FDA Clearance for Expanded Indications of BioBrace® Implant
- Published: 4/28/2025
- 4 min
Performance Claims
BioBrace® can be leveraged in over 50 orthopedic procedures, demonstrating its versatility and effectiveness. Some key procedures include:
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 gradually dissolves over about 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 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.
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