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510(k) K152631

MPO Total Knee Systems MR Labeling by Microport Orthopedics, Inc. — Product Code HRY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2016
Date Received
September 15, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
Device Class
Class II
Regulation Number
888.3530
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)

Other clearances for product code HRY

  • K193549 — SIGMA High Performance (HP) Partial Knee System (April 16, 2020)
  • K190633 — NanoOrtho NanoKnee® System (December 20, 2019)
  • K150410 — RESTORIS POROUS PARTIAL KNEE SYSTEM (March 20, 2015)
  • K133940 — OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS) (March 28, 2014)
  • K131167 — UNIVATION (October 17, 2013)
  • K122277 — OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (OXFORD TIBIAL TRAYS A-F) (October 22, 2012)
  • K110415 — SIGNATURE PLANNER / SIGNATURE GUIDES (May 16, 2011)
  • K100973 — EVOLUTION UNICONDYLAR KNEE SYSTEM (August 10, 2010)
  • K082567 — STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION (October 3, 2008)
  • K081293 — UNIVATION UNICONDYLAR KNEE SYSTEM (September 22, 2008)