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510(k) K241873

OsseoFit Stemless Shoulder System by Zimmer, Inc. — Product Code PKC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 11, 2024
Date Received
June 27, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained
Device Class
Class II
Regulation Number
888.3660
Review Panel
OR
Submission Type

Replacement of the humeral head for total anatomic shoulder arthroplasty

Other clearances by Zimmer, Inc.

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  • K253189 — Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) (March 9, 2026)
  • 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)
  • K242543 — Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs) (November 22, 2024)
  • K243247 — Persona the Personalized Knee System (October 29, 2024)

Other clearances for product code PKC

  • K252129 — AETOS Shoulder System Stemless Humeral Prosthesis (October 3, 2025)
  • K243248 — INHANCE INTACT™ (December 23, 2024)
  • K240716 — AETOS Shoulder System Stemless Humeral Prosthesis (November 20, 2024)
  • K221758 — SMR Stemless Anatomic (March 17, 2023)
  • K220418 — Tornier Perform Humeral System – Stemless (September 14, 2022)
  • K213615 — Shoulder Innovations Total Shoulder System (March 11, 2022)
  • K212683 — GLOBAL ICON Stemless Shoulder System (January 19, 2022)
  • K203108 — Ignite Stemless Anatomic Shoulder System (July 16, 2021)
  • K201391 — Easytech® Anatomical Shoulder System (February 16, 2021)
  • K203100 — Arthrex Eclipse Titanium Humeral Head (November 20, 2020)