

2015 ($ MILLIONS)

TABLE 97 U.S. AGE DISTRIBUTION FOR IBFD, 2008 (%)

TABLE 98 ANNUAL FREQUENCY OF USE OF BIOLOGICS

WORLDWIDE

TABLE 99 U.S. DISTRIBUTION OF REVISION SURGERIES BY LEVEL,

2008

TABLE 100 U.S. PROJECTED VOLUME OF REVISION SURGERIES BY

LEVEL, THROUGH 2015

TABLE 101 U.S. PROJECTED MEAN COST OF REVISION SURGERY BY

LEVEL, THROUGH 2015 ($)

TABLE 102 U.S. TOTAL COSTS FOR ALL REVISION SURGERIES BY

LEVEL, THROUGH 2015 ($ MILLIONS)

TABLE 103 U.S. TOTAL VOLUME OF POSTERIOR MOTION

PRESERVATION, 2008

TABLE 104 U.S. FORECAST OF TOTAL VOLUME INTERSPINOUS

PROCESS SPACERS, THROUGH 2015

TABLE 105 U.S. FORECAST OF MEAN COST INTERSPINOUS PROCESS

SPACERS, THROUGH 2015 ($)

TABLE 106 U.S. FORECAST OF TOTAL COST INTERSPINOUS PROCESS

SPACERS, THROUGH 2015 ($ THOUSANDS)

TABLE 107 U.S. TOTAL VOLUME OF POSTERIOR DYNAMIC

STABILIZATION, THROUGH 2008

TABLE 108 U.S. TOTAL DISC REPLACEMENT VOLUME BY SPINAL

LEVEL 2007 AND 2008

TABLE 109 U.S. VOLUME NUCLEUS REPLACEMENT, 2008

TABLE 110 GLOBAL FORECAST FOR SPINAL SURGICAL DEVICES,

THROUGH 2015 ($ MILLIONS)

TABLE 111 GLOBAL FORECAST FOR FUSION DEVICES, THROUGH

2015 ($ MILLIONS)

TABLE 112 GLOBAL FORECAST FOR FRACTURE REPAIR, THROUGH

2015 ($ MILLIONS)

TABLE 113 GLOBAL FORECAST FOR NON-FUSION DEVICES,

THROUGH 2015 ($ MILLIONS)

TABLE 114 GLOBAL FORECAST FOR ARTHROPLASTY, THROUGH 2015

($ MILLIONS)

TABLE 115 FREQUENTLY FDA-CLEARED SPINAL IMPLANTS, BY

DEVICE, 2000-2009

TABLE 116 510(K) FILINGS BY THE LARGEST SPINE COMPANIES,

2000-2009

TABLE 117 ACTIVE CLINICAL TRIALS FOR SPINAL SURGERY

DEVICES

TABLE 118 SPINE-RELATED PATENT SUB-CLASSIFICATIONS

TABLE 119 SPINAL PATENTS ISSUED AND APPLIED BY YEAR, 2001-

JUNE 1, 2010

TABLE 120 PATENTS ISSUED AND APPLIED BY SUBCLASS 2001-

JUNE 1, 2010

TABLE 121 MAJOR PLAYERS BY REVENUE, 2009 ($ MILLIONS)

TABLE 122 SPINAL SURGICAL DEVICE COMPANY BANKRUPTCIES,

2009

LIST OF FIGURES

SUMMARY FIGURE GLOBAL FORECAST SPINAL SURGICAL DEVICES

BY CATEGORY, 2008-2015 ($ MILLIONS)

FIGURE 1 COMPARISON OF TOTAL COSTS FOR ALL FUSION, 2007-

2015 ($ MILLIONS)

FIGURE 2 U.S. COMPARISON TOTAL COSTS FOR ALL IBFD, 2007-2015

($ MILLIONS)

FIGURE 3 U.S. COMPARISON OF TOTAL COSTS FOR ALL REVISION

SURGERIES, 2007-2015 ($ MILLIONS)