Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)— 510(k) K253592

Name: FDA 510(k) clearance K253592
Creator: U.S. Food and Drug Administration
Published: 2026-04-13

Substantially Equivalent

Zimmer, 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.

Clearance details

Applicant: Zimmer, Inc.
Product code: Code MBF
Device class: Class 2
Regulation: 21 CFR 888.3670
Advisory panel: Orthopedic
Date received: 2025-11-17
Decision date: 2026-04-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MBF

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K251098 — Identity Revision Humeral Stems2025-08-11
K250848 — Identity Shoulder System2025-07-02
K240876 — Identity Shoulder System2024-06-12
K233712 — PRIMA Humeral System; PRIMA TT Glenoid2024-01-11
K231099 — SMR Hybrid Glenoid System2023-12-21

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Adverse events under product code MBF

product code MBF

Injury: 597
Total: 597

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.