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510(k) K230563

EVOLUTION® Hinge Knee System by Microport Orthopedics, Inc. — Product Code KRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2023
Date Received
March 1, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3510
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)
  • 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)

Other clearances for product code KRO

  • K252898 — Triathlon® Tritanium® Asymmetric Patella; Triathlon® Tritanium® Symmetric Patell (December 15, 2025)
  • K252303 — Stem Extension Line (USTAR II System) (August 22, 2025)
  • K251665 — Triathlon® Hinge Knee System (July 25, 2025)
  • K242871 — ATTUNE™ Revision Hinge Knee (November 21, 2024)
  • K240043 — EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Fe (April 1, 2024)
  • K233980 — ATTUNE Total Knee System, ATTUNE Cementless Knee System, LPS Limb Preservation S (March 21, 2024)
  • K230416 — Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® (May 19, 2023)
  • K223069 — Modular Rotating Hinge Knee Systems and Compatible Components (April 21, 2023)
  • K223528 — Triathlon® Hinge Knee System (January 20, 2023)
  • K220628 — LINK Endo-Model EVO Knee System (May 3, 2022)