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Microport Orthopedics, Inc.

FDA 510(k) & PMA Approved Devices — 28 products

Total Devices28
Categories10
Latest Approval2025-05-15
TypeNumberDevice NameCodeDate
510(k) K250444 NEXUS® Hip Stem LZO 2025-05-15 View
510(k) K243574 Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique JWH 2025-02-18 View
510(k) K240452 Ceramic Femoral Head LZO 2024-04-12 View
510(k) K240043 EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS™ Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse KRO 2024-04-01 View
510(k) K233507 EVOLUTION® Tibial Cones MBH 2024-01-18 View
510(k) K231947 EVOLUTION® Cement Keel JWH 2023-10-31 View
510(k) K230563 EVOLUTION® Hinge Knee System KRO 2023-09-27 View
510(k) K213817 MPO Knee Instruments; MPO PROPHECY Knee Instruments MBH 2022-01-05 View
510(k) K213816 MPO Hip Instruments JDI 2022-01-05 View
510(k) K200011 E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS LPH 2021-10-01 View
510(k) K201157 Prime BIOFOAM® Multi-Hole Shells MBL 2021-08-24 View
510(k) K202705 Prime and DYNASTY® Additive Manufacturing Shells OQG 2021-08-20 View
510(k) K201519 PROFEMUR® GLADIATOR® Cemented Classic Stem JDI 2020-12-10 View
510(k) K200007 PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar LZO 2020-04-25 View
510(k) K191632 PROFEMUR TL2 Stems LZO 2019-10-07 View
510(k) K190123 MicroPort CoCr Femoral Heads LPH 2019-07-15 View
510(k) K182125 EVOLUTION Stemmed CS Femur JWH 2018-12-06 View
510(k) K181598 Prime E-CLASS XLPE Liner LZO 2018-09-14 View
510(k) K180798 Prime Acetabular Cup System LPH 2018-07-09 View
510(k) K173776 BIOLOX delta Option and Extra-long Heads LZO 2018-07-06 View

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