Shoulder Replacement Pipeline by Development Stages, Segments, Region and Countries, Regulatory Path and Key Companies

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Published: July 16, 2024 Report Code: GDME1775EPD-ST

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Shoulder Replacement Pipeline Market Report Overview

Shoulder replacement is a surgical procedure in which certain parts of an arthritic or damaged joint are removed and replaced with prosthesis, or artificial joints. The shoulder replacement pipeline market research report provides a comprehensive understanding of the pipeline products along with their comparative analysis at various stages of development. The report also includes information about the territories wherein the clinical trials are in progress, the regulatory paths followed by the trials, and the companies associated with the trials.

Key Segments ·       Reverse Shoulder Replacement

·       Total/Primary Shoulder Replacement

·       Partial Shoulder Replacement

·       Revision Shoulder Replacement

·       Shoulder Resurfacing
Key Territories ·       Europe

·       The United States

·       China

·       Canada
Key Regulatory Paths ·       CE

·       510(k)

·       NMPA

·       PMA

·       MDL
Leading Companies ·       BioPoly LLC

·       CeramTec GmbH

·       CytexOrtho

·       Exactech Inc

·       FX Shoulder USA Inc
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Shoulder Replacement Pipeline Market Segmentation by Segments

The key segments in the shoulder replacement pipeline market are reverse shoulder replacement, total/primary shoulder replacement, partial shoulder replacement, revision shoulder replacement, and shoulder resurfacing. As of July 2024, reverse shoulder replacement and total/primary shoulder replacement have an equal number of pipeline products.

Shoulder Replacement Pipeline Market Analysis by Segments, 2024 (%)

Shoulder Replacement Pipeline Market Analysis by Segments, 2024 (%)

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Shoulder Replacement Pipeline Market Segmentation by Territories

A few of the key territories with the shoulder replacement pipeline market are Europe, the United States, China, and Canada among others. As of July 2024, the US had the highest number of shoulder replacement pipeline products.

Shoulder Replacement Pipeline Market Analysis by Territories, 2024 (%)

Shoulder Replacement Pipeline Market Analysis by Territories, 2024 (%)

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Shoulder Replacement Pipeline Market Segmentation by Regulatory Paths

A few of the key regulatory paths in the shoulder replacement pipeline products market are CE, 510(k), NMPA, PMA, and MDL. As of July 2024, 510(k) was the most followed pathway for pipeline products in the shoulder replacement market.

Shoulder Replacement Pipeline Market Analysis by Regulatory Paths, 2024 (%)

Shoulder Replacement Pipeline Market Analysis by Regulatory Paths, 2024 (%)

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Shoulder Replacement Pipeline Market – Competitive Landscape

A few of the key companies associated with the shoulder replacement pipeline market are BioPoly LLC, CeramTec GmbH, CytexOrtho, Exactech Inc., and FX Shoulder USA Inc. among others.

Exactech Inc: Exactech is a medical device company that develops and markets orthopedic implant devices and related surgical instruments. The company’s products comprise hip implants, shoulder implants, knee implants, extremity implants, and ExactechGPS systems, among others. It provides ambulatory surgery centers, infection-related solutions, and biological services. The company also offers an Active Intelligence platform of smart technologies to hospitals and physicians.

Shoulder Replacement Pipeline Market Analysis by Companies, 2024
Shoulder Replacement Pipeline Market Analysis by Companies, 2024 Buy the Full Report for More Company Insights into the Shoulder Replacement Pipeline Market
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Segments Covered in the Report

Shoulder Replacement Pipeline Market Segments Outlook (2024)

  • Reverse Shoulder Replacement
  • Total/Primary Shoulder Replacement
  • Partial Shoulder Replacement
  • Revision Shoulder Replacement
  • Shoulder Resurfacing

Shoulder Replacement Pipeline Market Territories Outlook (2024)

  • Europe
  • The United States
  • China
  • Canada
  • Global

Shoulder Replacement Pipeline Market Regulatory Paths Outlook (2024)

  • CE
  • 510(k)
  • NMPA
  • PMA
  • MDL

Scope

This report provides:

  • Extensive coverage of the shoulder replacement under development.

