Company · US
Microport Orthopedics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2026. Name variants (Inc, Corp, punctuation) are merged.
40510(k) clearances (2 in 12 months)
33recalls (1 in 12 months)
31recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | 21 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | 20 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 7 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | 6 |
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | 4 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | 4 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 3 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | 2 |
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | 2 |
| HWC | Screw, Fixation, Bone | 1 |
| LXH | Orthopedic Manual Surgical Instrument | 1 |
| N/A | 1 | |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 1, 2026 | K262473 | NEXUS® Hip Stem Microport Orthopedics, Inc. | LZO |
| Aug 21, 2026 | K253728 | EVOLUTION® AM BIOFOAM® Tibial System Microport Orthopedics, Inc. | MBH |
| May 15, 2025 | K250444 | NEXUS® Hip Stem Microport Orthopedics, Inc. | LZO |
| Feb 18, 2025 | K243574 | Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique Microport Orthopedics, Inc. | JWH |
| Apr 18, 2024 | K240046 | Ethylene Oxide Sterilization Supplier Change for MPO Hips Microport Orthopedics | LPH |
| Apr 12, 2024 | K240452 | Ceramic Femoral Head Microport Orthopedics, Inc. | LZO |
| Apr 1, 2024 | K240043 | EVOLUTION® Hinge Knee System;GUARDIAN limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS Limb Salvage Sy Microport Orthopedics, Inc. | KRO |
| Jan 18, 2024 | K233507 | EVOLUTION® Tibial Cones Microport Orthopedics, Inc. | MBH |
| Oct 31, 2023 | K231947 | EVOLUTION® Cement Keel Microport Orthopedics, Inc. | JWH |
| Sep 27, 2023 | K230563 | EVOLUTION® Hinge Knee System Microport Orthopedics, Inc. | KRO |
| Jan 5, 2022 | K213817 | MPO Knee Instruments; MPO PROPHECY Knee Instruments Microport Orthopedics, Inc. | MBH |
| Jan 5, 2022 | K213816 | MPO Hip Instruments Microport Orthopedics, Inc. | JDI |
| Oct 1, 2021 | K200011 | E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS Microport Orthopedics, Inc. | LPH |
| Aug 24, 2021 | K201157 | Prime BIOFOAM® Multi-Hole Shells Microport Orthopedics, Inc. | MBL |
| Aug 20, 2021 | K202705 | Prime and DYNASTY® Additive Manufacturing Shells Microport Orthopedics, Inc. | OQG |
| Dec 10, 2020 | K201519 | PROFEMUR® GLADIATOR® Cemented Classic Stem Microport Orthopedics, Inc. | JDI |
| Apr 25, 2020 | K200007 | PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar Microport Orthopedics, Inc. | LZO |
| Oct 7, 2019 | K191632 | PROFEMUR TL2 Stems Microport Orthopedics, Inc. | LZO |
| Jul 15, 2019 | K190123 | MicroPort CoCr Femoral Heads Microport Orthopedics, Inc. | LPH |
| Dec 6, 2018 | K182125 | EVOLUTION Stemmed CS Femur Microport Orthopedics, Inc. | JWH |
| Sep 14, 2018 | K181598 | Prime E-CLASS XLPE Liner Microport Orthopedics, Inc. | LZO |
| Jul 9, 2018 | K180798 | Prime Acetabular Cup System Microport Orthopedics, Inc. | LPH |
| Jul 6, 2018 | K173776 | BIOLOX delta Option and Extra-long Heads Microport Orthopedics, Inc. | LZO |
| May 4, 2018 | K180317 | EVOLUTION® Knee Systems MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System, EVOLUTION® Microport Orthopedics, Inc. | MBH |
| Aug 28, 2017 | K171181 | PROCOTYL® PRIME E-CLASS XLPE Liner Microport Orthopedics, Inc. | LZO |
| Aug 8, 2017 | K171389 | EVOLUTION Revision CCK System Microport Orthopedics, Inc. | JWH |
| Jun 26, 2017 | K170444 | PROCOTYL® PRIME Acetabular Cup System Microport Orthopedics, Inc. | LPH |
| Jun 15, 2017 | K170288 | BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® Microport Orthopedics, Inc. | MBH |
| Mar 1, 2017 | K162026 | EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Rev Microport Orthopedics, Inc. | JWH |
| Mar 23, 2016 | K152631 | MPO Total Knee Systems MR Labeling Microport Orthopedics, Inc. | HRY |
| Nov 16, 2015 | K152298 | EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOF Microport Orthopedics, Inc. | MBH |
| Apr 20, 2015 | K150133 | PROFEMUR Preserve Size 1-3 Hip Stems Microport Orthopedics, Inc. | LZO |
| Apr 10, 2015 | K150302 | PROFEMUR Preserve Classic Stem Microport Orthopedics, Inc. | LZO |
| Feb 27, 2015 | K142119 | PROCOTYL L-O ACETABULAR SYSTEM Microport Orthopedics, Inc. | LPH |
| Jan 21, 2015 | K143366 | ADVANCE Porous Coated Spiked Tibial Base Microport Orthopedics, Inc. | MBH |
| Nov 7, 2014 | K142550 | EVOLUTION MP Revision Femur, EVOLUTION Femoral Augments Microport Orthopedics, Inc. | JWH |
| Sep 12, 2014 | K141235 | PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS Microport Orthopedics, Inc. | LZO |
| Aug 29, 2014 | K140735 | EVOLUTION MP CS/CR POROUS FEMUR/EVOLUTION ADAPTIVE CS AND PS INSERTS Microport Orthopedics, Inc. | MBH |
| May 30, 2014 | K140676 | PROFEMUR TL CLASSIC LONG NECK HIP STEMS Microport Orthopedics, Inc. | LZO |
| Apr 3, 2014 | K140043 | DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD Microport Orthopedics, Inc. | LZO |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 20, 2026 | MicroPort Orthopedics Inc. Brand Name: MicroPort
Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE
Model/Catalog Number: HTHT0036
Software Version: N/A
Product Description: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Open, Classified |
N/A | None listed |
| Dec 18, 2024 | MicroPort Orthopedics Inc. EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR;
EVOLUTION MP FEMORAL COMPONENT CS/CR NON-POROUS SIZE 6 LEFT PRIMARY, REF: EFSRN6PL
Knee prosthesis component Open, Classified |
MBH | K093552 K102380 +1 |
| Jul 1, 2024 | MicroPort Orthopedics Inc. EVOLUTION MP Femoral CS/CR Non-Porous
Non-porous MicroPort total knee replacement implants are for cemented use only. Open, Classified |
HRY | K093552 K102380 |
| Nov 22, 2022 | MicroPort Orthopedics Inc. EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base Terminated |
HRY | K093552 K102380 |
| Nov 22, 2022 | MicroPort Orthopedics Inc. EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base Terminated |
HRY | K093552 K102380 |
| May 4, 2022 | MicroPort Orthopedics Inc. PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK Terminated |
JDI | K123434 |
| Sep 18, 2020 | MicroPort Orthopedics Inc. PROFEMUR Neck Extra Long Titanium, Catalog Numbers: PHA01206, PHA01236, PHA01256. Hip prosthesis component Terminated |
LWJ | K003016 |
| Sep 18, 2020 | MicroPort Orthopedics Inc. PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip prosthesis component. Terminated |
LWJ | K003016 |
| Sep 9, 2020 | MicroPort Orthopedics Inc. PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descriptions:
Item Number Description Description 2
PHAC1202 PROFEMUR NECK NEUTRAL SHORT COBALT CHROME
PHAC1204 PROFEMUR NECK NEUTRA Open, Classified |
LWJ | K003016 K091423 +1 |
| Sep 18, 2017 | MicroPort Orthopedics Inc. MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R
Product Usage:
MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain a Terminated |
HWC | K952296 |
| Jan 3, 2017 | MicroPort Orthopedics Inc. PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics, Arlington, TN
Instruments support the implantation of implants. Broach handles mate to the broach to allow for prep Terminated |
LZO | K012091 |
| Dec 1, 2016 | MicroPort Orthopedics Inc. Cobalt Chromium Heads
Transcend: 26000017, 26000018, 26000019, 26000020, 26000021, 26000022, 26000023, 26000024, 26000025, 26000026, 26000027, 26000028
Conserve:
38013800, 38013804, 38013835, 38 Terminated |
LZO | K100866 |
| Dec 1, 2016 | MicroPort Orthopedics Inc. Conserve Cups: REF 38BF3642, REF 38BF3642SP, REF 38BF3844, REF 38BF3844SP, REF 38BF4046, REF 38BF4046SP, REF 38BF4248, REF 38BF4248SP, REF 38BF4450, REF 38BF4450SP,
REF 38BF4652, REF 38BF4652SP, REF Terminated |
LZO | K100866 |
| Dec 1, 2016 | MicroPort Orthopedics Inc. Conserve Shells: REF 38021146, REF 38021148, REF 38021150, REF 38021152, REF 38021154, REF 38021156, REF 38021158, REF 38021160, REF 38021162, REF 38021164, REF 38023642, REF 38023646, REF 38023844, Terminated |
LZO | K100866 |
| Dec 1, 2016 | MicroPort Orthopedics Inc. Lineage Shell: REF 36693646, REF 36693848, REF 36694050, REF 36694252, REF 36694454, REF 36694656, REF 36694858, REF 36695060, REF 36695262, REF 36695464
For use with the conserve metal head Terminated |
LZO | K100866 |
