510(k) K093552 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
EVOLUTION MP TOTAL KNEE SYSTEM
| Applicant | Wrightmedicaltechnologyinc, Arlington TN, US |
| Decision | Substantially Equivalent, Mar 4, 2010 |
| Received | Nov 17, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093552
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| Nov 22, 2022 | MicroPort Orthopedics Inc. EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base Terminated |
HRY | None listed |
| Nov 22, 2022 | MicroPort Orthopedics Inc. EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base Terminated |
HRY | None listed |
| 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 | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.