Spinal Fusion Pipeline by Stages of Development, Segments, Region, Regulatory Path and Key Companies

Pages: 324 Published: June 30, 2023 Report Code: GDME1569EPD

Spinal Fusion Market Overview

Spinal fusion procedures are mainly performed on the cervical and thoracolumbar regions. Spinal fusion is a surgical procedure that involves joining two vertebrae in the spine to form a single solid bone, with the involvement of certain devices, to relieve pain. Spinal fusion is performed by conventional and Minimally Invasive Surgery (MIS) methods. Conventional methods include all open surgical methods that are used for performing spinal procedures. Depending on the site of the incision (surgical approach), thoracolumbar fusion procedures are divided into anterior, posterior and lateral fusion procedures.

 The spinal fusion pipeline market research report provides comprehensive information about the spinal fusion pipeline products with a comparative analysis of the products at various stages of development and information about the clinical trials which are in progress.

Key Segment ·       Interbody devices

·       Pedicle screw systems

·       PEEK interbody devices

·       Spinal plating systems

Key Territories ·       The US

·       Europe

·       China

·       India

·       Australia

Key Regulatory Paths ·       510(k)

·       CE

·       NMPA

·       TGA

·       ICAC

Leading Companies ·       AMB Surgical II LLC

·       APTO Orthopaedics

·       Aurora Spine Corp

·       Biedermann Motech GmbH & Co KG

·       Bio2 Technologies Inc

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Spinal Fusion Pipeline Market Segments

Some of the key segments in the spinal fusion market are interbody devices, pedicle screw systems, PEEK interbody devices, and spinal plating systems among others. The interbody devices segment is leading in the market in 2023.

Spinal Fusion Pipeline Market Analysis, by Segments, 2023 (%)

Spinal Fusion Pipeline Market Analysis, by Segments, 2023 (%)

For more segments insights into the spinal fusion pipeline market, download a free report sample

Spinal Fusion Pipeline Market Segmentation by Territories

Some of the key territories in the spinal fusion market are the US, Europe, China, India, and Australia among others. As of June 2023, the US has the highest number of pipeline products.

Spinal Fusion Pipeline Market Analysis, by Territories, 2023 (%)

Spinal Fusion Pipeline Market Analysis, by Territories, 2023 (%)

or more territory insights into the spinal fusion pipeline market, download a free report sample

Spinal Fusion Pipeline Market Segmentation by Regulatory Paths

Some of the regulatory paths in the spinal fusion pipeline market are 510(k), NMPA, TGA, CE, and ICAC among others. As of June 2023, 510(k) is the most followed pathway for pipeline products.

Spinal Fusion Pipeline Market Analysis, by Regulatory Paths, 2023 (%)

Spinal Fusion Pipeline Market Analysis, by Regulatory Paths, 2023 (%)

For more regulatory path insights into the spinal fusion pipeline market, download a free report sample

Spinal Fusion Pipeline Market – Competitive Landscape

Some of the key companies in the spinal fusion pipeline market are AMB Surgical II LLC, APTO Orthopaedics, Aurora Spine Corp, Biedermann Motech GmbH & Co KG, and Bio2 Technologies Inc among others.

AMB Surgical II LLC: AMB Surgical II LLC, is a developer of FLYTE automated growing rod technology to reduce anxiety and trauma from juvenile and adolescent surgeries. The company is headquartered in United States.

Segments Covered in the Report

Spinal Fusion Pipeline Market Segments Outlook

  • Interbody devices
  • Pedicle screw systems
  • PEEK interbody devices
  • Spinal plating systems

Spinal Fusion Pipeline Market Territories Outlook

  • The US
  • Europe
  • China
  • India
  • Australia

Spinal Fusion Pipeline Market Regulatory Paths Outlook

  • 510(k)
  • CE
  • NMPA
  • TGA
  • ICAC

Scope

  • Extensive coverage of the spinal fusion under development
  • Reviews details of major pipeline products which include, product description, licensing and collaboration details, and other developmental activities
  • Reviews the major players involved in the development of spinal fusion and list all their pipeline projects
  • The coverage of pipeline products based on various stages of development ranging from Early Development to Approved / Issued stage
  • The report provides key clinical trial data of ongoing trials specific to pipeline products
  • Recent developments in the segment/industry

Reasons to Buy

The report enables you to:

  • Formulate significant competitor information, analysis, and insights to improve R&D strategies
  • Identify emerging players with potentially strong product portfolios and create effective counter strategies to gain a competitive advantage
  • Identify and understand important and diverse types of spinal fusion under development
  • Develop market-entry and market expansion strategies
  • Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline
  • In-depth analysis of the product’s current stage of development, territory, and estimated launch date

Key Players

3D Systems Inc
Acuitive Technologies Inc
Allegra Orthopaedics Ltd
ALM Ortho Inc
Alphatec Holdings Inc
AMB Surgical II LLC
APTO Orthopaedics
Aurora Spine Corp
Biedermann Motech GmbH & Co KG
Bio2 Technologies Inc
Bioretec Ltd
Butterfly Spine, LLC
Camber Spine Technologies LLC
Choice Spine LLC
Clariance Inc
Clariance SAS
Corelink LLC
Cortical Concepts (Inactive)
CTL Amedica Corp
Cutting Edge Spine LLC
DePuy Synthes Inc
DSM Biomedical BV
DSM Dyneema BV
Eden Spine LLC
EDGe Surgical Inc
Eminent Spine LLC
ErgoSpine
Evoke Medical LLC
FacetMed Ltd
Farmove Medical
Fuse Medical Inc
GS Medical LLC
H. Lee Moffitt Cancer Center & Research Institute Inc
HAPPE Spine LLC
HD LifeSciences LLC
Implanet SA
Innospina LLC
Innov'spine
Intelligent Implant Systems LLC
Intelligent Implants
Jemo Spine, LLC.
joimax GmbH
LESspine LLC
Lifespans Ltd
Mayo Clinic
Medicrea Group
Medtronic Plc
Medyssey Co Ltd
Mekanika Inc
Mercy Health Research
Mesoblast Ltd
MI4 Spine, LLC
Michigan State University
MicroPort Scientific Corp
N8 Medical LLC
Nanovis Inc
Nasseo, Inc.
NEOS Surgery SL
Neumedix Surgical Pty Ltd
Nexilis AG
Nexxt Spine LLC
Novadip Biosciences SA
Novum Medical Products, Inc.
Nutech Medical Inc
NuVasive Inc
Orchid Orthopedic Solutions LLC
Orthobond
OsteoGeneX Inc
OsteoVantage Inc
Ozop Surgical Corp (Inactive)
Pharmaco-Kinesis Corp
Precision Spine Inc
Providence Medical Technology Inc
RegeneEx Ltd.
Resoimplant GmbH (Inactive)
RevBio Inc
ReVivo Medical, LLC
Sail Fusion LLC
SANUWAVE Health Inc
SeaSpine, Inc.
Signus Medical LLC
SINTX Technologies Inc
Spinal Balance Inc.
Spinal Elements Inc
Spinal Resources Inc
Spinal Simplicity LLC
SpinalVu Inc (Inactive)
Spine Wave Inc
SpineGuard SA
SpineSmith Holdings LLC
SpineVision SA
Sree Chitra Tirunal Institute for Medical Sciences & Technology
Stryker Corp
Taragenyx Ltd (Inactive)
Theradaptive Inc
Tissue Regeneration Systems, Inc.
TranS1 Inc
TruSpine Technologies Plc
University of Colorado
University of Colorado Anschutz Medical Campus
University of Pittsburgh
University of South Florida
University of Toledo
University of Utah
University of Virginia
VersaSpine LLC
Vertech Inc
Verticor (Inactive)
VGI Medical LLC
White Light Medical
Xtant Medical Holdings Inc
Xtremity & Spinal Solutions Ltd
Yunyi (Beijing) Medical Device Co Ltd
Zyga Technology Inc
ZygoFix Ltd

