510(k) K253592

Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) by Zimmer, Inc. — Product Code MBF

K253592 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)". The FDA issued a decision of Substantially Equivalent on April 13, 2026. The device falls under product code MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented), a Class II device regulated under 21 CFR 888.3670. Zimmer, Inc. has at least 10 other 510(k) clearances on record.