  • Exhaustive list of major pipeline products and their details, including product description, licensing and collaboration details, and other developmental activities.

  • Reviews of major players involved in the development of shoulder replacement and lists all their pipeline projects.

  • Coverage of pipeline products based on various stages of development ranging from early development to approved/issued stage.

  • Key clinical trial data of ongoing clinical trials specific to pipeline products.

  • Recent developments in the segment/industry.

Reasons to Buy

  • 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 shoulder replacement under development.

  • Develop market-entry and market-expansion strategies.

  • Plan mergers and acquisitions effectively by identifying major players with the most promising pipeline.

  • Carry out an in-depth analysis of the product’s current stage of development, territory, and estimated launch date.

BioPoly LLC
CeramTec GmbH
CytexOrtho
Exactech Inc
FX Shoulder USA Inc
Hospital for Special Surgery
Imperial College London
Innovative Design Orthopaedics Ltd
Integra LifeSciences Holdings Corp
Lifespans Ltd
Limacorporate SpA
Materialise NV
Orbis Medisch Centrum
Shanghai EndoPhix Medical Technology Co Ltd
Shoulder Innovations LLC
Shoulder Options, Inc.
Smith & Nephew Plc
Stryker Corp
Topsfield Medical GmbH
University of Utah
Wright Medical Group NV (Inactive)
Zimmer Biomet Holdings Inc

