FDA Clearance for Expanded Indications of BioBrace® Implant

  • Published: 4/28/2025
  • 4 min
CONMED is pleased to announce that the BioBrace® Implant has received FDA clearance for expanded indications, including the repair of extra-articular ligaments. This clearance also allows for performance claims of bioinductivity, clinically relevant strengthening, and similar stiffness to human tendons and ligaments.1

Expanded Indications

The FDA clearance now includes the repair of extra-articular ligaments, enhancing the versatility of BioBrace® in surgical applications. This expanded indication is a significant milestone, allowing surgeons to utilize BioBrace® for a broader range of ligament repairs.

BioBrace® has significantly improved tendon thickness and graft volume in preclinical studies. For instance, it has shown a 42% increase in ACL graft volume and a 180% increase in rotator cuff tendon thickness.2 These enhancements contribute to more effective and durable repairs, supporting better patient outcomes.

Performance Claims

CONMED has also earned the ability to use the terms 'bioinductive' and 'bio inductivity' in relation to BioBrace®. This achievement is backed by a robust scientific body of evidence presented by experts, including Robert Poggie, Andy Carter, Bill Walsh, and the New Haven CONMED team. BioBrace® demonstrates clinically relevant strengthening of repairs and similar stiffness to human tendons and ligaments, optimizing healing and patient outcomes.
BioBrace® facilitates new tissue growth that combines mechanical integrity with the natural healing process, boosting material strength. This process is crucial for achieving native tendon strength within 12 weeks of augmentation. The implant's ability to resorb naturally over time ensures that the newly formed tissue is strong and healthy, reducing re-injury risk.

BioBrace® can be leveraged in over 50 orthopedic procedures, demonstrating its versatility and effectiveness. Some key procedures include:

Rotator Cuff Repair

BioBrace® reinforces rotator cuff repairs, reducing re-tear rates and supporting tissue regeneration.1,2

ACL Reconstruction

BioBrace® enhances ACL graft volume and strength, optimizing the healing process and improving patient outcomes.

Patellar Tendon Repair

BioBrace® reinforces patellar tendon repairs, providing supplemental strength and promoting tissue regeneration.

Medial and Lateral Collateral Ligament Repairs

BioBrace® is effective in reinforcing MCL and LCL repairs, supporting the healing process and improving structural integrity.

Achilles Tendon Repair

BioBrace® supports the repair of Achilles tendon ruptures, facilitating rapid healing and reducing the risk of re-injury.

Ulnar Collateral Ligament Repair

BioBrace® enhances UCL repairs, providing mechanical strength and promoting new tissue growth.

BioBrace® offers key benefits that make it ideal for soft tissue reinforcement:

Added Strength
BioBrace® provides supplemental strength to the repaired tissue, reducing strain on injured areas and supporting healing.

Encourages Healing
Its unique design promotes the growth of new, healthy tissue, facilitating faster and more effective recovery.

Natural Absorption
The implant provides strength for two years, leaving behind healthy, regenerated tissue.

Versatility
BioBrace® can be used in a wide range of procedures.

Improved Patient Outcomes
By supporting tissue regeneration and providing mechanical strength, BioBrace® helps patients return to normal activities more quickly and with less risk of re-injury.

Technical Information

BioBrace® is designed for use in surgical procedures to reinforce soft tissue where weakness exists. It is intended for reinforcing soft tissues repaired by sutures or other fixation devices during tendon and ligament repair surgeries. This includes reinforcing the rotator cuff, patellar, Achilles, biceps, and quadriceps tendon, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament, and other tendons or extra-articular ligaments.3

BioBrace® is not intended to replace normal body structure or provide full mechanical strength to support these tissues. Instead, sutures and other fixation devices used to attach the tissue to the bone provide the necessary mechanical strength for the repair.4

BioBrace® is a versatile soft tissue augmentation solution that boosts tissue by combining biocomposite material with mechanical integrity in the natural healing process. It features a highly porous type-1 collagen matrix reinforced with bioresorbable PLLA microfilaments.1 This unique architecture facilitates rapid cellular infiltration and new tissue regeneration, optimizing the healing process.2

The implant supports tissue for approximately two years before naturally resorbing, providing supplemental strength through load sharing.1,2 BioBrace® is designed for both open and arthroscopic procedures, offering robust suture compatibility and handling characteristics. It rapidly absorbs 300% of its weight in blood or other fluids, enhancing its effectiveness in surgical applications.

Peer-reviewed literature supports its benefits, showing significant tendon thickness and graft volume improvements.3,4 These studies highlight the implant's ability to optimize healing and strengthen repairs, making it a valuable tool for surgeons.

Conclusion

The FDA clearance for expanded indications and performance claims marks a significant advancement for BioBrace®. Surgeons can now leverage BioBrace® for a broader range of procedures, ensuring reinforced repairs and improved healing.

Learn More

1 K203267, K242187 – 510(k) Clearance Letter - The BioBrace® Implant.
2 Based on preclinical animal data.
3 https://www.conmed.com/en/landing-pages/biobrace
4 https://www.conmed.com/-/media/conmed/documents/literature/biobrace_compendium.ashx