Clearance Summary
BioBrace® Extra-Articular Ligament Augmentation Kit received FDA 510(k) clearance under submission number K252946, sponsored by Conmed Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2025-10-15.
- Submission: K252946
- Applicant / Sponsor: Conmed Corporation
- Clearance pathway: Special
- Review panel: Orthopedic
- Device class: Class II
- Regulation citation: 21 CFR 888.3030
- Decision date: 2025-10-15
Classification & Regulation
This clearance is catalogued under FDA product code MAI and 21 CFR 888.3030, within the Orthopedic review panel as a Class II device.