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..
FDA 510(k) Cleared Fastener, Fixation, Nondegradable, Soft Tissue Devices (Product Code MBI)
About Product Code MBI - Regulatory Context
510(k) Submission Activity
591 total 510(k) submissions under product code MBI since 1995, with 591 receiving FDA clearance (average review time: 100 days).
Submission volume has declined in recent years - 55 submissions in the last 24 months compared to 79 in the prior period.
FDA Review Time
Recent submissions under MBI have taken an average of 83 days to reach a decision - down from 102 days historically, suggesting improved FDA processing for this classification.
MBI devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →