Arlington, TN, US · 15 510(k) clearances · 9 recalls (2 Class I)
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class II | Orthopedic | 3 | 2025-05-15 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | Class II | Orthopedic | 2 | 2025-02-18 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class II | Orthopedic | 2 | 2024-04-18 |
| KRO | — | — | — | 2 | 2024-04-01 |
| MBH | Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | Class II | Orthopedic | 2 | 2024-01-18 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Class II | Orthopedic | 2 | 2022-01-05 |
| MBL | — | — | — | 1 | 2021-08-24 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Class II | Orthopedic | 1 | 2021-08-20 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-12-19 | Class II | Ongoing | Z-1133-2026 | Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Vers… | — | Due to products not having FDA Premarket authorization to be distributed within the United States. |
| 2024-10-29 | Class II | Ongoing | Z-0699-2025 | EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR… | — | 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 packagin… |
| 2024-05-03 | Class II | Ongoing | 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 contain… |
| 2022-10-28 | Class II | Ongoing | 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 191671… |
| 2022-10-28 | Class II | Ongoing | 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 191671… |
| 2022-05-04 | Class II | Terminated | 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. |
| 2020-07-31 | Class II | Ongoing | Z-2948-2020 | PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descriptions: Item Number Description Description 2… | — | MicroPort Orthopedics Inc. is voluntarily recalling any existing inventory of PROFEMUR¿ Titanium and Cobalt Chrome modular necks with previous package insert ve… |
| 2020-07-31 | Class I | Terminated | 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 implantatio… |
| 2020-07-31 | Class I | Terminated | Z-2941-2020 | PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hi… | — | MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titanium modular femoral neck component after implantatio… |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-05-15 | K250444 | NEXUS® Hip Stem | LZO | Class II | Orthopedic |
| 2025-02-18 | K243574 | Evolution® Total Knee Systems - Kinematic Alignment Instrumentation and Technique | JWH | Class II | Orthopedic |
| 2024-04-18 | K240046 | Ethylene Oxide Sterilization Supplier Change for MPO Hips | LPH | Class II | Orthopedic |
| 2024-04-12 | K240452 | Ceramic Femoral Head | LZO | Class II | Orthopedic |
| 2024-04-01 | 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 | — | — |
| 2024-01-18 | K233507 | EVOLUTION® Tibial Cones | MBH | Class II | Orthopedic |
| 2023-10-31 | K231947 | EVOLUTION® Cement Keel | JWH | Class II | Orthopedic |
| 2023-09-27 | K230563 | EVOLUTION® Hinge Knee System | KRO | — | — |
| 2022-01-05 | K213817 | MPO Knee Instruments; MPO PROPHECY Knee Instruments | MBH | Class II | Orthopedic |
| 2022-01-05 | K213816 | MPO Hip Instruments | JDI | Class II | Orthopedic |
| 2021-10-01 | K200011 | E-CLASS® DUAL MOBILITY INSERTS and DYNASTY® DUAL MOBILITY LINERS | LPH | Class II | Orthopedic |
| 2021-08-24 | K201157 | Prime BIOFOAM® Multi-Hole Shells | MBL | — | — |
| 2021-08-20 | K202705 | Prime and DYNASTY® Additive Manufacturing Shells | OQG | Class II | Orthopedic |
| 2020-12-10 | K201519 | PROFEMUR® GLADIATOR® Cemented Classic Stem | JDI | Class II | Orthopedic |
| 2020-04-25 | K200007 | PROFEMUR GLADIATOR Thin HA Classic Hip Stem with Collar | LZO | Class II | Orthopedic |