FDA Product Code MBF: Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented
Under FDA product code MBF, semi-constrained shoulder prostheses with metal and polymer bearing surfaces are cleared for hemiarthroplasty and total shoulder replacement.
These implants replace the humeral head with a metal component that articulates against a glenoid surface — either native bone in hemiarthroplasty or a polymer component in total shoulder replacement. They differ from reverse shoulder prostheses in preserving the anatomical ball-and-socket orientation.
MBF devices are Class II medical devices, regulated under 21 CFR 888.3670 and reviewed by the FDA Orthopedic panel.
Leading manufacturers include Zimmer, Inc., Lima Corporate S.P.A. and Depuy Ireland UC.
FDA 510(k) Cleared Prosthesis, Shoulder, Semi-constrained, Metal/polymer, Uncemented Devices (Product Code MBF)
About Product Code MBF - Regulatory Context
510(k) Submission Activity
37 total 510(k) submissions under product code MBF since 1985, with 37 receiving FDA clearance (average review time: 139 days).
Submission volume has declined in recent years - 4 submissions in the last 24 months compared to 9 in the prior period.
FDA Review Time
Recent submissions under MBF have taken an average of 112 days to reach a decision - down from 142 days historically, suggesting improved FDA processing for this classification.
MBF devices are reviewed by the Orthopedic panel. Browse all Orthopedic devices →