510(k) K140735 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
EVOLUTION MP CS/CR POROUS FEMUR/EVOLUTION ADAPTIVE CS AND PS INSERTS
| Applicant | Microport Orthopedics, Inc., Arlington TN, US |
| Decision | Substantially Equivalent, Aug 29, 2014 |
| Received | Mar 24, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140735
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.