510(k) K252946

BioBrace® Extra-Articular Ligament Augmentation Kit by Conmed Corporation — Product Code MAI

K252946 is an FDA 510(k) premarket notification submitted by Conmed Corporation for the device "BioBrace® Extra-Articular Ligament Augmentation Kit". The FDA issued a decision of Substantially Equivalent on October 15, 2025. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Conmed Corporation has at least 10 other 510(k) clearances on record.