Table of Contents

|1 Table of Contents 3

|1.1 List of Tables 10

|1.2 List of Figures 20

2 Introduction 21

2.1 Spinal Fusion Overview 21

3 Products under Development 22

3.1 Spinal Fusion – Pipeline Products by Stage of Development 22

3.2 Spinal Fusion – Pipeline Products by Segment 23

3.3 Spinal Fusion – Pipeline Products by Territory 24

3.4 Spinal Fusion – Pipeline Products by Regulatory Path 25

3.5 Spinal Fusion – Pipeline Products by Estimated Approval Date 26

3.6 Spinal Fusion – Ongoing Clinical Trials 27

4 Spinal Fusion – Pipeline Products under Development by Companies 28

4.1 Spinal Fusion Companies – Pipeline Products by Stage of Development 28

4.2 Spinal Fusion – Pipeline Products by Stage of Development 33

5 Spinal Fusion Companies and Product Overview 38

5.1 3D Systems Inc Company Overview 38

5.1.1 3D Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 38

5.2 Acuitive Technologies Inc Company Overview 39

5.2.1 Acuitive Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 39

5.3 Allegra Orthopaedics Ltd Company Overview 40

5.3.1 Allegra Orthopaedics Ltd Pipeline Products & Ongoing Clinical Trials Overview 40

5.4 ALM Ortho Inc Company Overview 41

5.4.1 ALM Ortho Inc Pipeline Products & Ongoing Clinical Trials Overview 41

5.5 Alphatec Holdings Inc Company Overview 43

5.5.1 Alphatec Holdings Inc Pipeline Products & Ongoing Clinical Trials Overview 43

5.6 AMB Surgical II LLC Company Overview 49

5.6.1 AMB Surgical II LLC Pipeline Products & Ongoing Clinical Trials Overview 49

5.7 APTO Orthopaedics Company Overview 50

5.7.1 APTO Orthopaedics Pipeline Products & Ongoing Clinical Trials Overview 50

5.8 Aurora Spine Corp Company Overview 51

5.8.1 Aurora Spine Corp Pipeline Products & Ongoing Clinical Trials Overview 51

5.9 Biedermann Motech GmbH & Co KG Company Overview 54

5.9.1 Biedermann Motech GmbH & Co KG Pipeline Products & Ongoing Clinical Trials Overview 54

5.10 Bio2 Technologies Inc Company Overview 55

5.10.1 Bio2 Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 55

5.11 Bioretec Ltd Company Overview 57

5.11.1 Bioretec Ltd Pipeline Products & Ongoing Clinical Trials Overview 57

5.12 Butterfly Spine, LLC Company Overview 58

5.12.1 Butterfly Spine, LLC Pipeline Products & Ongoing Clinical Trials Overview 58

5.13 Camber Spine Technologies LLC Company Overview 59

5.13.1 Camber Spine Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 59

5.14 Choice Spine LLC Company Overview 64

5.14.1 Choice Spine LLC Pipeline Products & Ongoing Clinical Trials Overview 64

5.15 Clariance Inc Company Overview 66

5.15.1 Clariance Inc Pipeline Products & Ongoing Clinical Trials Overview 66

5.16 Clariance SAS Company Overview 67

5.16.1 Clariance SAS Pipeline Products & Ongoing Clinical Trials Overview 67

5.17 Corelink LLC Company Overview 70

5.17.1 Corelink LLC Pipeline Products & Ongoing Clinical Trials Overview 70

5.18 Cortical Concepts (Inactive) Company Overview 73

5.18.1 Cortical Concepts (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 73

5.19 CTL Amedica Corp Company Overview 74

5.19.1 CTL Amedica Corp Pipeline Products & Ongoing Clinical Trials Overview 74

5.20 Cutting Edge Spine LLC Company Overview 77

5.20.1 Cutting Edge Spine LLC Pipeline Products & Ongoing Clinical Trials Overview 77

5.21 DePuy Synthes Inc Company Overview 79

5.21.1 DePuy Synthes Inc Pipeline Products & Ongoing Clinical Trials Overview 79

5.22 DSM Biomedical BV Company Overview 81

5.22.1 DSM Biomedical BV Pipeline Products & Ongoing Clinical Trials Overview 81

5.23 DSM Dyneema BV Company Overview 84

5.23.1 DSM Dyneema BV Pipeline Products & Ongoing Clinical Trials Overview 84

5.24 Eden Spine LLC Company Overview 85

5.24.1 Eden Spine LLC Pipeline Products & Ongoing Clinical Trials Overview 85

5.25 EDGe Surgical Inc Company Overview 86

5.25.1 EDGe Surgical Inc Pipeline Products & Ongoing Clinical Trials Overview 86

5.26 Eminent Spine LLC Company Overview 87

5.26.1 Eminent Spine LLC Pipeline Products & Ongoing Clinical Trials Overview 87

5.27 ErgoSpine Company Overview 89

5.27.1 ErgoSpine Pipeline Products & Ongoing Clinical Trials Overview 89

5.28 Evoke Medical LLC Company Overview 90

5.28.1 Evoke Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 90

5.29 FacetMed Ltd Company Overview 91

5.29.1 FacetMed Ltd Pipeline Products & Ongoing Clinical Trials Overview 91

5.30 Farmove Medical Company Overview 93

5.30.1 Farmove Medical Pipeline Products & Ongoing Clinical Trials Overview 93

5.31 Fuse Medical Inc Company Overview 94

5.31.1 Fuse Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 94

5.32 GS Medical LLC Company Overview 96

5.32.1 GS Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 96

5.33 H. Lee Moffitt Cancer Center & Research Institute Inc Company Overview 98

5.33.1 H. Lee Moffitt Cancer Center & Research Institute Inc Pipeline Products & Ongoing Clinical Trials Overview 98

5.34 HAPPE Spine LLC Company Overview 99

5.34.1 HAPPE Spine LLC Pipeline Products & Ongoing Clinical Trials Overview 99

5.35 HD LifeSciences LLC Company Overview 102

5.35.1 HD LifeSciences LLC Pipeline Products & Ongoing Clinical Trials Overview 102

5.36 Implanet SA Company Overview 104

5.36.1 Implanet SA Pipeline Products & Ongoing Clinical Trials Overview 104

5.37 Innospina LLC Company Overview 110

5.37.1 Innospina LLC Pipeline Products & Ongoing Clinical Trials Overview 110

5.38 Innov’spine Company Overview 111

5.38.1 Innov’spine Pipeline Products & Ongoing Clinical Trials Overview 111

5.39 Intelligent Implant Systems LLC Company Overview 112

5.39.1 Intelligent Implant Systems LLC Pipeline Products & Ongoing Clinical Trials Overview 112

5.40 Intelligent Implants Company Overview 114

5.40.1 Intelligent Implants Pipeline Products & Ongoing Clinical Trials Overview 114

5.41 Jemo Spine, LLC. Company Overview 115

5.41.1 Jemo Spine, LLC. Pipeline Products & Ongoing Clinical Trials Overview 115

5.42 joimax GmbH Company Overview 117

5.42.1 joimax GmbH Pipeline Products & Ongoing Clinical Trials Overview 117

5.43 LESspine LLC Company Overview 118

5.43.1 LESspine LLC Pipeline Products & Ongoing Clinical Trials Overview 118

5.44 Lifespans Ltd Company Overview 122

5.44.1 Lifespans Ltd Pipeline Products & Ongoing Clinical Trials Overview 122

5.45 Mayo Clinic Company Overview 123

5.45.1 Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 123

5.46 Medicrea Group Company Overview 124

5.46.1 Medicrea Group Pipeline Products & Ongoing Clinical Trials Overview 124

5.47 Medtronic Plc Company Overview 125

5.47.1 Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 125

5.48 Medyssey Co Ltd Company Overview 128

5.48.1 Medyssey Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 128

5.49 Mekanika Inc Company Overview 129

5.49.1 Mekanika Inc Pipeline Products & Ongoing Clinical Trials Overview 129

5.50 Mercy Health Research Company Overview 130

5.50.1 Mercy Health Research Pipeline Products & Ongoing Clinical Trials Overview 130

5.51 Mesoblast Ltd Company Overview 131

5.51.1 Mesoblast Ltd Pipeline Products & Ongoing Clinical Trials Overview 131

5.52 MI4 Spine, LLC Company Overview 132

5.52.1 MI4 Spine, LLC Pipeline Products & Ongoing Clinical Trials Overview 132

5.53 Michigan State University Company Overview 135

5.53.1 Michigan State University Pipeline Products & Ongoing Clinical Trials Overview 135

5.54 MicroPort Scientific Corp Company Overview 136

5.54.1 MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 136

5.55 N8 Medical LLC Company Overview 138

5.55.1 N8 Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 138

5.56 Nanovis Inc Company Overview 139

5.56.1 Nanovis Inc Pipeline Products & Ongoing Clinical Trials Overview 139

5.57 Nasseo, Inc. Company Overview 140

5.57.1 Nasseo, Inc. Pipeline Products & Ongoing Clinical Trials Overview 140

5.58 NEOS Surgery SL Company Overview 141

5.58.1 NEOS Surgery SL Pipeline Products & Ongoing Clinical Trials Overview 141

5.59 Neumedix Surgical Pty Ltd Company Overview 142

5.59.1 Neumedix Surgical Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 142

5.60 Nexilis AG Company Overview 143

5.60.1 Nexilis AG Pipeline Products & Ongoing Clinical Trials Overview 143

5.61 Nexxt Spine LLC Company Overview 146

5.61.1 Nexxt Spine LLC Pipeline Products & Ongoing Clinical Trials Overview 146

5.62 Novadip Biosciences SA Company Overview 148

5.62.1 Novadip Biosciences SA Pipeline Products & Ongoing Clinical Trials Overview 148

5.63 Novum Medical Products, Inc. Company Overview 149

5.63.1 Novum Medical Products, Inc. Pipeline Products & Ongoing Clinical Trials Overview 149

5.64 Nutech Medical Inc Company Overview 151

5.64.1 Nutech Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 151

5.65 NuVasive Inc Company Overview 152

5.65.1 NuVasive Inc Pipeline Products & Ongoing Clinical Trials Overview 152

5.66 Orchid Orthopedic Solutions LLC Company Overview 154

5.66.1 Orchid Orthopedic Solutions LLC Pipeline Products & Ongoing Clinical Trials Overview 154

5.67 Orthobond Company Overview 155

5.67.1 Orthobond Pipeline Products & Ongoing Clinical Trials Overview 155

5.68 OsteoGeneX Inc Company Overview 156

5.68.1 OsteoGeneX Inc Pipeline Products & Ongoing Clinical Trials Overview 156

5.69 OsteoVantage Inc Company Overview 157

5.69.1 OsteoVantage Inc Pipeline Products & Ongoing Clinical Trials Overview 157

5.70 Ozop Surgical Corp (Inactive) Company Overview 158

5.70.1 Ozop Surgical Corp (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 158

5.71 Pharmaco-Kinesis Corp Company Overview 159

5.71.1 Pharmaco-Kinesis Corp Pipeline Products & Ongoing Clinical Trials Overview 159

5.72 Precision Spine Inc Company Overview 160

5.72.1 Precision Spine Inc Pipeline Products & Ongoing Clinical Trials Overview 160

5.73 Providence Medical Technology Inc Company Overview 161

5.73.1 Providence Medical Technology Inc Pipeline Products & Ongoing Clinical Trials Overview 161

5.74 RegeneEx Ltd. Company Overview 164

5.74.1 RegeneEx Ltd. Pipeline Products & Ongoing Clinical Trials Overview 164

5.75 Resoimplant GmbH (Inactive) Company Overview 165

5.75.1 Resoimplant GmbH (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 165

5.76 RevBio Inc Company Overview 166

5.76.1 RevBio Inc Pipeline Products & Ongoing Clinical Trials Overview 166

5.77 ReVivo Medical, LLC Company Overview 167

5.77.1 ReVivo Medical, LLC Pipeline Products & Ongoing Clinical Trials Overview 167

5.78 Sail Fusion LLC Company Overview 168

5.78.1 Sail Fusion LLC Pipeline Products & Ongoing Clinical Trials Overview 168

5.79 SANUWAVE Health Inc Company Overview 169

5.79.1 SANUWAVE Health Inc Pipeline Products & Ongoing Clinical Trials Overview 169

5.80 SeaSpine, Inc. Company Overview 170

5.80.1 SeaSpine, Inc. Pipeline Products & Ongoing Clinical Trials Overview 170

5.81 Signus Medical LLC Company Overview 175

5.81.1 Signus Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 175

5.82 SINTX Technologies Inc Company Overview 176

5.82.1 SINTX Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 176

5.83 Spinal Balance Inc. Company Overview 178

5.83.1 Spinal Balance Inc. Pipeline Products & Ongoing Clinical Trials Overview 178

5.84 Spinal Elements Inc Company Overview 179

5.84.1 Spinal Elements Inc Pipeline Products & Ongoing Clinical Trials Overview 179

5.85 Spinal Resources Inc Company Overview 180

5.85.1 Spinal Resources Inc Pipeline Products & Ongoing Clinical Trials Overview 180

5.86 Spinal Simplicity LLC Company Overview 183

5.86.1 Spinal Simplicity LLC Pipeline Products & Ongoing Clinical Trials Overview 183

5.87 SpinalVu Inc (Inactive) Company Overview 184

5.87.1 SpinalVu Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 184

5.88 Spine Wave Inc Company Overview 186

5.88.1 Spine Wave Inc Pipeline Products & Ongoing Clinical Trials Overview 186

5.89 SpineGuard SA Company Overview 187

5.89.1 SpineGuard SA Pipeline Products & Ongoing Clinical Trials Overview 187

5.90 SpineSmith Holdings LLC Company Overview 188

5.90.1 SpineSmith Holdings LLC Pipeline Products & Ongoing Clinical Trials Overview 188

5.91 SpineVision SA Company Overview 191

5.91.1 SpineVision SA Pipeline Products & Ongoing Clinical Trials Overview 191

5.92 Sree Chitra Tirunal Institute for Medical Sciences & Technology Company Overview 192

5.92.1 Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 192

5.93 Stryker Corp Company Overview 193

5.93.1 Stryker Corp Pipeline Products & Ongoing Clinical Trials Overview 193

5.94 Taragenyx Ltd (Inactive) Company Overview 196

5.94.1 Taragenyx Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 196

5.95 Theradaptive Inc Company Overview 197

5.95.1 Theradaptive Inc Pipeline Products & Ongoing Clinical Trials Overview 197

5.96 Tissue Regeneration Systems, Inc. Company Overview 198

5.96.1 Tissue Regeneration Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 198

5.97 TranS1 Inc Company Overview 199

5.97.1 TranS1 Inc Pipeline Products & Ongoing Clinical Trials Overview 199

5.98 TruSpine Technologies Plc Company Overview 200

5.98.1 TruSpine Technologies Plc Pipeline Products & Ongoing Clinical Trials Overview 200

5.99 University of Colorado Company Overview 203

5.99.1 University of Colorado Pipeline Products & Ongoing Clinical Trials Overview 203

5.100 University of Colorado Anschutz Medical Campus Company Overview 204

5.100.1 University of Colorado Anschutz Medical Campus Pipeline Products & Ongoing Clinical Trials Overview 204

5.101 University of Pittsburgh Company Overview 205

5.101.1 University of Pittsburgh Pipeline Products & Ongoing Clinical Trials Overview 205

5.102 University of South Florida Company Overview 206

5.102.1 University of South Florida Pipeline Products & Ongoing Clinical Trials Overview 206

5.103 University of Toledo Company Overview 210

5.103.1 University of Toledo Pipeline Products & Ongoing Clinical Trials Overview 210

5.104 University of Utah Company Overview 216

5.104.1 University of Utah Pipeline Products & Ongoing Clinical Trials Overview 216

5.105 University of Virginia Company Overview 217

5.105.1 University of Virginia Pipeline Products & Ongoing Clinical Trials Overview 217

5.106 VersaSpine LLC Company Overview 218

5.106.1 VersaSpine LLC Pipeline Products & Ongoing Clinical Trials Overview 218

5.107 Vertech Inc Company Overview 219

5.107.1 Vertech Inc Pipeline Products & Ongoing Clinical Trials Overview 219

5.108 Verticor (Inactive) Company Overview 220

5.108.1 Verticor (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 220

5.109 VGI Medical LLC Company Overview 221

5.109.1 VGI Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 221

5.110 White Light Medical Company Overview 222

5.110.1 White Light Medical Pipeline Products & Ongoing Clinical Trials Overview 222

5.111 Xtant Medical Holdings Inc Company Overview 223

5.111.1 Xtant Medical Holdings Inc Pipeline Products & Ongoing Clinical Trials Overview 223

5.112 Xtremity & Spinal Solutions Ltd Company Overview 224

5.112.1 Xtremity & Spinal Solutions Ltd Pipeline Products & Ongoing Clinical Trials Overview 224

5.113 Yunyi (Beijing) Medical Device Co Ltd Company Overview 226

5.113.1 Yunyi (Beijing) Medical Device Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 226

5.114 Zyga Technology Inc Company Overview 227

