Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Microport Orthopedics, Inc. · Predicate Candidate Screening
37 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
110 daysmedian FDA review time
222 days90th percentile
37clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K250444 | NEXUS® Hip Stem | Microport Orthopedics, Inc. | 2025-05-15 | 90 | 0 |
| K243574 | Evolution® Total Knee Systems - Kinematic Alignment Instrume | Microport Orthopedics, Inc. | 2025-02-18 | 91 | 0 |
| K240452 | Ceramic Femoral Head | Microport Orthopedics, Inc. | 2024-04-12 | 57 | 0 |
| K240043 | EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;D | Microport Orthopedics, Inc. | 2024-04-01 | 87 | 0 |
| K233507 | EVOLUTION® Tibial Cones | Microport Orthopedics, Inc. | 2024-01-18 | 79 | 0 |
| K231947 | EVOLUTION® Cement Keel | Microport Orthopedics, Inc. | 2023-10-31 | 123 | 0 |
| K230563 | EVOLUTION® Hinge Knee System | Microport Orthopedics, Inc. | 2023-09-27 | 210 | 0 |
| K213817 | MPO Knee Instruments; MPO PROPHECY Knee Instruments | Microport Orthopedics, Inc. | 2022-01-05 | 29 | 0 |
| K213816 | MPO Hip Instruments | Microport Orthopedics, Inc. | 2022-01-05 | 29 | 0 |
| K200011 | E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LI | Microport Orthopedics, Inc. | 2021-10-01 | 638 | 0 |
| K201157 | Prime BIOFOAM® Multi-Hole Shells | Microport Orthopedics, Inc. | 2021-08-24 | 481 | 0 |
| K202705 | Prime and DYNASTY® Additive Manufacturing Shells | Microport Orthopedics, Inc. | 2021-08-20 | 338 | 0 |
| K201519 | PROFEMUR® GLADIATOR® Cemented Classic Stem | Microport Orthopedics, Inc. | 2020-12-10 | 185 | 0 |
| K200007 | PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar | Microport Orthopedics, Inc. | 2020-04-25 | 114 | 0 |
| K191632 | PROFEMUR TL2 Stems | Microport Orthopedics, Inc. | 2019-10-07 | 110 | 0 |
| K190123 | MicroPort CoCr Femoral Heads | Microport Orthopedics, Inc. | 2019-07-15 | 171 | 0 |
| K182125 | EVOLUTION Stemmed CS Femur | Microport Orthopedics, Inc. | 2018-12-06 | 122 | 0 |
| K181598 | Prime E-CLASS XLPE Liner | Microport Orthopedics, Inc. | 2018-09-14 | 88 | 0 |
| K180798 | Prime Acetabular Cup System | Microport Orthopedics, Inc. | 2018-07-09 | 104 | 0 |
| K173776 | BIOLOX delta Option and Extra-long Heads | Microport Orthopedics, Inc. | 2018-07-06 | 206 | 0 |
| K180317 | EVOLUTION® Knee Systems – MR Labeling, EVOLUTION® BIOFOAM® T | Microport Orthopedics, Inc. | 2018-05-04 | 88 | 0 |
| K171181 | PROCOTYL® PRIME E-CLASS™ XLPE Liner | Microport Orthopedics, Inc. | 2017-08-28 | 126 | 0 |
| K171389 | EVOLUTION Revision CCK System | Microport Orthopedics, Inc. | 2017-08-08 | 89 | 0 |
| K170444 | PROCOTYL® PRIME Acetabular Cup System | Microport Orthopedics, Inc. | 2017-06-26 | 132 | 0 |
| K170288 | BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOF | Microport Orthopedics, Inc. | 2017-06-15 | 136 | 0 |
| K162026 | EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Bl | Microport Orthopedics, Inc. | 2017-03-01 | 222 | 0 |
| K152631 | MPO Total Knee Systems MR Labeling | Microport Orthopedics, Inc. | 2016-03-23 | 190 | 0 |
| K152298 | EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVA | Microport Orthopedics, Inc. | 2015-11-16 | 95 | 0 |
| K150133 | PROFEMUR Preserve Size 1-3 Hip Stems | Microport Orthopedics, Inc. | 2015-04-20 | 89 | 0 |
| K150302 | PROFEMUR Preserve Classic Stem | Microport Orthopedics, Inc. | 2015-04-10 | 63 | 0 |
| K142119 | PROCOTYL L-O ACETABULAR SYSTEM | Microport Orthopedics, Inc. | 2015-02-27 | 207 | 0 |
| K143366 | ADVANCE Porous Coated Spiked Tibial Base | Microport Orthopedics, Inc. | 2015-01-21 | 58 | 0 |
| K142550 | EVOLUTION MP Revision Femur, EVOLUTION Femoral Augments | Microport Orthopedics, Inc. | 2014-11-07 | 58 | 0 |
| K141235 | PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS | Microport Orthopedics, Inc. | 2014-09-12 | 122 | 0 |
| K140735 | EVOLUTION MP CS/CR POROUS FEMUR/EVOLUTION ADAPTIVE CS AND PS | Microport Orthopedics, Inc. | 2014-08-29 | 158 | 1 |
| K140676 | PROFEMUR TL CLASSIC LONG NECK HIP STEMS | Microport Orthopedics, Inc. | 2014-05-30 | 73 | 0 |
| K140043 | DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLO | Microport Orthopedics, Inc. | 2014-04-03 | 85 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda