510(k) K041100 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
NEXGEN POROUS, HA/TCP, UNCEMENTED FEMORAL AND TIBIAL BASEPLATE COMPONENTS
| Applicant | Zimmer, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Oct 29, 2004 |
| Received | Apr 27, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K041100
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 29, 2017 | Zimmer Biomet, Inc. CR-FLX POR HATCP FEM C-L MINUS
CR-FLX POR HATCP FEM C-R MINUS
CR-FLX POR HATCP FEM D-L MINUS
CR-FLX POR HATCP FEM D-R MINUS
CR-FLX POR HATCP FEM E-L MINUS
CR-FLX POR HATCP FEM E-R MINUS
CR-FLX POR HAT Terminated |
MBH | None listed |
| Nov 29, 2017 | Zimmer Biomet, Inc. CR-FLEX POR HATCP FEM C-L
CR-FLEX POR HATCP FEM C-R
CR-FLEX POR HATCP FEM D-L
CR-FLEX POR HATCP FEM D-R
CR-FLEX POR HATCP FEM E-L
CR-FLEX POR HATCP FEM E-R
CR-FLEX POR HATCP FEM F-L
CR-FLEX POR HATCP Terminated |
MBH | None listed |
| Nov 29, 2017 | Zimmer Biomet, Inc. CR-FLEX POR FEM F-L
CR-FLEX POR FEM F-R MINUS
CR-FLEX POR FEM G-L
This device is indicated for patients with severe knee pain and disability Terminated |
MBH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.