5.114.1 Zyga Technology Inc Pipeline Products & Ongoing Clinical Trials Overview 227

5.115 ZygoFix Ltd Company Overview 228

5.115.1 ZygoFix Ltd Pipeline Products & Ongoing Clinical Trials Overview 228

6 Spinal Fusion – Recent Developments 234

6.1 Jun 14, 2023: SpineGuard Announces Second Call of the Annual Shareholders’ Meeting on June 29, 2023 234

6.2 May 26, 2023: Bioretec announces Resolutions of annual general meeting 234

6.3 May 23, 2023: Aurora Spine schedules release of Q1 fiscal year 2023 financial results and conference call 236

6.4 May 22, 2023: BioSenic provides Q1 2023 business update 236

6.5 May 18, 2023: Centinel Spine announces record worldwide motion preservation revenue in first quarter 2023 238

6.6 May 16, 2023: Former U.S. White House Surgeon and FDA Medical Officer joins Bioretec team 239

6.7 May 11, 2023: Medtronic to announce financial results for its fourth quarter and full fiscal year 2023 239

6.8 May 05, 2023: Bioretec Notice of Annual General Meeting 239

6.9 May 04, 2023: NuVasive announces conference call and webcast of Q1 2023 results 244

6.10 Apr 27, 2023: BioSenic Announces 2022 Full Year Results 244

6.11 Apr 27, 2023: Xtant Medical to issue First Quarter 2023 financial results on May 4, 2023 247

6.12 Apr 26, 2023: Aurora Spine schedules release of Q4 and fiscal year 2022 financial results and conference call 248

6.13 Apr 26, 2023: Orthofix Medical schedules Q1 earnings release and conference call for May 9, 2023 248

6.14 Apr 26, 2023: Smith & Nephew announces Q1 2023 trading update 248

6.15 Apr 13, 2023: SpineGuard Announces Its Full-year 2022 Financial Results and Its First Quarter 2023 Sales 251

6.16 Apr 13, 2023: Safe group announces revenues of €1.5 million in Q1 2023 254

6.17 Apr 12, 2023: Medtronic has a layoff in California 255

6.18 Apr 06, 2023: Smith & Nephew Notice of First Quarter 2023 Trading Report 255

6.19 Apr 03, 2023: BioSenic appoints Lieven Huysse MD as Chief Medical Officer 255

6.20 Mar 31, 2023: OrthoPediatrics Leading Sponsorship at Annual EPOS Meeting 256

6.21 Mar 28, 2023: Stryker announces Annual Meeting of Shareholders 257

6.22 Mar 16, 2023: Surgalign to Host its 2023 Annual Meeting of Shareholders on June 1, 2023 257

6.23 Mar 16, 2023: Medtronic joins in $25M funding round for home monitoring company 257

6.24 Mar 08, 2023: Geisinger Health Plan, Medacta announce first spinal fusion lifetime guarantee 257

6.25 Mar 07, 2023: Xtant Medical Announces Fourth Quarter and Full Year 2022 Financial Results 258

6.26 Mar 06, 2023: Smith & Nephew Announces Annual Financial Report 2022 259

6.27 Mar 06, 2023: Smith & Nephew Notice of 2023 Annual General Meeting 259

6.28 Feb 21, 2023: Smith & Nephew Announces Fourth Quarter and Full Year 2022 Results 259

6.29 Feb 21, 2023: Orthofix Medical Schedules Fourth Quarter Earnings Release and Conference Call for March 6, 2023 261

6.30 Feb 17, 2023: Bioretec Announces financial statements bulletin 2022 261

6.31 Feb 14, 2023: Spineway Reports Full Year 2022 Earnings 263

6.32 Feb 09, 2023: Spinal Elements Appoints Ron Lloyd as President and Chief Executive Officer 263

6.33 Feb 09, 2023: Spineway announces 2022 annual results 263

6.34 Feb 03, 2023: Medacta Group reports a robust

20.4% revenue growth in 2022 reaching

437.1 M€ 264

6.35 Jan 27, 2023: BioSenic appoints Yves Sagot as Independent Director 265

6.36 Jan 25, 2023: Tyber Medical Names James Abraham and Damien Sibilla to Executive Leadership Team 266

6.37 Jan 24, 2023: IMPLANET Reports 2022 Annual Revenue of €8.0 Million, up 31% 266

6.38 Jan 18, 2023: BioSenic appoints Dr Carole Nicco as Chief Scientific Officer 268

6.39 Jan 09, 2023: Orthofix Medical Announces Preliminary SeaSpine and Orthofix 2022 Fourth Quarter and Full-Year Net Sales Results 268

6.40 Jan 09, 2023: ATEC Announces Select Preliminary Financial 2022 Results, 2023 Guidance and Closing of Flexible, Non-Dilutive Debt Facility 271

6.41 Jan 09, 2023: SpineGuard Reports a +37% Increase in Q4 2022 Revenue 272

6.42 Dec 20, 2022: Bioretec’s financial information and Annual General Meeting in 2023 273

6.43 Dec 19, 2022: Spineart and eCential Robotics annouce a partnership to co-develop spine surgery applications and co-market the eCential Robotics’ open robotic surgery platform 273

6.44 Dec 02, 2022: BioSenic appoints Michel Wurm, M.D. as Chief Medical Officer 274

6.45 Nov 23, 2022: Medtronic Reports Quarterly Earnings 275

6.46 Nov 22, 2022: Medtronic reports second quarter fiscal 2023 financial results 275

6.47 Nov 22, 2022: Mesoblast Reports Financial Results and Operational Highlights for the Period Ended September 30, 2022 281

6.48 Nov 21, 2022: Mesoblast Financial Results and Corporate Update Webcast 283

6.49 Nov 21, 2022: Aurora Spine Announces Third Quarter Fiscal 2022 Financial Results 283

6.50 Nov 21, 2022: Hogan Lovells advises Stumpf Group on minority investment by funds managed by BDT Capital Partners in Exyte Group 284

6.51 Nov 15, 2022: Medtronic Set to Announce Earnings on Tuesday 285

6.52 Nov 10, 2022: Surgalign aims to slash $30M from 2023 spending with planned layoffs 285

6.53 Nov 09, 2022: Safe announces the convocation of an extraordinary general meeting of the Company to be held on December 16, 2022 285

6.54 Nov 07, 2022: NuVasive launches tube system and excavation micro for posterior spine surgery 285

6.55 Oct 30, 2022: Mesoblast Operational and Financial Highlights for Quarter Ended September 30, 2022 286

6.56 Oct 27, 2022: Xtant Medical to Issue Third Quarter 2022 Financial Results on November 3, 2022 286

6.57 Oct 25, 2022: Orthofix Medical Schedules Third Quarter Earnings Release and Conference Call for November 3, 2022 287

6.58 Oct 19, 2022: Allosource Announces Dean Elliott as New President and CEO 287

6.59 Oct 12, 2022: Aurora Spine Corporation to Attend the North American Spine Society Annual Meeting 287

6.60 Oct 11, 2022: Kuros Biosciences to present positive clinical data for MagnetOs at NASS 2022 Annual Meeting 288

6.61 Oct 11, 2022: Orthofix Announces Preliminary Third Quarter and Year-To-Date 2022 Net Sales Results 289

6.62 Oct 10, 2022: ATEC Announces Select Preliminary Third Quarter 2022 Financial Results and Raises Guidance 291

6.63 Oct 06, 2022: Safe group announces its first semester financial results and Q3 sales 291

6.64 Oct 06, 2022: Integra LifeSciences appoints Harvinder Singh as Executive Vice President, President Of Co.”s International Business 293

6.65 Oct 06, 2022: Integra LifeSciences Announces Key Executive Appointment 293

6.66 Oct 04, 2022: Exactech Names New Chief Financial Officer 294

6.67 Sep 20, 2022: Implanet Publishes its 2022 Half-year Results 294

6.68 Sep 14, 2022: Orthofix Medical Announces Participation in Upcoming Sidoti Virtual Investor Conference 296

6.69 Sep 12, 2022: NuVasive to Participate as Double Diamond Sponsor at Scoliosis Research Society Annual Meeting 296

6.70 Sep 07, 2022: Bone Therapeutics reports half year 2022 results 297

6.71 Sep 07, 2022: Medtronic to appear at September investor conferences 298

6.72 Aug 30, 2022: ATEC to Participate in Upcoming Investor Conferences 299

6.73 Aug 30, 2022: Mesoblast Reports Financial Results and Operational Highlights for Fiscal Year Ended June 30, 2022 299

6.74 Aug 23, 2022: New Chief Financial Officer Appointment Strengthens Spineology’s Executive Leadership Team 302

6.75 Aug 23, 2022: Medtronic reports first quarter fiscal 2023 financial results 302

6.76 Aug 23, 2022: Medtronic Announces Quarterly Earnings Results 305

6.77 Aug 12, 2022: Sintx Technologies Reports Earnings Results for the Second Quarter and Six Months Ended June 30, 2022 308

