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., Osteonic Co., Ltd. and Conmed Corporation.
List of Fastener, Fixation, Biodegradable, Soft Tissue devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Fastener, Fixation, Biodegradable, Soft Tissue devices (product code MAI). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Orthopedic FDA review panel. Browse all Orthopedic devices →