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510(k) K182125

EVOLUTION Stemmed CS Femur by Microport Orthopedics, Inc. — Product Code JWH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 2018
Date Received
August 6, 2018
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.

  • K250444 — NEXUS® Hip Stem (May 15, 2025)
  • K243574 — Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Techniqu (February 18, 2025)
  • K240046 — Ethylene Oxide Sterilization Supplier Change for MPO Hips (April 18, 2024)
  • K240452 — Ceramic Femoral Head (April 12, 2024)
  • 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)

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)