6.78 Aug 09, 2022: Mesoblast shares slide on $65m capital raise announcement 309

6.79 Aug 09, 2022: Kuros Biosciences reports results for the first six months of 2022 309

6.80 Aug 04, 2022: ATEC Reports Second Quarter 2022 Financial Results and Increases Full-Year Revenue Guidance 310

6.81 Aug 03, 2022: Orthopediatrics Reports Second Quarter 2022 Financial Results and Increases 2022 Revenue Guidance 310

6.82 Aug 02, 2022: Allosource Announces President and CEO Retirement 314

6.83 Aug 02, 2022: Zimmer Biomet Announces Second Quarter 2022 Financial Results 314

6.84 Jul 29, 2022: Medacta Group reports

19.0% growth of half-year revenue 315

6.85 Jul 28, 2022: Smith+Nephew Second Quarter and First Half 2022 Results 315

6.86 Jul 28, 2022: Xtant Medical to Issue Second Quarter 2022 Financial Results on August 4, 2022 316

6.87 Jul 26, 2022: ATEC to Participate in Upcoming Investor Conferences 317

6.88 Jul 21, 2022: ATEC to Report Second Quarter 2022 Financial Results on August 4 2022 317

6.89 Jul 12, 2022: SpineGuard Posts 20% Revenue Growth in Q2-2022 317

6.90 Jul 12, 2022: Aspire & USF Pass $10M in ticket & donation revenue 318

6.91 Jul 11, 2022: Implanet Reports Its Revenue for Q2 2022, Up 33% 319

6.92 Jul 09, 2022: Shanghai Sanyou Medical Co. Announces appointment of senior management personnel and securities affairs representatives 320

7 Appendix 321

7.1 Methodology 321

7.2 About GlobalData 324

7.3 Contact Us 324

7.4 Disclaimer 324

List of Tables

Spinal Fusion – Pipeline Products by Stage of Development 22

Spinal Fusion – Pipeline Products by Segment 23

Spinal Fusion – Pipeline Products by Territory 24

Spinal Fusion – Pipeline Products by Regulatory Path 25

Spinal Fusion – Pipeline Products by Estimated Approval Date 26

Spinal Fusion – Ongoing Clinical Trials 27

Spinal Fusion Companies – Pipeline Products by Stage of Development 28

Spinal Fusion – Pipeline Products by Stage of Development 33

3D Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 38

Spinal Cage – Product Status 38

Spinal Cage – Product Description 38

Acuitive Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 39

Citrefuse – Product Status 39

Citrefuse – Product Description 39

Allegra Orthopaedics Ltd Pipeline Products & Ongoing Clinical Trials Overview 40

Sr-HT-Gahnite Spinal Cage Device – Product Status 40

Sr-HT-Gahnite Spinal Cage Device – Product Description 40

ALM Ortho Inc Pipeline Products & Ongoing Clinical Trials Overview 41

Lateral Intervertebral Fusion Cage – Product Status 41

Lateral Intervertebral Fusion Cage – Product Description 41

SI Joint Fusion Device – Product Status 42

SI Joint Fusion Device – Product Description 42

Alphatec Holdings Inc Pipeline Products & Ongoing Clinical Trials Overview 43

BioScorp – Product Status 43

BioScorp – Product Description 44

Helifuse – Product Status 44

Helifuse – Product Description 44

Lateral Interbody with Expandable Cage – Product Status 45

Lateral Interbody with Expandable Cage – Product Description 45

OsseoFix Next Generation Implant – Product Status 45

OsseoFix Next Generation Implant – Product Description 46

OsseoSleeve – Product Status 46

OsseoSleeve – Product Description 46

PCB – Product Status 47

PCB – Product Description 47

Samarys RF – Product Status 47

Samarys RF – Product Description 48

AMB Surgical II LLC Pipeline Products & Ongoing Clinical Trials Overview 49

FLYTE SPINE – Product Status 49

FLYTE SPINE – Product Description 49

APTO Orthopaedics Pipeline Products & Ongoing Clinical Trials Overview 50

Pediatric Spinal Fixation System – Product Status 50

Pediatric Spinal Fixation System – Product Description 50

Aurora Spine Corp Pipeline Products & Ongoing Clinical Trials Overview 51

Restore Kyphoplasty System – Product Status 51

Restore Kyphoplasty System – Product Description 51

SiLO-FX Fusion System – Product Status 52

SiLO-FX Fusion System – Product Description 52

VOX 2.0 – Product Status 52

VOX 2.0 – Product Description 53

Biedermann Motech GmbH & Co KG Pipeline Products & Ongoing Clinical Trials Overview 54

Mesh – Product Status 54

Mesh – Product Description 54

Bio2 Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 55

Vitrium – Cervical Interbody Fusion Device – Product Status 55

Vitrium – Cervical Interbody Fusion Device – Product Description 55

Vitrium – Lumbar Interbody Fusion Device – Product Status 56

Vitrium – Lumbar Interbody Fusion Device – Product Description 56

Bioretec Ltd Pipeline Products & Ongoing Clinical Trials Overview 57

Spinal Plate – Spinal Osteosynthesis – Product Status 57

Spinal Plate – Spinal Osteosynthesis – Product Description 57

Butterfly Spine, LLC Pipeline Products & Ongoing Clinical Trials Overview 58

Interspinous Dynamic Fusion Device – Product Status 58

Interspinous Dynamic Fusion Device – Product Description 58

Camber Spine Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 59

SPIRA – Expandable Transforaminal Lumbar Interbody – Product Status 59

SPIRA – Expandable Transforaminal Lumbar Interbody – Product Description 59

SPIRA – Sacroiliac – Product Status 60

SPIRA – Sacroiliac – Product Description 60

SPIRA Open Matrix ALIF – Product Status 60

SPIRA Open Matrix ALIF – Product Description 61

SPIRA-L Open Matrix LLIF – Product Status 61

SPIRA-L Open Matrix LLIF – Product Description 61

Camber Spine Technologies LLC – Ongoing Clinical Trials Overview 62

SPIRA Open Matrix ALIF – SPIRA-A 3D Printed Titanium Anterior Lumbar Interbody Fusion Device and HCT/p Demineralized Bone Matrix Versus Medtronic Divergent-L/Perimeter PEEK Anterior Lumbar Interbody Fusion Device and Recombinant Bone Morphogenic Protein-2 63

