MicroPort Orthopedics Inc.

FDA Regulatory Profile

Summary

Total Recalls
33 (14 Class I)
510(k) Clearances
38
Inspections
3
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-1133-2026Class IIBrand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHDecember 19, 2025
Z-0699-2025Class IIEVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMOctober 29, 2024
Z-2244-2024Class IIEVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are fMay 3, 2024
Z-0276-2023Class IIEVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial baseOctober 28, 2022
Z-0275-2023Class IIEVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial baseOctober 28, 2022
Z-1225-2022Class IIPROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECKMay 4, 2022
Z-2942-2020Class IPROFEMUR Neck Extra Long Titanium, Catalog Numbers: PHA01206, PHA01236, PHA01256. Hip prosthesis coJuly 31, 2020
Z-2948-2020Class IIPROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descriptions: Item Number DescrJuly 31, 2020
Z-2941-2020Class IPROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHAJuly 31, 2020
Z-0043-2018Class IIMicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: September 18, 2017
Z-0943-2017Class IIPROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics, Arlington, TN November 17, 2016
Z-2588-2016Class IIPROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intended for use in total hipJune 30, 2016
Z-2703-2016Class IADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA60, SIZE 6 STD; SURFACEJune 21, 2016
Z-0687-2017Class IIIConserve Shells: REF 38021146, REF 38021148, REF 38021150, REF 38021152, REF 38021154, REF 38021156June 21, 2016
Z-0685-2017Class IIIProcotyl (Rim- Lock) Liners: REF PHA04702, REF PHA04704, REF PHA04706, REF PHA04708, REF PHA04710, June 21, 2016
Z-2694-2016Class IADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA11, SIZE 1+; SURFACE POJune 21, 2016
Z-2699-2016Class IADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA40, SIZE 4 STD; SURFACEJune 21, 2016
Z-2698-2016Class IADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA31, SIZE 3+; SURFACE POJune 21, 2016
Z-2693-2016Class IADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA10, SIZE 1 STD; SURFACEJune 21, 2016
Z-2700-2016Class IADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA41, SIZE 4+; SURFACE POJune 21, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K250444NEXUS® Hip StemMay 15, 2025
K243574Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and TechniqueFebruary 18, 2025
K240046Ethylene Oxide Sterilization Supplier Change for MPO HipsApril 18, 2024
K240452Ceramic Femoral HeadApril 12, 2024
K240043EVOLUTION® Hinge Knee System;GUARDIAN™ limb Salvage System;DCW Modular Distal Femoral System;REPIPHYApril 1, 2024
K233507EVOLUTION® Tibial ConesJanuary 18, 2024
K231947EVOLUTION® Cement KeelOctober 31, 2023
K230563EVOLUTION® Hinge Knee SystemSeptember 27, 2023
K213816MPO Hip InstrumentsJanuary 5, 2022
K213817MPO Knee Instruments; MPO PROPHECY Knee InstrumentsJanuary 5, 2022
K200011E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERSOctober 1, 2021
K201157Prime BIOFOAM® Multi-Hole ShellsAugust 24, 2021
K202705Prime and DYNASTY® Additive Manufacturing ShellsAugust 20, 2021
K201519PROFEMUR® GLADIATOR® Cemented Classic StemDecember 10, 2020
K200007PROFEMUR GLADIATOR Thin HA Classic Hip Stem with CollarApril 25, 2020
K191632PROFEMUR TL2 StemsOctober 7, 2019
K190123MicroPort CoCr Femoral HeadsJuly 15, 2019
K182125EVOLUTION Stemmed CS FemurDecember 6, 2018
K181598Prime E-CLASS XLPE LinerSeptember 14, 2018
K180798Prime Acetabular Cup SystemJuly 9, 2018