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510(k) K230120

KeYi Total Knee System by Beijing Keyi Medical Device Technology Co., Ltd. — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 2024
Date Received
January 17, 2023
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 Beijing Keyi Medical Device Technology Co., Ltd.

  • K191826 — KeYi Total Hip System (May 14, 2020)
  • K190567 — KeYi Spinal Fixation System (May 8, 2019)
  • K162380 — Locking Plate System (May 2, 2017)

Other clearances for product code JWH

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  • 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)