Choice Spine LLC Pipeline Products & Ongoing Clinical Trials Overview 64

Expandable PEEK Interbody Cage – Product Status 64

Expandable PEEK Interbody Cage – Product Description 64

Next Generation Gibralt Spine System – Product Status 65

Next Generation Gibralt Spine System – Product Description 65

Next Generation Proliant Spine System – Product Status 65

Next Generation Proliant Spine System – Product Description 65

Clariance Inc Pipeline Products & Ongoing Clinical Trials Overview 66

Platform Access – Product Status 66

Platform Access – Product Description 66

Clariance SAS Pipeline Products & Ongoing Clinical Trials Overview 67

Erisma Deformity – Product Status 67

Erisma Deformity – Product Description 67

Clariance SAS – Ongoing Clinical Trials Overview 68

Erisma Deformity – Clariance Registry of ERISMA and Idys Devices 69

Corelink LLC Pipeline Products & Ongoing Clinical Trials Overview 70

3D Printed Cervical Titanium Interbody System – Product Status 70

3D Printed Cervical Titanium Interbody System – Product Description 70

3D Printed Lumbar Titanium Interbody System – Product Status 71

3D Printed Lumbar Titanium Interbody System – Product Description 71

Cervical Plate System – Product Status 71

Cervical Plate System – Product Description 71

Universal Pedicle Screw System – Product Status 72

Universal Pedicle Screw System – Product Description 72

Cortical Concepts (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 73

Cortical Anchor – Product Status 73

Cortical Anchor – Product Description 73

CTL Amedica Corp Pipeline Products & Ongoing Clinical Trials Overview 74

MONDRIAN PLIF Cage – Product Status 74

MONDRIAN PLIF Cage – Product Description 74

MONDRIAN TLIF Cage – Product Status 75

MONDRIAN TLIF Cage – Product Description 75

Sneak Peak – Product Status 75

Sneak Peak – Product Description 76

Cutting Edge Spine LLC Pipeline Products & Ongoing Clinical Trials Overview 77

EVOL HA-ALIF – Product Status 77

EVOL HA-ALIF – Product Description 77

Ventral Cervical Plate – Product Status 78

Ventral Cervical Plate – Product Description 78

DePuy Synthes Inc Pipeline Products & Ongoing Clinical Trials Overview 79

Expedium FAS 2 – Product Status 79

Expedium FAS 2 – Product Description 79

TLIF Cage – Product Status 80

TLIF Cage – Product Description 80

DSM Biomedical BV Pipeline Products & Ongoing Clinical Trials Overview 81

Graft Containment Device – Product Status 81

Graft Containment Device – Product Description 81

Porous Resorbable Interbody Spacer – Product Status 82

Porous Resorbable Interbody Spacer – Product Description 82

Spine Inter-Body Fusion Cage – Product Status 82

Spine Inter-Body Fusion Cage – Product Description 83

Structural Spine Implant – Product Status 83

Structural Spine Implant – Product Description 83

DSM Dyneema BV Pipeline Products & Ongoing Clinical Trials Overview 84

Dyneema Purity – Scoliosis – Product Status 84

Dyneema Purity – Scoliosis – Product Description 84

Eden Spine LLC Pipeline Products & Ongoing Clinical Trials Overview 85

PERFX-1 – Product Status 85

PERFX-1 – Product Description 85

EDGe Surgical Inc Pipeline Products & Ongoing Clinical Trials Overview 86

Next Gen Spine Awl-In-One Tap System – Product Status 86

Next Gen Spine Awl-In-One Tap System – Product Description 86

Eminent Spine LLC Pipeline Products & Ongoing Clinical Trials Overview 87

Anaconda – Product Status 87

Anaconda – Product Description 87

King Snake – Product Status 88

King Snake – Product Description 88

Queen Snake – Product Status 88

Queen Snake – Product Description 88

ErgoSpine Pipeline Products & Ongoing Clinical Trials Overview 89

ErgoFuse – Product Status 89

ErgoFuse – Product Description 89

Evoke Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 90

eHeal – Product Status 90

eHeal – Product Description 90

FacetMed Ltd Pipeline Products & Ongoing Clinical Trials Overview 91

DualAxis – Product Status 91

DualAxis – Product Description 91

PediWing Spinal Fixation System – Product Status 92

PediWing Spinal Fixation System – Product Description 92

Farmove Medical Pipeline Products & Ongoing Clinical Trials Overview 93

Interbody Fusion Device – Product Status 93

Interbody Fusion Device – Product Description 93

Fuse Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 94

Cervical Spinal Interbody Device – Product Status 94

Cervical Spinal Interbody Device – Product Description 94

Lumbar Spinal Interbody Device – Product Status 95

Lumbar Spinal Interbody Device – Product Description 95

GS Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 96

AnyPlus Anterior Cervical Plate – Product Status 96

AnyPlus Anterior Cervical Plate – Product Description 96

AnyPlus Posterior Cervical OCT Plate And Screw System – Product Status 97

AnyPlus Posterior Cervical OCT Plate And Screw System – Product Description 97

Chrome Cobalt Rod System – Product Status 97

Chrome Cobalt Rod System – Product Description 97

H. Lee Moffitt Cancer Center & Research Institute Inc Pipeline Products & Ongoing Clinical Trials Overview 98

Transdiscal Screw System – Product Status 98

Transdiscal Screw System – Product Description 98

HAPPE Spine LLC Pipeline Products & Ongoing Clinical Trials Overview 99

Cervical Peek Interbody Device – Product Status 99

Cervical Peek Interbody Device – Product Description 99

Lumbar PEEK Interbody Device – ALIF – Product Status 100

Lumbar PEEK Interbody Device – ALIF – Product Description 100

Lumbar PEEK Interbody Device – TLIF – Product Status 100

Lumbar PEEK Interbody Device – TLIF – Product Description 101

HD LifeSciences LLC Pipeline Products & Ongoing Clinical Trials Overview 102

Hive Cervical – Product Status 102

Hive Cervical – Product Description 102

Hive Cervical S – Product Status 103

Hive Cervical S – Product Description 103

Implanet SA Pipeline Products & Ongoing Clinical Trials Overview 104

Hybrid Fixation System – Product Status 104

Hybrid Fixation System – Product Description 105

ISS-JAZZ Screw System – Product Status 105

ISS-JAZZ Screw System – Product Description 105

Jazz Cap System – Product Status 106

Jazz Cap System – Product Description 106

JAZZ Evo – Product Status 106

JAZZ Evo – Product Description 107

Jazz Lock – Product Status 107

Jazz Lock – Product Description 107

JAZZ Passer Band – Product Status 108

JAZZ Passer Band – Product Description 108

JAZZ Standalone Implant – Product Status 108

JAZZ Standalone Implant – Product Description 109

Spinal Deformity Device – Product Status 109

Spinal Deformity Device – Product Description 109

Innospina LLC Pipeline Products & Ongoing Clinical Trials Overview 110

Spinal Fusion Implant – Product Status 110

Spinal Fusion Implant – Product Description 110

Innov’spine Pipeline Products & Ongoing Clinical Trials Overview 111

Intersomatic Cervical Implant – Product Status 111

Intersomatic Cervical Implant – Product Description 111

Intelligent Implant Systems LLC Pipeline Products & Ongoing Clinical Trials Overview 112

LSIF – Product Status 112

LSIF – Product Description 112

Mind Lumbar-Thoracic Spinal System – Product Status 113

Mind Lumbar-Thoracic Spinal System – Product Description 113

Intelligent Implants Pipeline Products & Ongoing Clinical Trials Overview 114

SmartFuse System – Product Status 114

SmartFuse System – Product Description 114

Jemo Spine, LLC. Pipeline Products & Ongoing Clinical Trials Overview 115

Alta – Anterior Cervical Plate – Product Status 115

Alta – Anterior Cervical Plate – Product Description 115

Moab Interbody Spacer – Product Status 116

Moab Interbody Spacer – Product Description 116

joimax GmbH Pipeline Products & Ongoing Clinical Trials Overview 117

Disc Preparation Tool – LIF – Product Status 117

Disc Preparation Tool – LIF – Product Description 117

LESspine LLC Pipeline Products & Ongoing Clinical Trials Overview 118

Expanding P-Lift – Product Status 118

Expanding P-Lift – Product Description 118

PedFuse REly – Product Status 119

PedFuse REly – Product Description 119

SIJ-Fuse Rod – Product Status 119

SIJ-Fuse Rod – Product Description 120

VBR (Vertebral Body Replacement) Device – Product Status 120

VBR (Vertebral Body Replacement) Device – Product Description 120

X-Visibl – Product Status 121

X-Visibl – Product Description 121

Lifespans Ltd Pipeline Products & Ongoing Clinical Trials Overview 122

Lifespans Soft Spine Implant – Product Status 122

Lifespans Soft Spine Implant – Product Description 122

Mayo Clinic Pipeline Products & Ongoing Clinical Trials Overview 123

Pedicle Screw Washer – Product Status 123

Pedicle Screw Washer – Product Description 123

Medicrea Group Pipeline Products & Ongoing Clinical Trials Overview 124

Corpectomy Implant – Product Status 124

Corpectomy Implant – Product Description 124

Medtronic Plc Pipeline Products & Ongoing Clinical Trials Overview 125

Anterior L1/S1 Spine Plates – Product Status 125

Anterior L1/S1 Spine Plates – Product Description 125

Osteoporosis And Cannulated Pedicle Screw System – Product Status 126

Osteoporosis And Cannulated Pedicle Screw System – Product Description 126

Solera Fenestrated Screw – Product Status 126

Solera Fenestrated Screw – Product Description 127

U Spine II – Product Status 127

U Spine II – Product Description 127

Medyssey Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 128

ATHENA – Product Status 128

ATHENA – Product Description 128

Mekanika Inc Pipeline Products & Ongoing Clinical Trials Overview 129

Modulus System – Product Status 129

Modulus System – Product Description 129

Mercy Health Research Pipeline Products & Ongoing Clinical Trials Overview 130

Spinous Process Device – Product Status 130

Spinous Process Device – Product Description 130

Mesoblast Ltd Pipeline Products & Ongoing Clinical Trials Overview 131

NeoFuse – Product Status 131

NeoFuse – Product Description 131

MI4 Spine, LLC Pipeline Products & Ongoing Clinical Trials Overview 132

Cervical Plate – Product Status 132

Cervical Plate – Product Description 132

MIS Interspinous Process Spacer – Product Status 133

MIS Interspinous Process Spacer – Product Description 133

MIS Pedicle Screw – Product Status 133

MIS Pedicle Screw – Product Description 134

PLIF/TLIF System – Product Status 134

PLIF/TLIF System – Product Description 134

Michigan State University Pipeline Products & Ongoing Clinical Trials Overview 135

X-Plant Spinal Fixator – Product Status 135

X-Plant Spinal Fixator – Product Description 135

MicroPort Scientific Corp Pipeline Products & Ongoing Clinical Trials Overview 136

Spine Plate – Product Status 136

Spine Plate – Product Description 136

Spine Screw – Product Status 137

Spine Screw – Product Description 137

N8 Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 138

Coated Pedicle Screw – Product Status 138

Coated Pedicle Screw – Product Description 138

Nanovis Inc Pipeline Products & Ongoing Clinical Trials Overview 139

FortiSpan CrossLink – Product Status 139

FortiSpan CrossLink – Product Description 139

Nasseo, Inc. Pipeline Products & Ongoing Clinical Trials Overview 140

3D Printed Spinal Implant – Product Status 140

3D Printed Spinal Implant – Product Description 140

NEOS Surgery SL Pipeline Products & Ongoing Clinical Trials Overview 141

NEOS Pedicle Screw System – Product Status 141

NEOS Pedicle Screw System – Product Description 141

Neumedix Surgical Pty Ltd Pipeline Products & Ongoing Clinical Trials Overview 142