Table of Contents

|1 Table of Contents 3

|1.1 List of Tables 6

|1.2 List of Figures 9

2 Introduction 10

2.1 Shoulder Replacement Overview 10

3 Products under Development 11

3.1 Shoulder Replacement – Pipeline Products by Stage of Development 11

3.2 Shoulder Replacement – Pipeline Products by Segment 12

3.3 Shoulder Replacement – Pipeline Products by Territory 13

3.4 Shoulder Replacement – Pipeline Products by Regulatory Path 14

3.5 Shoulder Replacement – Pipeline Products by Estimated Approval Date 15

3.6 Shoulder Replacement – Ongoing Clinical Trials 16

4 Shoulder Replacement – Pipeline Products under Development by Companies 17

4.1 Shoulder Replacement Companies – Pipeline Products by Stage of Development 17

4.2 Shoulder Replacement – Pipeline Products by Stage of Development 18

5 Shoulder Replacement Companies and Product Overview 19

5.1 BioPoly LLC Company Overview 19

5.1.1 BioPoly LLC Pipeline Products & Ongoing Clinical Trials Overview 19

5.2 CeramTec GmbH Company Overview 20

5.2.1 CeramTec GmbH Pipeline Products & Ongoing Clinical Trials Overview 20

5.3 CytexOrtho Company Overview 21

5.3.1 CytexOrtho Pipeline Products & Ongoing Clinical Trials Overview 21

5.4 Exactech Inc Company Overview 22

5.4.1 Exactech Inc Pipeline Products & Ongoing Clinical Trials Overview 22

5.5 FX Shoulder USA Inc Company Overview 25

5.5.1 FX Shoulder USA Inc Pipeline Products & Ongoing Clinical Trials Overview 25

5.6 Hospital for Special Surgery Company Overview 28

5.6.1 Hospital for Special Surgery Pipeline Products & Ongoing Clinical Trials Overview 28

5.7 Imperial College London Company Overview 29

5.7.1 Imperial College London Pipeline Products & Ongoing Clinical Trials Overview 29

5.8 Innovative Design Orthopaedics Ltd Company Overview 30

5.8.1 Innovative Design Orthopaedics Ltd Pipeline Products & Ongoing Clinical Trials Overview 30

5.9 Integra LifeSciences Holdings Corp Company Overview 31

5.9.1 Integra LifeSciences Holdings Corp Pipeline Products & Ongoing Clinical Trials Overview 31

5.10 Lifespans Ltd Company Overview 37

5.10.1 Lifespans Ltd Pipeline Products & Ongoing Clinical Trials Overview 37

5.11 Limacorporate SpA Company Overview 38

5.11.1 Limacorporate SpA Pipeline Products & Ongoing Clinical Trials Overview 38

5.12 Materialise NV Company Overview 41

5.12.1 Materialise NV Pipeline Products & Ongoing Clinical Trials Overview 41

5.13 Orbis Medisch Centrum Company Overview 45

5.13.1 Orbis Medisch Centrum Pipeline Products & Ongoing Clinical Trials Overview 45

5.14 Shanghai EndoPhix Medical Technology Co Ltd Company Overview 46

5.14.1 Shanghai EndoPhix Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 46

5.15 Shoulder Innovations LLC Company Overview 47

5.15.1 Shoulder Innovations LLC Pipeline Products & Ongoing Clinical Trials Overview 47

5.16 Shoulder Options, Inc. Company Overview 48

5.16.1 Shoulder Options, Inc. Pipeline Products & Ongoing Clinical Trials Overview 48

5.17 Smith & Nephew Plc Company Overview 51

5.17.1 Smith & Nephew Plc Pipeline Products & Ongoing Clinical Trials Overview 51

5.18 Stryker Corp Company Overview 52

5.18.1 Stryker Corp Pipeline Products & Ongoing Clinical Trials Overview 52

5.19 Topsfield Medical GmbH Company Overview 53

5.19.1 Topsfield Medical GmbH Pipeline Products & Ongoing Clinical Trials Overview 53

5.20 University of Utah Company Overview 54

5.20.1 University of Utah Pipeline Products & Ongoing Clinical Trials Overview 54

5.21 Wright Medical Group NV (Inactive) Company Overview 55

5.21.1 Wright Medical Group NV (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 55

5.22 Zimmer Biomet Holdings Inc Company Overview 56

5.22.1 Zimmer Biomet Holdings Inc Pipeline Products & Ongoing Clinical Trials Overview 56

6 Shoulder Replacement- Recent Developments 57

6.1 Jun 25, 2024: Zimmer Receives Additional 510(K) Clearance For Identity Shoulder System 57

6.2 Jun 13, 2024: Encore Medical Receives 510(K) Clearance For AltiVate Reverse Glenoid 57

6.3 Jun 12, 2024: Exactech Announces First Shoulder Surgeries Using Comprehensive Trauma Shoulder Plates 57

6.4 Jun 06, 2024: Materialise Obtains An Additional 510(K) Clearance For Materialise Shoulder System 58

6.5 May 30, 2024: FX Shoulder USA Receives 510(k) Clearance For Full Wedge Lateralized And Augmented Baseplate 58

6.6 May 20, 2024: Shoulder Innovations Launches InSet 95 Humeral Stem 58

6.7 May 02, 2024: Zimmer Biomet Announces First Quarter 2024 Financial Results 59

6.8 Apr 19, 2024: Catalyst OrthoScience Receives 510(K) Clearance For Catalyst F1x Shoulder System 60

6.9 Apr 01, 2024: Fix Surgical Receives FDA 510(k) Clearance for Augment Off-Axis Instrument System 60

6.10 Mar 19, 2024: Celebrating 20 Years of Clinical Success with the Equinoxe Shoulder 60

6.11 Feb 28, 2024: Integra LifeSciences Announces Leadership Transition Plan 62

6.12 Feb 24, 2024: implantcast Received Additional 510(K) Clearance For AGILON XO Shoulder Replacement System 63

6.13 Feb 13, 2024: Smith+Nephew Announces Commercial Launch of Its AETOS Shoulder System for Anatomic and Reverse Shoulder Replacement at AAOS 2024 Annual Meeting 63

6.14 Feb 12, 2024: Enovis to Highlight Latest Technologies Across the Orthopedic Care Continuum at 2024 AAOS Annual Meeting 64

