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US Market Report for ACL/PCL Fixation Devices 2017 - MedCore

US Market Report for ACL/PCL Fixation Devices 2017 - MedCore

General Report Contents

  • Market Analyses include: Unit Sales, ASPs, Market Value & Growth Trends
  • Market Drivers & Limiters for each chapter segment
  • Competitive Analysis for each chapter segment
  • Section on recent mergers & acquisitions
In tibial fixation, the most commonly used devices are interference screws. Although interference screws have long been the standard for tibial fixation, there is a trend towards newer technologies such as intratunnel devices. One of the setbacks of using interference screws is that the graft tends to twist around the screw as it is being inserted, causing the graft to lose its native anatomical position in the joint. This problem is solved by intratunnel devices which are commonly composed of a sheath and screw system. The sheath protects the graft from moving so that it better retains its anatomical rotation. It also pushes the graft closer up against the tibial tunnel, giving more graft to bone contact, which enhances the healing of the tunnel wall. Since tibial bone tends to be less dense than femoral bone, surgeons sometimes use washers and posts as a backup to intratunnel fixation devices. They do this mainly if they feel the patient has poor bone quality, leading to weaker fixation. Overall, this segment of the market is much smaller than the interference screw and intratunnel device market, and it is also declining with the emergence of newer, stronger fixation technologies.

For the femoral side, cortical fixation devices are most commonly used. These devices flip on the cortical surface and anchor the graft to the femoral tunnel, and thus do not rely on cancellous bone for fixation. Cross-pins are the second most popular femoral fixation device and have been developed to retain the graft ligament within the bone tunnel by securing it with a pin, extending transversely through the tunnel and the ligament. Interference screws are also used for fixing soft tissue to femoral bone; however, they are not as popular for use in the femur as in the tibia since the femur is denser than the tibia. Intratunnel devices also exist for femoral fixation; however, the number of products available is more limited than for tibial fixation.

The interference screw market for both tibial and femoral fixation can be further segmented into the different types of materials that are available for these products. In 2014, four different materials for interference screws existed: first generation resorbables, second generation resorbables, non-absorbable polymers and non-resorbables.

First generation resorbables have since been losing share to newer materials, such as second generation resorbables (with a calcium-type mineral component) and non-absorbable polymers (including polyetheretherketone (PEEK) and polyester materials), that became available in late 2007. First generation resorbables are composed of materials that are absorbed by the body after surgery and eventually disappear, such as polylactic acid (PLA/PLLA) or polylactic-co-glycolic acid (PLGA). From this point forward, first generation resorbables will be referred to as the PLA resorbables.

Second generation resorbables contain a synthetic copolymer of tricalcium phosphate (TCP) or hydroxyapatite (HAP) and as such are most commonly referred to as biocomposites. These screws are an evolution of the standard PLA polymer because the calcium-type mineral component blended into them encourages bone in growth during device absorption by the body. Due to the fact that a portion of the PLA material is removed, they also produce less adverse soft tissue reactions.

Non-resorbable polymer interference screws are most commonly composed of PEEK materials and will be referred to as the PEEK segment in this chapter. PEEK material is gaining acceptance in the medical community as it does not produce an adverse inflammatory tissue reaction in manner of PLA resorbable interference screws. It also has mechanical properties that are similar to bone, making it more biocompatible than metal.

Non-resorbables include devices made of metallic materials, of which titanium is the most commonly used. Historically, most devices were made from metal; however, since the introduction of more biocompatible materials, the use of metal interference screws has been steadily declining.

There are several different graft options that can be used for anterior cruciate ligament/posterior cruciate ligament (ACL/PCL) reconstruction procedures. One of the most traditional methods is the use of bone-to-bone (BTB) grafts, where the ends of the graft contain bone that is then fixed to the femoral and tibial tunnels. The other option for surgeons is to use soft tissue grafts (either hamstring or quadriceps tendon) that require the soft tissue to be fixed to the tibial and femoral bone. For procedures using BTB grafts, only interference screws are used for anchoring the tendon or ligament of the graft to the bone. In contrast, for procedures that use soft tissue grafts, a variety of other devices are available to fixate the graft to the femoral and tibial tunnels. For every ACL/PCL repair procedure, both the tibia and femur are involved in fixating the new tissue between these two bones. Fixation to the tibia differs from femoral fixation with respect to the devices used and thus the ACL/PCL fixation market is composed of the tibial fixation and femoral fixation segments.


