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510(k) K243295

Initia Knee System by Kyocera Medical Technologies, Inc. — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2025
Date Received
October 18, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Device Class
Class II
Regulation Number
888.3560
Review Panel
OR
Submission Type

Other clearances by Kyocera Medical Technologies, Inc.

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  • K242045 — Initia T3 Acetabular Hemispherical Shell System (April 10, 2025)
  • K242771 — Tesera-k PL System and Tesera-k XL System (March 20, 2025)
  • K243015 — Skyway Anterior Cervical Plate System (November 5, 2024)
  • K232114 — TRIBRID® Unicompartmental Knee System (April 4, 2024)
  • K230808 — PEEK SA Anterior Lumbar Interbody Fusion (ALIF) System (April 21, 2023)
  • K223105 — Tesera-K SC System (December 22, 2022)
  • K212980 — Tesera-k ALIF System (January 7, 2022)
  • K212070 — KMTI S141 Lumbar Interbody Fusion System (August 30, 2021)
  • K203472 — KMTI Hip Replacement System (April 2, 2021)

Other clearances for product code JWH

  • K253793 — Materialise TKA Guide System (January 6, 2026)
  • K252974 — EMPOWR Knee (December 19, 2025)
  • K253197 — ATTUNE™ Total Knee System; ATTUNE™ Revision Sleeve LPS™ Femoral Adaptors (November 19, 2025)
  • K253314 — Freedom Infinia™ Total Knee System (October 29, 2025)
  • K253144 — Freedom® Total Knee System – Titan PCK Components (October 22, 2025)
  • K252725 — Stem Extension Line (U2 Total Knee System—PSA Type) (September 25, 2025)
  • K251554 — Materialise TKA Guide System (July 14, 2025)
  • K251776 — EMPOWR Revision Knee™ (EMPOWR Revision VVC+, e+ Tibial Insert) (July 8, 2025)
  • K251241 — EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) (July 2, 2025)
  • K251717 — Freedom® Total Knee System – Titanium Tibial Base Plate (June 26, 2025)