510(k) K171991 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
EMPOWR Porous Knee System
| Applicant | Encore Medical L.P., Austin TX, US |
| Decision | Substantially Equivalent, Oct 4, 2017 |
| Received | Jul 3, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171991
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 7, 2023 | Encore Medical, LP DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108
DJO surgical EMPOWR KNEE", PRESS FIT BP MINUS, 8L REF 353-03-108
For the treatment of Open, Classified |
MBH | None listed |
| Nov 7, 2023 | Encore Medical, LP DJO EMPOWR Knee Punch Handle, REF: 801-05-040 Open, Classified |
MBH | None listed |
| Oct 7, 2020 | Encore Medical, LP DJO EMPOWR Tibial Knee Punch Handle Part No. 801-05-040 and 801-05-018 contained in Instrument Tray for EMPOWR Porous Knee - Product Usage: The Tibial Punch Handle is used in conjunction with one of Open, Classified |
MBH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.