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FDA 510(k)

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

K-Number: K253592 · 2026-04-13

ApplicantZimmer, Inc.
Decision Date2026-04-13
Product CodeMBF
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) is a medical device manufactured by Zimmer, Inc.. It received FDA 510(k) clearance on 2026-04-13 under approval number K253592. The device is classified under product code MBF. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)?

Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) is a medical device that received FDA 510(k) clearance on 2026-04-13. It is manufactured by Zimmer, Inc.. The 510(k) number is K253592.

When was Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) approved by the FDA?

Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) received FDA 510(k) clearance on 2026-04-13, under approval number K253592.

What company makes Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)?

Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) is manufactured by Zimmer, Inc..

What is the FDA product code for Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)?

The FDA product code for Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter) is MBF.

Related Clinical Trials

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Other Devices by Zimmer, Inc.

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Related Devices (Code: MBF)

K163397SMR Hybrid Glenoid SystemLima Corporate S.P.A. K162068ARROW Anatomical Porous glenoidFournitures Hospitalieres Industrie K173824Humeral Short Stem SystemShoulder Innovations, Inc. K191963SMR Finned Short StemsLima Corporate S.P.A. K183553Compress and Mini Compress Anti-Rotation SpindlesBiomet, Inc. K201905SMR 140° Reverse Humeral BodyLima Corporate S.P.A.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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