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510(k) K243574

Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique by Microport Orthopedics, Inc. — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 18, 2025
Date Received
November 19, 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 Microport Orthopedics, Inc.

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  • K240043 — EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Fe (April 1, 2024)
  • K233507 — EVOLUTION® Tibial Cones (January 18, 2024)
  • K231947 — EVOLUTION® Cement Keel (October 31, 2023)
  • K230563 — EVOLUTION® Hinge Knee System (September 27, 2023)
  • K213817 — MPO Knee Instruments; MPO PROPHECY Knee Instruments (January 5, 2022)
  • K213816 — MPO Hip Instruments (January 5, 2022)
  • K200011 — E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS (October 1, 2021)

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  • 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)
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