Microport Orthopedics, Inc.
FDA 510(k) & PMA Approved Devices — 28 products
Total Devices28
Categories10
Latest FDA decision2025-05-15
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 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 |
No matching devices.
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