6.15 Feb 12, 2024: Smith+Nephew to attend AAOS 2024 Annual Meeting 65

6.16 Feb 12, 2024: Smith+Nephew to Attend AAOS 2024 Annual Meeting 65

6.17 Feb 08, 2024: Exactech Partners with Statera Medical to Co-Develop World’s First Smart Reverse Shoulder Implant 66

6.18 Jan 31, 2024: Stryker Corp Reports Strong Q4 and Full Year 2023 Results; Forecasts Continued Growth 66

6.19 Jan 29, 2024: Limacorporate Receives 510(K) Clearance For PRIMA Humeral System 66

6.20 Jan 16, 2024: Risks with Exactech Equinoxe Shoulder System with Defective Packaging – FDA Safety Communication 67

6.21 Jan 04, 2024: Limacorporate Receives 510(k) Clearance for SMR Hybrid Glenoid System 68

6.22 Nov 29, 2023: Waldemar Link Receives Additional 510(K) Clearance For LINK Embrace Shoulder System – Reverse Configuration 68

6.23 Nov 23, 2023: DePuy Ireland Receives 510(K) Clearance For INHANCE Shoulder System Convertible Glenoid Insert 68

6.24 Nov 23, 2023: DePuy Ireland Receives 510(K) Clearance For INHANCE Convertible Glenoid 69

6.25 Nov 22, 2023: Medacta International Receives 510(K) Clearance For Glenoid Reconstruction System – Full Wedge Baseplate 69

6.26 Nov 03, 2023: Advanced treatments target advanced shoulder issues 69

6.27 Oct 19, 2023: Arthrex Receives Additional 510(k) Clearance for Arthrex Univers Apex 70

6.28 Oct 11, 2023: Catalyst OrthoScience Receives Additional 510(K) Clearance For Archer R1 Reverse Shoulder System 70

6.29 Oct 09, 2023: Stryker to Host Investor Day 70

6.30 Oct 02, 2023: Shoulder Innovations Announces Placement of New Cfo and New Vp Commercial Development 71

6.31 Oct 02, 2023: Stryker to Announce Financial Results for Its Third Quarter of Fiscal Year 2023 71

6.32 Sep 28, 2023: Materialise Receives Additional 510(k) Clearance for Materialise Shoulder System 71

6.33 Sep 28, 2023: Exactech Obtains 510(k) Clearance for Exactech Equinoxe Reverse Humeral Adapter Tray 72

6.34 Sep 28, 2023: Exactech Obtains 510(k) Clearance for Exactech Equinoxe Reverse Humeral Liner 72

6.35 Sep 19, 2023: Anika Announces the Full Market Release of the RevoMotion Reverse Shoulder Arthroplasty System during the 2023 Orthopaedic Summit: Evolving Technologies (OSET) Annual Meeting 72

6.36 Sep 14, 2023: Exactech Presents New Shoulder Research Studies at Global Conference 74

6.37 Sep 14, 2023: Smith & Nephew Brings BT Chief Financial Officer Simon Lowth to Board 74

6.38 Sep 14, 2023: New Non Executive Directors Join the Board at Med Tech Business 75

6.39 Sep 14, 2023: Smith & Nephew Announces Board Changes 75

6.40 Sep 05, 2023: Zimmer Biomet Announces Key Updates to Company’s Executive Leadership Team 76

6.41 Aug 22, 2023: Zimmer Biomet Announces Leadership Transition 77

6.42 Aug 01, 2023: DePuy Synthes Receives Additional 510(k) Clearance for INHANCE Shoulder System 78

6.43 Jul 25, 2023: Biomet Orthopedics Receives Additional 510(K) Clearance for Comprehensive Segmental Revision System 78

