Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)— 510(k) K253592
Substantially EquivalentZimmer, Inc.
FDA 510(k) clearance K253592 for Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter), Substantially Equivalent on 2026-04-13. Applicant: Zimmer, Inc.. Device class: 2.
Summary
Zimmer's Zimmer Biomet Reverse Shoulder Prosthesis is filed under product code MBF (Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented). The name lists Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, and Comprehensive Reverse 32mm Glenospheres and Adapter.
Class II, 21 CFR 888.3670. Orthopedic is both the classification panel and the review panel. It came in as a Traditional 510(k).
Zimmer filed from Warsaw, Indiana. The record shows 147 calendar days from receipt to decision (November 17, 2025 to April 13, 2026).
Clearance details
- Applicant
- Zimmer, Inc.
- Product code
- Product code MBF
- Device class
- Class 2
- Regulation
- 21 CFR 888.3670
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warsaw, IN, US
Recent devices under product code MBF
view allMore clearances from Zimmer, Inc.
view allAdverse events under product code MBF
product code MBF- Injury
- 597
- Total
- 597
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.