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510(k) K251834

Persona Partial Knee by Zimmer Biomet — Product Code HSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2025
Date Received
June 16, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3520
Review Panel
OR
Submission Type

Other clearances by Zimmer Biomet

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  • K250834 — Zimmer Biomet Ceramic Heads (22.2mm diameter) (April 18, 2025)
  • K243293 — Zimmer® Persona® Personalized Knee System (December 20, 2024)

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  • K241260 — ACTIFY™ Unicondylar Knee System (December 6, 2024)
  • K242711 — JOURNEY II Unicompartmental Knee System (JOURNEY II UK) (October 30, 2024)
  • K242746 — OvertureTi Knee Resurfacing SystemTM (October 7, 2024)
  • K232114 — TRIBRID® Unicompartmental Knee System (April 4, 2024)
  • K221292 — Uni Knee Resurfacing System (March 10, 2023)
  • K212870 — TLC Unicompartmental Knee System (June 16, 2022)
  • K220930 — Restoris Multi-Compartmental Knee System (June 2, 2022)