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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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 2026
Date Received
November 17, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Device Class
Class II
Regulation Number
888.3670
Review Panel
OR
Submission Type

Other clearances by Zimmer, Inc.

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  • K252623 — G7® Revision Acetabular System (February 4, 2026)
  • K251098 — Identity Revision Humeral Stems (August 11, 2025)
  • K251906 — Z1 Hip System (July 18, 2025)
  • K250848 — Identity Shoulder System (July 2, 2025)
  • K243724 — Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) (March 6, 2025)
  • K243907 — Affixus Tibial Nailing System - 4mm screws (February 12, 2025)
  • K241873 — OsseoFit Stemless Shoulder System (December 11, 2024)
  • K242543 — Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs) (November 22, 2024)

Other clearances for product code MBF

  • K251098 — Identity Revision Humeral Stems (August 11, 2025)
  • K250848 — Identity Shoulder System (July 2, 2025)
  • K240876 — Identity Shoulder System (June 12, 2024)
  • K233712 — PRIMA Humeral System; PRIMA TT Glenoid (January 11, 2024)
  • K231099 — SMR Hybrid Glenoid System (December 21, 2023)
  • K230831 — INHANCE Shoulder System Convertible Glenoid Inserts, INHANCE Convertible Glenoid (November 13, 2023)
  • K231516 — INHANCE™ Shoulder System, Sterile Single Use Instrumentation (July 21, 2023)
  • K223876 — SMR Shoulder System (February 3, 2023)
  • K222427 — PRIMA TT Glenoid (October 6, 2022)
  • K213856 — Identity Shoulder System (September 15, 2022)