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 OSSIO , Ltd..
FDA 510(k) Cleared Fastener, Fixation, Biodegradable, Soft Tissue Devices (Product Code MAI)
About Product Code MAI - Regulatory Context
510(k) Submission Activity
219 total 510(k) submissions under product code MAI since 1994, with 219 receiving FDA clearance (average review time: 108 days).
Submission volume has remained relatively stable over the observed period, with 15 submissions in the last 24 months.
FDA Review Time
Recent submissions under MAI have taken an average of 83 days to reach a decision - down from 110 days historically, suggesting improved FDA processing for this classification.
MAI devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →