Microport Orthopedics, Inc.
Microport Orthopedics, Inc. holds FDA 510(k) medical device clearances, first cleared 2014, most recent 2026, with 33 FDA device recalls on record.
Top product codes for Microport Orthopedics, Inc.
FDA recalls by Microport Orthopedics, Inc.
10 most recent of 33- Z-1133-2026 — 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
- Z-0699-2025 — 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
- Z-2244-2024 — EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.
- Z-0275-2023 — EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base
- Z-0276-2023 — EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base
- Z-1225-2022 — PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK
- Z-2948-2020 — 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 NEUTRAL LONG COBALT CHROME PHAC1212 PROFEMUR NECK A/R VAR/VAL 2 SHORT COBALT CHROME PHAC1214 PROFEMUR NECK A/R VAR/VAL 2 LONG COBALT CHROME PHAC1222 PROFEMUR NECK A/R VAR/VAL 1 SHORT COBALT CHROME PHAC1224 PROFEMUR NECK A/R VAR/VAL 1 LONG COBALT CHROME PHAC1232 PROFEMUR NECK A/R 8DG SHORT COBALT CHROME PHAC1234 PROFEMUR NECK A/R 8DG LONG COBALT CHROME PHAC1242 PROFEMUR NECK A/R 15DG SHORT COBALT CHROME PHAC1244 PROFEMUR NECK A/R 15DG LONG COBALT CHROME PHAC1252 PROFEMUR NECK VAR/VAL 8DG SHORT COBALT CHROME PHA01202 PROFEMUR NECK NEUTRALSHORT SHORT PHA01204 PROFEMUR NECK NEUTRAL LONG PHA01206 PROFEMUR NECK NEUTRAL X LONG PHA01212 PROFEMUR NECK A/R VAR/VAL 2 SHORT PHA01214 PROFEMUR NECK A/R VAR/VAL 2 LONG PHA01222 PROFEMUR NECK A/R VAR/VAL 1 SHORT PHA01224 PROFEMUR NECK A/R VAR/VAL 1 LONG PHA01232 PROFEMUR NECK 8DG A/R SHORT PHA01234 PROFEMUR NECK 8DG A/R LONG PHA01236 PROFEMUR NECK 8DG A/R X LONG PHA01242 PROFEMUR NECK 15DG A/R SHORT PHA01244 PROFEMUR NECK 15DG A/R LONG PHA01252 PROFEMUR NECK 8DG VAR/VAL SHORT PHA01254 PROFEMUR NECK 8DG VAR/VAL LONG PHA01256 PROFEMUR NECK 8DG VAR/VAL X LONG PHA01262 PROFEMUR NECK 15DG VAR/VAL SHORT PHA01264 PROFEMUR NECK 15DG VAR/VAL LONG Intended Use: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
- Z-2941-2020 — PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip prosthesis component.
- Z-2942-2020 — PROFEMUR Neck Extra Long Titanium, Catalog Numbers: PHA01206, PHA01236, PHA01256. Hip prosthesis component
- Z-0043-2018 — 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 and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Microport Orthopedics, Inc.
- K253728 — EVOLUTION® AM BIOFOAM® Tibial System
- K250444 — NEXUS® Hip Stem
- K243574 — Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique
- K240452 — Ceramic Femoral Head
- K240043 — EVOLUTION® Hinge Knee System +13 more
- K233507 — EVOLUTION® Tibial Cones
- K231947 — EVOLUTION® Cement Keel
- K230563 — EVOLUTION® Hinge Knee System
- K213816 — MPO Hip Instruments
- K213817 — MPO Knee Instruments; MPO PROPHECY Knee Instruments
- K200011 — E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS
- K201157 — Prime BIOFOAM® Multi-Hole Shells
- K202705 — Prime and DYNASTY® Additive Manufacturing Shells
- K201519 — PROFEMUR® GLADIATOR® Cemented Classic Stem
- K200007 — PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar
- K191632 — PROFEMUR TL2 Stems
- K190123 — MicroPort CoCr Femoral Heads
- K182125 — EVOLUTION Stemmed CS Femur
- K181598 — Prime E-CLASS XLPE Liner
- K180798 — Prime Acetabular Cup System
- K173776 — BIOLOX delta Option and Extra-long Heads
- K180317 — EVOLUTION® Knee Systems MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System, EVOLUTION® Revision CCK System
- K171181 — PROCOTYL® PRIME E-CLASS XLPE Liner
- K171389 — EVOLUTION Revision CCK System
- K170444 — PROCOTYL® PRIME Acetabular Cup System
- K170288 — BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell
- K162026 — EVOLUTION Revision Tibial Base, EVOLUTION Revision Tibial Block Augment, EVOLUTION Revision Modular Keels, EVOLUTION Revision Stem Adapters (offset and extension), EVOLUTION Revision Cemented Stem Extensions, Canal Filling Stem Extensions
- K152631 — MPO Total Knee Systems MR Labeling
- K152298 — EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM Tibial Base
- K150133 — PROFEMUR Preserve Size 1-3 Hip Stems
- K150302 — PROFEMUR Preserve Classic Stem
- K142119 — PROCOTYL L-O ACETABULAR SYSTEM
- K143366 — ADVANCE Porous Coated Spiked Tibial Base
- K142550 — EVOLUTION MP Revision Femur, EVOLUTION Femoral Augments
- K141235 — PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS
- K140735 — EVOLUTION MP CS/CR POROUS FEMUR/EVOLUTION ADAPTIVE CS AND PS INSERTS
- K140676 — PROFEMUR TL CLASSIC LONG NECK HIP STEMS
- K140043 — DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD
Data sourced from openFDA. This site is unofficial and independent of the FDA.