NeuMedix Expanding Cervical Canal Device – Product Status 142

NeuMedix Expanding Cervical Canal Device – Product Description 142

Nexilis AG Pipeline Products & Ongoing Clinical Trials Overview 143

Immediate Stabilization System – Product Status 143

Immediate Stabilization System – Product Description 143

Nexilis AG – Ongoing Clinical Trials Overview 144

Immediate Stabilization System – Safety and Efficacy of the New ISS Sleeve Augmentation Technique in the Treatment of Osteoporotic/Osteopenic Vertebral Fractures in the Thoraco-lumbar Spine: A Pilot Study and Subsequent Comparison to the Standard PMMA-screw Augmentation 145

Nexxt Spine LLC Pipeline Products & Ongoing Clinical Trials Overview 146

Bone Healing Spinal Implant – Product Status 146

Bone Healing Spinal Implant – Product Description 146

Integrated Plate System – Product Status 147

Integrated Plate System – Product Description 147

Novadip Biosciences SA Pipeline Products & Ongoing Clinical Trials Overview 148

NVD-001 – Product Status 148

NVD-001 – Product Description 148

Novum Medical Products, Inc. Pipeline Products & Ongoing Clinical Trials Overview 149

Anterior Lumbar Interbody Fusion Device – Product Status 149

Anterior Lumbar Interbody Fusion Device – Product Description 149

Lateral Lumbar Interbody Fusion Device – Product Status 150

Lateral Lumbar Interbody Fusion Device – Product Description 150

Nutech Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 151

NuFix II Facet Fusion Dowel – Product Status 151

NuFix II Facet Fusion Dowel – Product Description 151

NuVasive Inc Pipeline Products & Ongoing Clinical Trials Overview 152

Reline Complex – Product Status 152

Reline Complex – Product Description 152

Reline Edge – Product Status 153

Reline Edge – Product Description 153

Reline One – Product Status 153

Reline One – Product Description 153

Orchid Orthopedic Solutions LLC Pipeline Products & Ongoing Clinical Trials Overview 154

Thru-Fuze Device – Product Status 154

Thru-Fuze Device – Product Description 154

Orthobond Pipeline Products & Ongoing Clinical Trials Overview 155

Antimicrobial Pedicle Screw System – Product Status 155

Antimicrobial Pedicle Screw System – Product Description 155

OsteoGeneX Inc Pipeline Products & Ongoing Clinical Trials Overview 156

Spinal Fusion Device – Product Status 156

Spinal Fusion Device – Product Description 156

OsteoVantage Inc Pipeline Products & Ongoing Clinical Trials Overview 157

INDOS System – Product Status 157

INDOS System – Product Description 157

Ozop Surgical Corp (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 158

Adjustable ALIF Interbody Spinal Implant – Product Status 158

Adjustable ALIF Interbody Spinal Implant – Product Description 158

Pharmaco-Kinesis Corp Pipeline Products & Ongoing Clinical Trials Overview 159

Intelligent Interbody Fusion Device – Product Status 159

Intelligent Interbody Fusion Device – Product Description 159

Precision Spine Inc Pipeline Products & Ongoing Clinical Trials Overview 160

ShurFit Coated T-PLIF Cage – Product Status 160

ShurFit Coated T-PLIF Cage – Product Description 160

Providence Medical Technology Inc Pipeline Products & Ongoing Clinical Trials Overview 161

Posterior Cervical Stabilization System – Product Status 161

Posterior Cervical Stabilization System – Product Description 161

Providence Medical Technology Inc – Ongoing Clinical Trials Overview 162

Posterior Cervical Stabilization System – Safety and Effectiveness of Posterior Cervical Stabilization System (PCSS) as an Adjunct to Posterior Cervical Fusion, When Used in Combination with ACDF in Treatment of Multi-level Cervical Degenerative Disease 163

RegeneEx Ltd. Pipeline Products & Ongoing Clinical Trials Overview 164

RegeneEx Minimally Invasive Device – Product Status 164

RegeneEx Minimally Invasive Device – Product Description 164

Resoimplant GmbH (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 165

Resospine – Product Status 165

Resospine – Product Description 165

RevBio Inc Pipeline Products & Ongoing Clinical Trials Overview 166

Tetranite – Spine Fusion – Product Status 166

Tetranite – Spine Fusion – Product Description 166

ReVivo Medical, LLC Pipeline Products & Ongoing Clinical Trials Overview 167

Cervical Spinal Fusion Plate – Product Status 167

Cervical Spinal Fusion Plate – Product Description 167

Sail Fusion LLC Pipeline Products & Ongoing Clinical Trials Overview 168

Spinal Fixation System – Product Status 168

Spinal Fixation System – Product Description 168

SANUWAVE Health Inc Pipeline Products & Ongoing Clinical Trials Overview 169

orthoPACE – Spinal Fusion – Product Status 169

orthoPACE – Spinal Fusion – Product Description 169

SeaSpine, Inc. Pipeline Products & Ongoing Clinical Trials Overview 170

3D-Printed Lateral Lumbar Interbody Device – Product Status 170

3D-Printed Lateral Lumbar Interbody Device – Product Description 170

3D-Printed Lumbar Interbody Device – Anterior Approach – Product Status 171

3D-Printed Lumbar Interbody Device – Anterior Approach – Product Description 171

ALIF With Locking Plate – Product Status 171

ALIF With Locking Plate – Product Description 171

Lateral Intervertebral Body Fusion Device – Product Status 172

Lateral Intervertebral Body Fusion Device – Product Description 172

Lordotic And Parallel Expandable PLIF Interbody Device – Product Status 172

Lordotic And Parallel Expandable PLIF Interbody Device – Product Description 172

Next Gen PLIF/TLIF Oblique Interbody Device – Product Status 173

Next Gen PLIF/TLIF Oblique Interbody Device – Product Description 173

Next Gen TLIF Articulating Anterior Interbody Device – Product Status 173

Next Gen TLIF Articulating Anterior Interbody Device – Product Description 174

Signus Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 175

Axioma-C – Product Status 175

Axioma-C – Product Description 175

SINTX Technologies Inc Pipeline Products & Ongoing Clinical Trials Overview 176

Biologically Enhanced Spinal Fusion Device – Product Status 176

Biologically Enhanced Spinal Fusion Device – Product Description 176

Composite Silicon Nitride Interbody Device – Product Status 177

Composite Silicon Nitride Interbody Device – Product Description 177

FleX SN Porous Spinal Implant – Product Status 177

FleX SN Porous Spinal Implant – Product Description 177

Spinal Balance Inc. Pipeline Products & Ongoing Clinical Trials Overview 178

Bioactive Facet Screw System – Product Status 178

Bioactive Facet Screw System – Product Description 178

Spinal Elements Inc Pipeline Products & Ongoing Clinical Trials Overview 179

Zyre Facet Implant System – Product Status 179

Zyre Facet Implant System – Product Description 179

Spinal Resources Inc Pipeline Products & Ongoing Clinical Trials Overview 180

Swedge Pedicle Screw Fixation System – 4.75 mm – Product Status 180

Swedge Pedicle Screw Fixation System – 4.75 mm – Product Description 181

Swedge Pedicle Screw Fixation System – 5.0 mm – Product Status 181

Swedge Pedicle Screw Fixation System – 5.0 mm – Product Description 182

Swedge Posterior Cervical Stabilization System – Product Status 182

Swedge Posterior Cervical Stabilization System – Product Description 182

Spinal Simplicity LLC Pipeline Products & Ongoing Clinical Trials Overview 183

Scarab – Product Status 183

Scarab – Product Description 183

SpinalVu Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 184

X – Wave Cervical Interbody Spacer – Product Status 184

X – Wave Cervical Interbody Spacer – Product Description 184

X – Wave Lumbar Interbody Spacer – Product Status 185

X – Wave Lumbar Interbody Spacer – Product Description 185

Spine Wave Inc Pipeline Products & Ongoing Clinical Trials Overview 186

CapSure PS2 Spine System – Product Status 186

CapSure PS2 Spine System – Product Description 186

SpineGuard SA Pipeline Products & Ongoing Clinical Trials Overview 187

PediGuard Spine SmartScrew – Product Status 187

PediGuard Spine SmartScrew – Product Description 187

SpineSmith Holdings LLC Pipeline Products & Ongoing Clinical Trials Overview 188

Cervical Interbody Device – Product Status 188

Cervical Interbody Device – Product Description 188

Closed VisuALIF – Product Status 189

Closed VisuALIF – Product Description 189

Facet Fixation Device – Product Status 189

Facet Fixation Device – Product Description 190

Posterior Lumbar Interbody Fusion Device – Product Status 190

Posterior Lumbar Interbody Fusion Device – Product Description 190

SpineVision SA Pipeline Products & Ongoing Clinical Trials Overview 191

Flex+2 – Product Status 191

Flex+2 – Product Description 191

Sree Chitra Tirunal Institute for Medical Sciences & Technology Pipeline Products & Ongoing Clinical Trials Overview 192

Spinal Fixation System – Product Status 192

Spinal Fixation System – Product Description 192

Stryker Corp Pipeline Products & Ongoing Clinical Trials Overview 193

AlloCraft C-Ring – Product Status 193

AlloCraft C-Ring – Product Description 193

Bioactive Inter-body Device – Product Status 194

Bioactive Inter-body Device – Product Description 194

Spiral Radius 90D Spinal System – Product Status 194

Spiral Radius 90D Spinal System – Product Description 195

Taragenyx Ltd (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 196

TRGYX-001 – Product Status 196

TRGYX-001 – Product Description 196

Theradaptive Inc Pipeline Products & Ongoing Clinical Trials Overview 197

OsteoAdapt SP Spinal Fusion Implant – Product Status 197

OsteoAdapt SP Spinal Fusion Implant – Product Description 197

Tissue Regeneration Systems, Inc. Pipeline Products & Ongoing Clinical Trials Overview 198

TRS Bioactive Implant – Spinal Fusion Surgery – Product Status 198

TRS Bioactive Implant – Spinal Fusion Surgery – Product Description 198

TranS1 Inc Pipeline Products & Ongoing Clinical Trials Overview 199

KeyLIF – Product Status 199

KeyLIF – Product Description 199

TruSpine Technologies Plc Pipeline Products & Ongoing Clinical Trials Overview 200

Cervi-LOK – Product Status 200

Cervi-LOK – Product Description 200

Faci-LOK – Product Status 201

Faci-LOK – Product Description 201

GRASP Laminoplasty Device – Product Status 201

GRASP Laminoplasty Device – Product Description 202

University of Colorado Pipeline Products & Ongoing Clinical Trials Overview 203

Laminoplasty Distractor System – Product Status 203

Laminoplasty Distractor System – Product Description 203

University of Colorado Anschutz Medical Campus Pipeline Products & Ongoing Clinical Trials Overview 204

Anterior Cervical Plating System – Product Status 204

Anterior Cervical Plating System – Product Description 204

University of Pittsburgh Pipeline Products & Ongoing Clinical Trials Overview 205

Self-Powered Smart Implant – Product Status 205

Self-Powered Smart Implant – Product Description 205

University of South Florida Pipeline Products & Ongoing Clinical Trials Overview 206

Asymmetric Disc Distracting Cage – Product Status 206

Asymmetric Disc Distracting Cage – Product Description 206

Cervical Plating System – Product Status 207

Cervical Plating System – Product Description 207

Occipito-Cervical Fixation Device – Product Status 207

Occipito-Cervical Fixation Device – Product Description 208

Polyaxial Fixation Device – Product Status 208

Polyaxial Fixation Device – Product Description 208

Polyaxial Screw Head – Product Status 209

Polyaxial Screw Head – Product Description 209

University of Toledo Pipeline Products & Ongoing Clinical Trials Overview 210

Anchoring Pedicle Screw – Product Status 210

Anchoring Pedicle Screw – Product Description 210

Bioactive Fusion Device – Product Status 211

Bioactive Fusion Device – Product Description 211

Pedicle Screw – Surgical Correction Of Spinal Deformities – Product Status 211

Pedicle Screw – Surgical Correction Of Spinal Deformities – Product Description 212

Retractable Pedicle Screw Assembly – Product Status 212

Retractable Pedicle Screw Assembly – Product Description 212

Shape Memory Alloy Pedicle Screw – Product Status 213

Shape Memory Alloy Pedicle Screw – Product Description 213

Spinal Deformity Correction Device – Product Status 213

Spinal Deformity Correction Device – Product Description 214

Stabilized Spinal Fixation Hook – Product Status 214

Stabilized Spinal Fixation Hook – Product Description 214

Transpedicular Accessing Device – Product Status 215

Transpedicular Accessing Device – Product Description 215

University of Utah Pipeline Products & Ongoing Clinical Trials Overview 216

Wasatch Loop System – Product Status 216

Wasatch Loop System – Product Description 216

University of Virginia Pipeline Products & Ongoing Clinical Trials Overview 217

Spinal Implant – Product Status 217

Spinal Implant – Product Description 217

VersaSpine LLC Pipeline Products & Ongoing Clinical Trials Overview 218

VersaSpine Dual-Ended Pedicle Screw System – Product Status 218

VersaSpine Dual-Ended Pedicle Screw System – Product Description 218

Vertech Inc Pipeline Products & Ongoing Clinical Trials Overview 219

Rotoplasty System – VCF – Product Status 219

Rotoplasty System – VCF – Product Description 219

Verticor (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 220

VClipse Cervical Plating System – Product Status 220

VClipse Cervical Plating System – Product Description 220

VGI Medical LLC Pipeline Products & Ongoing Clinical Trials Overview 221

VerteLX – Product Status 221

VerteLX – Product Description 221

White Light Medical Pipeline Products & Ongoing Clinical Trials Overview 222

AccuSpine – Product Status 222

AccuSpine – Product Description 222

Xtant Medical Holdings Inc Pipeline Products & Ongoing Clinical Trials Overview 223

Interbody Fusion Device – Product Status 223

Interbody Fusion Device – Product Description 223

Xtremity & Spinal Solutions Ltd Pipeline Products & Ongoing Clinical Trials Overview 224

FILL AND FIX PEEK OPTIMA ANATOMIC Cervical Cage – Product Status 224

FILL AND FIX PEEK OPTIMA ANATOMIC Cervical Cage – Product Description 224

FILL AND FIX PEEK OPTIMA ANATOMIC Lumbar Cage – Product Status 225

FILL AND FIX PEEK OPTIMA ANATOMIC Lumbar Cage – Product Description 225

Yunyi (Beijing) Medical Device Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 226

3D Printed PEEK Artificial Vertebral Body – Product Status 226

3D Printed PEEK Artificial Vertebral Body – Product Description 226

Zyga Technology Inc Pipeline Products & Ongoing Clinical Trials Overview 227

Glyder Facet Resurfacing System – Product Status 227

Glyder Facet Resurfacing System – Product Description 227

ZygoFix Ltd Pipeline Products & Ongoing Clinical Trials Overview 228

ZLock Cervical Implant – Product Status 228

ZLock Cervical Implant – Product Description 228

ZLock Lumbar Spinal Fusion System – Product Status 229

ZLock Lumbar Spinal Fusion System – Product Description 229

ZLock SI Implant – Product Status 229

ZLock SI Implant – Product Description 230

ZygoFix Ltd – Ongoing Clinical Trials Overview 231

ZLock Lumbar Spinal Fusion System – A Clinical Study to Evaluate the Efficacy of zLOCK Spinal Facet Joint Fixation System in the Treatment of Severe Back and Leg Pain 232

ZLock Lumbar Spinal Fusion System – A Multi-center Pivotal Study of ZLOCK System for the Treatment of Chronic Back Pain 232

ZLock Lumbar Spinal Fusion System – Safety and Efficacy Assessment of the zLock Facet Fusion System- A Pilot Study 232

ZLock Lumbar Spinal Fusion System – Safety and Efficacy Assessment of Using the zLOCK Facet Stabilization System 233

Glossary 323

List of Figures

Spinal Fusion – Pipeline Products by Stage of Development 22

Spinal Fusion – Pipeline Products by Segment 23

Spinal Fusion – Pipeline Products by Territory 24

Spinal Fusion – Pipeline Products by Regulatory Path 25

Spinal Fusion – Pipeline Products by Estimated Approval Date 26

Spinal Fusion – Ongoing Clinical Trials 27

Frequently Asked Questions

The interbody devices segment is leading in the market in 2023.

As of June 2023, the US has the highest number of pipeline products in the spinal fusion pipeline market.

As of June 2023, 510(k) is the most followed regulatory pathway in the spinal fusion pipeline market.

Some of the major players operating in the spinal fusion pipeline market are AMB Surgical II LLC, APTO Orthopaedics, Aurora Spine Corp, Biedermann Motech GmbH & Co KG, and Bio2 Technologies Inc among others.

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