Microport Orthopedics Inc.
Arlington, TN, US
MICROPORT ORTHOPEDICS INC. appears in FDA device records in Arlington, TN. FDA records list 38 510(k) clearances between and , 13 PMA records and 2 registered establishments. As of , FDA records show 33 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 38 510(k) clearances for Microport Orthopedics Inc. between 2014 and 2025. The busiest year on record is 2014, with 5. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2014 | 5 |
| 2015 | 5 |
| 2016 | 1 |
| 2017 | 5 |
| 2018 | 5 |
| 2019 | 2 |
| 2020 | 2 |
| 2021 | 3 |
| 2022 | 2 |
| 2023 | 2 |
| 2024 | 4 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250444 | NEXUS® Hip Stem | LZO | Substantially Equivalent | |
| K243574 | Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique | JWH | Substantially Equivalent | |
| K240046 | Ethylene Oxide Sterilization Supplier Change for MPO Hips | LPH | Substantially Equivalent | |
| K240452 | Ceramic Femoral Head | LZO | Substantially Equivalent | |
| 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 | Substantially Equivalent | |
| K233507 | EVOLUTION® Tibial Cones | MBH | Substantially Equivalent | |
| K231947 | EVOLUTION® Cement Keel | JWH | Substantially Equivalent | |
| K230563 | EVOLUTION® Hinge Knee System | KRO | Substantially Equivalent | |
| K213817 | MPO Knee Instruments; MPO PROPHECY Knee Instruments | MBH | Substantially Equivalent | |
| K213816 | MPO Hip Instruments | JDI | Substantially Equivalent | |
| K200011 | E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS | LPH | Substantially Equivalent | |
| K201157 | Prime BIOFOAM® Multi-Hole Shells | MBL | Substantially Equivalent | |
| K202705 | Prime and DYNASTY® Additive Manufacturing Shells | OQG | Substantially Equivalent | |
| K201519 | PROFEMUR® GLADIATOR® Cemented Classic Stem | JDI | Substantially Equivalent | |
| K200007 | PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar | LZO | Substantially Equivalent | |
| K191632 | PROFEMUR TL2 Stems | LZO | Substantially Equivalent | |
| K190123 | MicroPort CoCr Femoral Heads | LPH | Substantially Equivalent | |
| K182125 | EVOLUTION Stemmed CS Femur | JWH | Substantially Equivalent | |
| K181598 | Prime E-CLASS XLPE Liner | LZO | Substantially Equivalent | |
| K180798 | Prime Acetabular Cup System | LPH | Substantially Equivalent | |
| K173776 | BIOLOX delta Option and Extra-long Heads | LZO | Substantially Equivalent | |
| K180317 | EVOLUTION® Knee Systems – MR Labeling, EVOLUTION® BIOFOAM® Tibial System, EVOLUTION® Revision Tibial System, EVOLUTION® Revision CCK System | MBH | Substantially Equivalent | |
| K171181 | PROCOTYL® PRIME E-CLASS™ XLPE Liner | LZO | Substantially Equivalent | |
| K171389 | EVOLUTION Revision CCK System | JWH | Substantially Equivalent | |
| K170444 | PROCOTYL® PRIME Acetabular Cup System | LPH | Substantially Equivalent | |
| K170288 | BIOFOAM® Additive Manufacturing (BIOFOAM® AM), ADVANCE® BIOFOAM® Tibial Base, EVOLUTION® BIOFOAM® Tibial Base, DYNASTY® BIOFOAM® Acetabular Shell | MBH | Substantially Equivalent | |
| 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 | JWH | Substantially Equivalent | |
| K152631 | MPO Total Knee Systems MR Labeling | HRY | Substantially Equivalent | |
| K152298 | EVOLUTION BIOFOAM Tibial Base, EVOLUTION Modular Keels, ADVANCE Modular Keels, ADVANCE Bullet-Tipped Keels, ADVANCE BIOFOAM Tibial Base | MBH | Substantially Equivalent | |
| K150133 | PROFEMUR Preserve Size 1-3 Hip Stems | LZO | Substantially Equivalent | |
| K150302 | PROFEMUR Preserve Classic Stem | LZO | Substantially Equivalent | |
| K142119 | PROCOTYL L-O ACETABULAR SYSTEM | LPH | Substantially Equivalent | |
| K143366 | ADVANCE Porous Coated Spiked Tibial Base | MBH | Substantially Equivalent | |
| K142550 | EVOLUTION MP Revision Femur, EVOLUTION Femoral Augments | JWH | Substantially Equivalent | |
| K141235 | PROFEMUR RENAISSANCE CLASSIC LONG NECK HIP STEMS | LZO | Substantially Equivalent | |
| K140735 | EVOLUTION MP CS/CR POROUS FEMUR/EVOLUTION ADAPTIVE CS AND PS INSERTS | MBH | Substantially Equivalent | |
| K140676 | PROFEMUR TL CLASSIC LONG NECK HIP STEMS | LZO | Substantially Equivalent | |
| K140043 | DYNASTY SHELL, DYNASTY A-CLASS CROSSLINKED POLY LINER, BIOLOX DELTA FEMORAL HEAD | LZO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3010536692 | 3010536692 | MICROPORT ORTHOPEDICS INC. | 5677 AIRLINE RD, Arlington, TN 38002 US | 2026 | and 92 more, listed in full below |
| 3010856250 | 3010856250 | Microport Orthopedics, S.A. | Edificio Torre La Sabana, Piso 9, Sabana Norte San Jose 10108 CR | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HXNApplier, Cerclage
- HWJAwl
- HTWBit, Drill
- GFGBit, Surgical
- GFABlade, Saw, General & Plastic Surgery, Surgical
- HTQBroach
- GFFBur, Surgical, General & Plastic Surgery
- HTTBurr, Orthopedic
- EMLChisel, Bone, Surgical
- FZOChisel, Surgical, Manual
- HXDClamp
- HWWCountersink
- HTFCurette
- FZTCutter, Surgical
- HWRDriver, Prosthesis
- HTEElevator
- HWBExtractor
- HTPFile
- HTDForceps
- HTJGauge, Depth
- FZXGuide, Surgical, Instrument
- FZYHammer, Surgical
- HWAImpactor
- HWNInstrument, Compression
- HTZInstrument, Cutting, Orthopedic
- HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment
- HTSKnife, Orthopedic
- FQHLavage, Jet
- HXLMallet
- HWMOsteotome
- GFIOsteotome, Manual
- HWQPasser
- HXIPasser, Wire, Orthopedic
- HTCPliers, Surgical
- HXBProbe
- HSXProsthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer
- HRYProsthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer
- HRZProsthesis, Knee, Hinged (Metal-Metal)
- HWPPunch, Femoral Neck
- HXOPusher, Socket
- HTRRasp
- GACRasp, Surgical, General & Plastic Surgery
- HTOReamer
- GADRetractor
- FDGRetractor, Fiberoptic
- FNSRing Cutter
- HTXRongeur
- HSOSaw
- HRRScissors, Orthopedic, Surgical
- HWCScrew, Fixation, Bone
- HWOSkid, Bone
- HWDStarter, Bone Screw
- HRTStripper, Surgical
- HXGTamp
- HWXTap, Bone
- FTYTape, Measuring, Rulers And Calipers
- HWTTemplate
- FSMTray, Surgical, Instrument
- HWKTrephine
- HXCWrench
Recall records
Showing 25 of 33| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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 | Due to products not having FDA Premarket authorization to be distributed within the United States. | Class II | Open, Classified | |
| 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 | Femoral implant porous size 5 right primary and femoral implant non-porous size 6 left primary have correct markings on devices, but may have incorrect packaging. | Class II | Open, Classified | |
| Z-2244-2024 | EVOLUTION MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only. | One confirmed incident has been received that EFSRN4PR, lot number MP1982170, Size 4 Evolution MP Non-Porous Femoral Right was opened during surgery and contained part number EFSRN3PL, lot number MP1982097, Size 3 Evolution MP Non-Porous Femoral Left in the packaging. | Class II | Open, Classified | |
| Z-0276-2023 | EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base | One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in the packaging. | Class II | Open, Classified | |
| Z-0275-2023 | EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base | One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in the packaging. | Class II | Open, Classified | |
| Z-1225-2022 | PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK | One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body. | Class II | Terminated | |
| 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. | MicroPort Orthopedics Inc. is voluntarily recalling any existing inventory of PROFEMUR Titanium and Cobalt Chrome modular necks with previous package insert versions to replace the PROFEMUR Hip System Package Insert with the most recent revision (150803-8). | Class II | Open, Classified | |
| Z-2942-2020 | PROFEMUR Neck Extra Long Titanium, Catalog Numbers: PHA01206, PHA01236, PHA01256. Hip prosthesis component | MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titanium modular femoral neck component after implantation. Worldwide there were 680 Long and X-Long PROFEMUR Titanium modular neck fractures among 123,840 global sales representing is a cumulative rate of modular neck device fracture of 0.55% from 2002 to 2019. Within the United States there were 349 Long and X-Long PROFEMUR Titanium modular neck fractures among 15,786 United States sales representing a cumulative rate of modular neck device fracture with a fracture rate in the United States of 2.21% from 2002 to 2019. There is an average time of 5.4 years to device fracture after implantation. | Class I | Terminated | |
| Z-2941-2020 | PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip prosthesis component. | MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titanium modular femoral neck component after implantation. Worldwide there were 680 Long and X-Long PROFEMUR Titanium modular neck fractures among 123,840 global sales representing is a cumulative rate of modular neck device fracture of 0.55% from 2002 to 2019. Within the United States there were 349 Long and X-Long PROFEMUR Titanium modular neck fractures among 15,786 United States sales representing a cumulative rate of modular neck device fracture with a fracture rate in the United States of 2.21% from 2002 to 2019. There is an average time of 5.4 years to device fracture after implantation. | Class I | Terminated | |
| 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 | The item is being recalled due to an inadequate pouch seal. This defect has the potential to lead to a loss of sterile pouch integrity, which could impact the products sterility assurance and may lead to serious adverse events such as infections, both localized and systemic. | Class II | Terminated | |
| Z-0943-2017 | 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 preparation of the femoral canal for the stem component to be implanted. This | The recall is being initiated because all broach handles in the affected lot had the same non-conformity with the connection feature. The broach handles may have machining issues that do not allow the handle to properly mate with an associated broach. | Class II | Terminated | |
| Z-2588-2016 | 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 patients. | Profemur(R) neck, Item Number PHA01222 (Short AR VV2 Ti Neck) was labeled as Item Number PHA01212 (Short AR VV1 Ti Neck). | Class II | Terminated | |
| Z-0689-2017 | Cobalt Chromium Heads Transcend: 26000017, 26000018, 26000019, 26000020, 26000021, 26000022, 26000023, 26000024, 26000025, 26000026, 26000027, 26000028 Conserve: 38013800, 38013804, 38013835, 38014000, 38014004, 38014035, 38014200, 38014204, 38014235, 38014400, 38014404, 38014435, 38014600, 38014604, 38014635, 38014800, 38014804, 38014835, 38015000, 38015004, 38015035, 38015200, 38015204, 38015235, 38015400, 38015404, 38015435, 38015600, 38015604, 38015635, 38AC3600, 38AC3800, 38AC4000, 38AC4200, 38AC4400, 38AC4600, 38AC4800, 38AC5000, 38AC5200, 38AC5400, 38AC5600, 38AM3600, 38AM3604, 38AM3635, 38AM3800, 38AM3804, 38AM3835, 38AM4000, 38AM4004, 38AM4035, 38AM4200, 38AM4204, 38AM4235, 38AM4400, 38AM4404, 38AM4435, 38AM4600, 38AM4604, 38AM4635, 38AM4800, 38AM4804, 38AM4835, 38AM5000, 38AM5004, 38AM5035, 38AM5200, 38AM5204, 38AM5235, 38AM5400, 38AM5404, 38AM5435, 38AM5600, 38AM5604, 38AM5635, PL38HM4400, PL38HM4404, PL38HM4435, PL38HM4600, PL38HM4604, PL38HM4635, PL38HM4800, PL38HM4804, PL38HM4835, PL38HM5000, PL38HM5004, PL38HM5035, PL38HM5200, PL38HM5204, PL38HM5235 | Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems. | Class III | Terminated | |
| Z-0688-2017 | 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 38BF4854, REF 38BF5056, REF 38BF5258, REF 38BF5258SP, REF 38BF5460, REF 38BF5460SP, REF 38BF5662, REF 38BF5662SP, REF 38BF5864, REF 38BF5864SP, REF 38BF6066, REF 38BF6066SP, REF 38QH3644, REF 38QH3846, REF 38QH4048, REF 38QH4250, REF 38QH4452, REF 38QH4654, REF 38QH4856, REF 38QH5058, REF 38QH5260, REF 38QH5462, REF 38QH5664, REF 38QH5666, REF 38SC3650, REF 38SC3852, REF 38SC4054, REF 38SC4256, REF 38SC4458, REF 38SC4660, REF 38SC4862, REF 38SC5064, REF 38SC5266, REF 38SC5468, REF 38SC5670, REF 38SC5672 For use with the conserve metal head | Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems. | Class III | Terminated | |
| Z-0687-2017 | 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, REF 38023848, REF 38024046, REF 38024050, REF 38024248, REF 38024252, REF 38024450, REF 38024454, REF 38024652, REF 38024656, REF 38024854, REF 38024858, REF 38025056, REF 38025060, REF 38025258, REF 38025262, REF 38025460, REF 38025464, REF 38025662, REF 38025664, REF 38025666, REF 38025668, REF 38123844, REF 38124046, REF 38124248, REF 38124450, REF 38125056, REF 38125662, REF 38HA3642, REF 38HA3844, REF 38HA4046, REF 38HA4248, REF 38HA4450, REF 38HA4652, REF 38HA4854, REF 38HA5056, REF 38HA5258, REF 38HA5460, REF 38HA5662, REF 38HA5664, REF 38HA5864, REF 38HA6066, REF 38SP3642, REF 38SP3844, REF 38SP4046, REF 38SP4248, REF 38SP4450, REF 38SP4652, REF 38SP4854, REF 38SP5056, REF 38SP5258, REF 38SP5460, REF 38SP5662, REF 38SP5664 For use with the conserve metal head | Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems. | Class III | Terminated | |
| Z-0686-2017 | 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 | Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems. | Class III | Terminated | |
| Z-0685-2017 | 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 | Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems. | Class III | Terminated | |
| Z-0684-2017 | 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 | Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems. | Class III | Terminated | |
| Z-0683-2017 | 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 | Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems. | Class III | Terminated | |
| Z-2703-2016 | 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, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques. | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. | Class I | Terminated | |
| Z-2702-2016 | 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, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques. | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. | Class I | Terminated | |
| Z-2701-2016 | 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, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques. | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. | Class I | Terminated | |
| Z-2700-2016 | 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, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques. | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. | Class I | Terminated | |
| Z-2699-2016 | 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, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques. | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. | Class I | Terminated | |
| Z-2698-2016 | 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, STERILE R, Rx ONLY,MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques. | ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening. | Class I | Terminated |
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