Cleared Special

BioBrace? Extra-Articular Ligament Augmentation Kit

K252946 · Conmed Corporation · Orthopedic

Oct 2025

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K252946 is an FDA 510(k) clearance for the BioBrace? Extra-Articular Ligament Augmentation Kit, a Fastener, Fixation, Biodegradable, Soft Tissue (Class II — Special Controls, product code MAI), submitted by Conmed Corporation (Utica, US). The FDA issued a Cleared decision on October 15, 2025, 30 days after receiving the submission on September 15, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.

Submission Details

510(k) Number	K252946 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 15, 2025
Decision Date	October 15, 2025
Days to Decision	30 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF