FDA Product Code MAI: Fastener, Fixation, Biodegradable, Soft Tissue

Biodegradable fixation eliminates the need for hardware removal surgery in soft tissue repair. FDA product code MAI covers biodegradable soft tissue fixation fasteners.

These implants anchor tendons and ligaments to bone during reconstructive procedures and gradually resorb as the tissue heals, leaving no permanent implant in the body. They are used in ACL reconstruction, rotator cuff repair, and other sports medicine procedures.

MAI devices are Class II medical devices, regulated under 21 CFR 888.3030 and reviewed by the FDA Orthopedic panel.

Leading manufacturers include Arthrex, Inc., Smith & Nephew, Inc. and Medos International SARL.