7 Appendix 79

7.1 Methodology 79

7.2 About GlobalData 82

7.3 Contact Us 82

7.4 Disclaimer 82

Table

Shoulder Replacement – Pipeline Products by Stage of Development 11

Shoulder Replacement – Pipeline Products by Segment 12

Shoulder Replacement – Pipeline Products by Territory 13

Shoulder Replacement – Pipeline Products by Regulatory Path 14

Shoulder Replacement – Pipeline Products by Estimated Approval Date 15

Shoulder Replacement – Ongoing Clinical Trials 16

Shoulder Replacement Companies – Pipeline Products by Stage of Development 17

Shoulder Replacement – Pipeline Products by Stage of Development 18

BioPoly LLC Pipeline Products & Ongoing Clinical Trials Overview 19

BioPoly RS Partial Resurfacing Shoulder – Product Status 19

BioPoly RS Partial Resurfacing Shoulder – Product Description 19

CeramTec GmbH Pipeline Products & Ongoing Clinical Trials Overview 20

BIOLOX Delta – Shoulder Arthroplasty – Product Status 20

BIOLOX Delta – Shoulder Arthroplasty – Product Description 20

CytexOrtho Pipeline Products & Ongoing Clinical Trials Overview 21

Bio-Artificial Cartilage Implant – Regenerative Rotator Cuff Repair – Product Status 21

Bio-Artificial Cartilage Implant – Regenerative Rotator Cuff Repair – Product Description 21

Exactech Inc Pipeline Products & Ongoing Clinical Trials Overview 22

Ceramic Glenosphere – Product Status 22

Ceramic Glenosphere – Product Description 22

Revision/Tumor Humeral Stem – Product Status 23

Revision/Tumor Humeral Stem – Product Description 23

Shoulder System – Product Status 23

Shoulder System – Product Description 23

Smart Reverse Shoulder Implant – Product Status 24

Smart Reverse Shoulder Implant – Product Description 24

FX Shoulder USA Inc Pipeline Products & Ongoing Clinical Trials Overview 25

Easytech Reversed Stemless Device – Product Status 25

Easytech Reversed Stemless Device – Product Description 25

FX Shoulder USA Inc – Ongoing Clinical Trials Overview 26

Easytech Reversed Stemless Device – Pivotal, Non-randomized, Historically Controlled, Prospective, Multi-center Clinical Study of the Easytech Reversed Shoulder System 27

Easytech Reversed Stemless Device – Post Market Clinical Follow-up Study for Arthroplasty Shoulder System of FX Solutions at the Long Term Retro-Prospective, Non-Randomized, Non-Interventional Study 27

Hospital for Special Surgery Pipeline Products & Ongoing Clinical Trials Overview 28

Patient Specific Shoulder Arthroplasty Guide – Product Status 28

Patient Specific Shoulder Arthroplasty Guide – Product Description 28

Imperial College London Pipeline Products & Ongoing Clinical Trials Overview 29

Total Shoulder Replacement System – Product Status 29

Total Shoulder Replacement System – Product Description 29

Innovative Design Orthopaedics Ltd Pipeline Products & Ongoing Clinical Trials Overview 30

Verso Shoulder System – Product Status 30

Verso Shoulder System – Product Description 30

Integra LifeSciences Holdings Corp Pipeline Products & Ongoing Clinical Trials Overview 31

Advanced Glenoid Platform – Product Status 31

Advanced Glenoid Platform – Product Description 32

Advanced Shoulder System – Product Status 32

Advanced Shoulder System – Product Description 32

Conventional Pegged Glenoid – Product Status 32

Conventional Pegged Glenoid – Product Description 33

Next-Generation Shoulder Replacement System – Product Status 33

Next-Generation Shoulder Replacement System – Product Description 33

PyroCarbon Hemi Shoulder – Product Status 34

PyroCarbon Hemi Shoulder – Product Description 34

Pyrocarbon HRA – Product Status 34

Pyrocarbon HRA – Product Description 35

Short Stem Shoulder System – Product Status 35

Short Stem Shoulder System – Product Description 35

Stemless Shoulder System – Product Status 35

Stemless Shoulder System – Product Description 36

Lifespans Ltd Pipeline Products & Ongoing Clinical Trials Overview 37

Lifespans Soft Shoulder Implant – Product Status 37

Lifespans Soft Shoulder Implant – Product Description 37

Limacorporate SpA Pipeline Products & Ongoing Clinical Trials Overview 38

SMR Stemless Reverse Shoulder System – Product Status 38

SMR Stemless Reverse Shoulder System – Product Description 38

Limacorporate SpA – Ongoing Clinical Trials Overview 39

SMR Stemless Reverse Shoulder System – A Randomized, Multi-Center, Prospective, Safety and Efficacy Study Comparing the Outcome of Total Reverse Shoulder Arthroplasty (RSA) with SMR Stemless Reverse vs SMR Reverse Shoulder System 40