EXECUTIVE SUMMARY
U.S. ORTHOPEDIC SOFT TISSUE REPAIR MARKET OVERVIEW
COMPETITIVE ANALYSIS
MARKET TRENDS
MARKET DEVELOPMENTS
PROCEDURE NUMBERS
PROCEDURE CODES INVESTIGATED
MARKETS INCLUDED
KEY REPORT UPDATES
VERSION HISTORY
RESEARCH METHODOLOGY
1.1 RESEARCH SCOPE
1.2 IDATA’S 9-STEP METHODOLOGY
Step 1: Project Initiation & Team Selection
Step 2: Prepare Data Systems and Perform Secondary Research
Step 3: Preparation for Interviews & Questionnaire Design
Step 4: Performing Primary Research
Step 5: Research Analysis: Establishing Baseline Estimates
Step 6: Market Forecast and Analysis
Step 7: Identify Strategic Opportunities
Step 8: Final Review and Market Release
Step 9: Customer Feedback and Market Monitoring
DISEASE OVERVIEW
2.1.1 Soft Tissue Injury
2.1.1.1 Sprains
2.1.1.2 Strains
2.1.1.3 Contusions
2.1.1.4 Tendinitis
2.1.1.5 Bursitis
2.1.2 Rotator Cuff Tears
2.1.3 Bicep Tendon Tear
2.1.4 ACL/PCL Injury
2.1.5 Meniscus Tears
2.1.6 Hip Injury
PRODUCT PORTFOLIOS
3.1.1 ACL/PCL Fixation
3.2 FDA RECALLS
3.2.1 Arthrex
3.2.2 DePuy Mitek
3.2.3 Smith & Nephew
3.2.4 Tornier
ACL/PCL FIXATION DEVICE MARKET
4.1 INTRODUCTION
4.2 MARKET OVERVIEW
4.3 MARKET ANALYSIS AND FORECAST
4.3.1 Total Femoral Fixation Device Market
4.3.2 Femoral Fixation Device Market by Segment
4.3.2.1 Total Femoral Interference Screw Market
4.3.2.2 Femoral Interference Screw Market by Segment
4.3.2.2.1 Femoral PLA Resorbable Interference Screw Market
4.3.2.2.2 Femoral Biocomposite Interference Screw Market
4.3.2.2.3 Femoral PEEK Interference Screw Market
4.3.2.2.4 Femoral Metal Interference Screw Market
4.3.2.3 Total Femoral Cross-Pin Market
4.3.2.4 Femoral Cross-Pin Market by Segment
4.3.2.4.1 Femoral Resorbable Cross-Pin Market
4.3.2.4.2 Femoral Non-Resorbable Cross-Pin Market
4.3.2.5 Femoral Intratunnel Fixation Device Market
4.3.2.6 Total Femoral Cortical Fixation Market
4.3.2.6.1 Femoral Cortical Fixation Device Market by Segment
4.3.3 Total Tibial Fixation Device Market
4.3.4 Tibial Fixation Device Market by Segment
4.3.4.1 Total Tibial Interference Screw Market
4.3.4.2 Tibial Interference Screw Market by Segment
4.3.4.2.1 Tibial PLA Resorbable Interference Screw Market
4.3.4.2.2 Tibial Biocomposite Interference Screw Market
4.3.4.2.3 Tibial PEEK Interference Screw Market
4.3.4.2.4 Tibial Metal Interference Screw Market
4.3.4.3 Tibial Intratunnel Fixation Device Market
4.3.4.4 Tibial Washer and Post Market
4.4 DRIVERS AND LIMITERS
4.4.1 Market Drivers
4.4.2 Market Limiters
4.5 COMPETITIVE MARKET SHARE ANALYSIS
ABBREVIATIONS
APPENDIX: COMPANY PRESS RELEASES
List of Charts
Chart 1 1: Orthopedic Soft Tissue Repair Market by Segment, U.S., 2013 – 2023
Chart 1 2: Orthopedic Soft Tissue Repair Market Overview, U.S., 2016 & 2023
Chart 4 1: ACL/PCL Fixation Market by Segment, U.S., 2013 – 2023
Chart 4 2: ACL/PCL Fixation Market Breakdown, U.S., 2016
Chart 4 3: ACL/PCL Fixation Market Breakdown, U.S., 2023
Chart 4 4: Total Femoral Fixation Device Market, U.S., 2013 – 2023
Chart 4 5: Femoral Fixation Device Market, U.S., 2013 – 2023
Chart 4 6: Total Femoral Interference Screw Market, U.S., 2013 – 2023
Chart 4 7: Femoral Interference Screw Market, U.S., 2013 – 2023
Chart 4 8: Femoral PLA Resorbable Interference Screw Market, U.S., 2013 – 2023
Chart 4 9: Femoral Biocomposite Interference Screw Market, U.S., 2013 – 2023
Chart 4 10: Femoral PEEK Interference Screw Market, U.S., 2013 – 2023
Chart 4 11: Femoral Metal Interference Screw Market, U.S., 2013 – 2023
Chart 4 12: Total Femoral Cross-Pin Market, U.S., 2013 – 2023
Chart 4 13: Femoral Cross-Pin Market by Segment, U.S., 2013 – 2023
Chart 4 14: Femoral Resorbable Cross-Pin Market, U.S., 2013 – 2023
Chart 4 15: Femoral Non-Resorbable Cross-Pin Market, U.S., 2013 – 2023
Chart 4 16: Femoral Intratunnel Fixation Device Market, U.S., 2013 – 2023
Chart 4 17: Total Femoral Cortical Fixation Market, U.S., 2013 – 2023
Chart 4 18: Femoral Cortical Fixation Device Market by Segment, U.S., 2013 – 2023
Chart 4 19: Fixed Loop Femoral Cortical Fixation Device Market, U.S., 2013 – 2023
Chart 4 20: Adjustable Loop Femoral Cortical Fixation Device Market, U.S., 2013 – 2023
Chart 4 21: Total Tibial Fixation Device Market, U.S., 2013 – 2023
Chart 4 22: Tibial Fixation Device Plasma Market by Segment, U.S., 2013 – 2023
Chart 4 23: Total Tibial Interference Screw Market, U.S., 2013 – 2023
Chart 4 24: Tibial Interference Screw Market by Segment, U.S., 2013 – 2023
Chart 4 25: Tibial PLA Resorbable Interference Screw Market, U.S., 2013 – 2023
Chart 4 26: Tibial Biocomposite Interference Screw Market, U.S., 2013 – 2023
Chart 4 27: Tibial PEEK Interference Screw Market, U.S., 2013 – 2023
Chart 4 28: Tibial Metal Interference Screw Market, U.S., 2013 – 2023
Chart 4 29: Tibial Intratunnel Fixation Device Market, U.S., 2013 – 2023
Chart 4 30: Tibial Washer and Post Market, U.S., 2013 – 2023
Chart 4 31: Leading Competitors, ACL/PCL Fixation Device Market, U.S., 2016
List of Figures
Figure 1 1: Orthopedic Soft Tissue Repair Market Share Ranking by Segment, U.S., 2016 (1 of 2)
Figure 1 2: Orthopedic Soft Tissue Repair Market Share Ranking by Segment, U.S., 2016 (2 of 2)
Figure 1 3: Companies Researched in this Report, U.S., 2016
Figure 1 4: Factors Impacting the Orthopedic Soft Tissue Repair Market by Segment, U.S. (1 of 2)
Figure 1 5: Factors Impacting the Orthopedic Soft Tissue Repair Market by Segment, U.S. (2 of 2)
Figure 1 6: Recent Events in the Orthopedic Soft Tissue Repair Market, U.S., 2014 – 2016
Figure 1 7: Orthopedic Soft Tissue Repair Markets Covered, U.S., 2016
Figure 1 8: Procedure Codes Investigated, U.S., 2016
Figure 1 9: Orthopedic Soft Tissue Repair Markets Covered, U.S., 2016 (1 of 2)
Figure 1 10: Orthopedic Soft Tissue Repair Markets Covered, U.S., 2016 (2 of 2)
Figure 1 11: Key Report Updates
Figure 1 12: Version History
Figure 3 1: ACL/PCL Fixation Devices by Company
Figure 3 2: Class 2 Device Recall Arthrex
Figure 3 3: Class 2 Device Recall Depuy Mitek
Figure 3 4: Class 2 Device Recall Depuy Mitek
Figure 3 5: Class 2 Device Recall Smith & Nephew
Figure 3 6: Class 2 Device Recall Smith & Nephew
Figure 3 7: Class 2 Device Recall Tornier
Figure 4 1: ACL/PCL Fixation Device Market by Segment, U.S., 2013 – 2023 (US$M)
Figure 4 2: Total Femoral Fixation Device Market, U.S., 2013 – 2023
Figure 4 3: Femoral Fixation Device Market by Segment, U.S., 2013 – 2023 (US$M)
Figure 4 4: Total Femoral Interference Screw Market, U.S., 2013 – 2023
Figure 4 5: Femoral Interference Screw Plasma Market by Segment, U.S., 2013 – 2023 (US$M)
Figure 4 6: Femoral PLA Resorbable Interference Screw Market, U.S., 2013 – 2023
Figure 4 7: Femoral Biocomposite Interference Screw Market, U.S., 2013 – 2023
Figure 4 8: Femoral PEEK Interference Screw Market, U.S., 2013 – 2023
Figure 4 9: Femoral Metal Interference Screw Market, U.S., 2013 – 2023
Figure 4 10: Total Femoral Cross-Pin Market, U.S., 2013 – 2023
Figure 4 11: Femoral Cross-Pin Market by Segment, U.S., 2013 – 2023 (US$M)
Figure 4 12: Femoral Resorbable Cross-Pin Market, U.S., 2013 – 2023
Figure 4 13: Femoral Non-Resorbable Cross-Pin Market, U.S., 2013 – 2023
Figure 4 14: Femoral Intratunnel Fixation Device Market, U.S., 2013 – 2023
Figure 4 15: Total Femoral Cortical Fixation Market, U.S., 2013 – 2023
Figure 4 16: Femoral Cortical Fixation Device Market by Segment, U.S., 2013 – 2023 (US$M)
Figure 4 17: Fixed Loop Femoral Cortical Fixation Device Market, U.S., 2013 – 2023
Figure 4 18: Adjustable Loop Femoral Cortical Fixation Device Market, U.S., 2013 – 2023
Figure 4 19: Total Tibial Fixation Device Market, U.S., 2013 – 2023
Figure 4 20: Tibial Fixation Device Market by Segment, U.S., 2013 – 2023 (US$M)
Figure 4 21: Total Tibial Interference Screw Market, U.S., 2013 – 2023
Figure 4 22: Tibial Interference Screw Market by Segment, U.S., 2013 – 2023 (US$M)
Figure 4 23: Tibial PLA Resorbable Interference Screw Market, U.S., 2013 – 2023
Figure 4 24: Tibial Biocomposite Interference Screw Market, U.S., 2013 – 2023
Figure 4 25: Tibial PEEK Interference Screw Market, U.S., 2013 – 2023
Figure 4 26: Tibial Metal Interference Screw Market, U.S., 2013 – 2023
Figure 4 27: Tibial Intratunnel Fixation Device Market, U.S., 2013 – 2023
Figure 4 28: Tibial Washer and Post Market, U.S., 2013 – 2023
Figure 4 29: Drivers and Limiters, ACL/PCL Fixation Device Market, U.S., 2016
Figure 4 30: Leading Competitors, ACL/PCL Fixation Device Market, U.S., 2016
Figure 6 1: Press Release Summary

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