FDA Product Code MBI: Fastener, Fixation, Nondegradable, Soft Tissue
FDA product code MBI covers nondegradable soft tissue fixation fasteners.
These orthopedic implants are used to anchor soft tissue — such as tendons and ligaments — to bone during reconstructive procedures. They are designed to remain permanently in the body without degrading over time.
MBI devices are Class II medical devices, regulated under 21 CFR 888.3040 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Arthrex, Inc., Riverpoint Medical and Paragon 28, Inc..
List of Fastener, Fixation, Nondegradable, Soft Tissue devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Fastener, Fixation, Nondegradable, Soft Tissue devices (product code MBI). 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 →