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510(k) K232114

TRIBRID® Unicompartmental Knee System by Kyocera Medical Technologies, Inc. — Product Code HSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 2024
Date Received
July 14, 2023
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 Kyocera Medical Technologies, Inc.

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  • K212980 — Tesera-k ALIF System (January 7, 2022)
  • K212070 — KMTI S141 Lumbar Interbody Fusion System (August 30, 2021)
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Other clearances for product code HSX

  • K251771 — Cambridge Partial Knee (December 16, 2025)
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  • K251618 — MOTO Partial Knee System Extension (July 24, 2025)
  • K251453 — Arthrex iBalance Partial Knee System (July 1, 2025)
  • 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)
  • 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)