Materialise NV Pipeline Products & Ongoing Clinical Trials Overview 41

Glenius Glenoid Reconstruction System – Product Status 41

Glenius Glenoid Reconstruction System – Product Description 42

Materialise NV – Ongoing Clinical Trials Overview 43

Glenius Glenoid Reconstruction System – Long Term Follow-up after Primary or Revision Shoulder Arthroplasty with a Patient- Specific Glenius Implant: A Prospective Cohort Study 44

Orbis Medisch Centrum Pipeline Products & Ongoing Clinical Trials Overview 45

Shoulder Implant – Product Status 45

Shoulder Implant – Product Description 45

Shanghai EndoPhix Medical Technology Co Ltd Pipeline Products & Ongoing Clinical Trials Overview 46

Archimedes Implantable Rotator Cuff Spacer System – Product Status 46

Archimedes Implantable Rotator Cuff Spacer System – Product Description 46

Shoulder Innovations LLC Pipeline Products & Ongoing Clinical Trials Overview 47

InSet Stemless Humeral Implant – Reverse Articular Configuration – Product Status 47

InSet Stemless Humeral Implant – Reverse Articular Configuration – Product Description 47

Shoulder Options, Inc. Pipeline Products & Ongoing Clinical Trials Overview 48

AFT Proximal Humerus Fracture Prosthesis – Product Status 48

AFT Proximal Humerus Fracture Prosthesis – Product Description 48

aSpire Total Shoulder Arthroplasty System – Product Status 49

aSpire Total Shoulder Arthroplasty System – Product Description 49

Luna Anchored Stemless Humeral Prosthesis – Product Status 49

Luna Anchored Stemless Humeral Prosthesis – Product Description 50

Luna Stemless Humeral Prosthesis – Product Status 50

Luna Stemless Humeral Prosthesis – Product Description 50

Smith & Nephew Plc Pipeline Products & Ongoing Clinical Trials Overview 51

AETOS Next-Generation Shoulder System – Product Status 51

AETOS Next-Generation Shoulder System – Product Description 51

Stryker Corp Pipeline Products & Ongoing Clinical Trials Overview 52

ReUnion Stemless – Product Status 52

ReUnion Stemless – Product Description 52

Topsfield Medical GmbH Pipeline Products & Ongoing Clinical Trials Overview 53

Next Generation Shoulder Replacement System – Product Status 53

Next Generation Shoulder Replacement System – Product Description 53

University of Utah Pipeline Products & Ongoing Clinical Trials Overview 54

Short-stemmed Humeral Prosthetic Implant – Product Status 54

Short-stemmed Humeral Prosthetic Implant – Product Description 54

Wright Medical Group NV (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 55

PYC Humeral Head – Product Status 55

PYC Humeral Head – Product Description 55

Zimmer Biomet Holdings Inc Pipeline Products & Ongoing Clinical Trials Overview 56

Next Generation Stemless Shoulder – Product Status 56

Next Generation Stemless Shoulder – Product Description 56

Glossary 81

Figures

Shoulder Replacement – Pipeline Products by Stage of Development 11

Shoulder Replacement – Pipeline Products by Segment 12

Shoulder Replacement – Pipeline Products by Territory 13

Shoulder Replacement – Pipeline Products by Regulatory Path 14

Shoulder Replacement – Pipeline Products by Estimated Approval Date 15

Shoulder Replacement – Ongoing Clinical Trials 16

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