| Dec 1, 2016 | MicroPort Orthopedics Inc. Procotyl (Rim- Lock) Liners:
REF PHA04702, REF PHA04704, REF PHA04706, REF PHA04708, REF PHA04710, REF PHA04712, REF PHA04714
For use with the conserve metal head Terminated |
LZO | K100866 |
| Dec 1, 2016 | MicroPort Orthopedics Inc. Dynasty Liners:
REF DLCOGA28, REF DLCOGB32, REF DLCOGC36, REF DLCOGD38, REF DLCOGE40, REF DLCOGF42, REF DLCOGG44, REF DLCOGH48, REF DLCOGJ52, REF DLCOGK56,
For use with the conserve metal head Terminated |
LZO | K100866 |
| Dec 1, 2016 | MicroPort Orthopedics Inc. Lineage Liners:
REF 70102846, REF 70202852, REF 70202852, REF 70302858, REF 70303258, REF 70402864, REF 70403264, REF 70403664
For use with the conserve metal head Terminated |
LZO | K100866 |
| Sep 8, 2016 | MicroPort Orthopedics Inc. ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA60, SIZE 6 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 6 FEMUR & SIZE 6 TIBIAL INSERT; CONTENTS, 1 EACH, ST Terminated |
MBH | K061223 |
| Sep 8, 2016 | MicroPort Orthopedics Inc. ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA51, SIZE 5+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 5 FEMUR & SIZE 5 TIBIAL INSERT; CONTENTS, 1 EACH, STERI Terminated |
MBH | K061223 |
| Sep 8, 2016 | MicroPort Orthopedics Inc. ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA50, SIZE 5 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 5 FEMUR & SIZE 5 TIBIAL INSERT; CONTENTS, 1 EACH, ST Terminated |
MBH | K061223 |
| Sep 8, 2016 | MicroPort Orthopedics Inc. ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA41, SIZE 4+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 4 FEMUR & SIZE 4 TIBIAL INSERT; CONTENTS, 1 EACH, STERI Terminated |
MBH | K061223 |
| Sep 8, 2016 | MicroPort Orthopedics Inc. ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA40, SIZE 4 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 4 FEMUR & SIZE 4 TIBIAL INSERT; CONTENTS, 1 EACH, ST Terminated |
MBH | K061223 |
| Sep 8, 2016 | MicroPort Orthopedics Inc. ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA31, SIZE 3+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 3 FEMUR & SIZE 3 TIBIAL INSERT; CONTENTS, 1 EACH, STERI Terminated |
MBH | K061223 |
| Sep 8, 2016 | MicroPort Orthopedics Inc. ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA30, SIZE 3 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 3 FEMUR & SIZE 3 TIBIAL INSERT; CONTENTS, 1 EACH, ST Terminated |
MBH | K061223 |
| Sep 8, 2016 | MicroPort Orthopedics Inc. ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA21, SIZE 2+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 2 FEMUR & SIZE 2 TIBIAL INSERT; CONTENTS, 1 EACH, STERI Terminated |
MBH | K061223 |
| Sep 8, 2016 | MicroPort Orthopedics Inc. ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA20, SIZE 2 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 2 FEMUR & SIZE 2 TIBIAL INSERT; CONTENTS, 1 EACH, ST Terminated |
MBH | K061223 |
| Sep 8, 2016 | MicroPort Orthopedics Inc. ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA11, SIZE 1+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 1 FEMUR & SIZE 1 TIBIAL INSERT; CONTENTS, 1 EACH, STERI Terminated |
MBH | K061223 |
| Sep 8, 2016 | MicroPort Orthopedics Inc. ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA10, SIZE 1 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 1 FEMUR & SIZE 1 TIBIAL INSERT; CONTENTS, 1 EACH, ST Terminated |
MBH | K061223 |
| Aug 18, 2016 | MicroPort Orthopedics Inc. PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature pati Terminated |
LWJ | K003016 |
| Sep 28, 2015 | MicroPort Orthopedics, Inc. PROFEMUR PLUS CoCr MODULAR NECK, REF: PHAC1254, SIZE LONG, ORIENTATION 8 degree VAR/VAL. 12/14 SLT Taper.
Orthopedic hip prosthesis component. Terminated |
MBL | K091423 K100866 |
| Mar 6, 2015 | Microport Orthopedics INC. EVOLUTION MP TIBIAL BASE, REF ETPKN8SR, SIZE 8 RIGHT, TYPE PRIMARY, FIT CEMENTED, STYLE KEELED, STERILE R, Rx ONLY, MicroPort Orthopedics, Inc. Knee prosthesis component. Terminated |
JWH | K093552 |
| Jun 4, 2014 | Microport Orthopedics INC. PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Orthopaedic surgical instrument. Terminated |
LXH | None listed |