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510(k) K251098

Identity Revision Humeral Stems by Zimmer, Inc. — Product Code MBF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 2025
Date Received
April 10, 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

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  • K243724 — Persona® Revision Knee System (Persona Revision SoluTion™ Femoral Components) (March 6, 2025)
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  • K241873 — OsseoFit Stemless Shoulder System (December 11, 2024)
  • K242543 — Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs) (November 22, 2024)
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Other clearances for product code MBF

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  • 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)
  • K212933 — INHANCETM Hybrid Anatomic Glenoid Implant (June 8, 2022)