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 Lima Corporate S.P.A., Zimmer, Inc. and Biomet, Inc..