510(k) K160342 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
EMPOWR PS Knee System
| Applicant | Encore Medical L.P., Austin TX, US |
| Decision | Substantially Equivalent, May 19, 2016 |
| Received | Feb 8, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160342
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 15, 2017 | Encore Medical, Lp EMPOWR PS KNEE(TM) e+, REF 343-13-708, SIZE 8, 13mm, QTY 01, SKY BLUE, STERILE
Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused Terminated |
JWH | None listed |
| Sep 15, 2017 | Encore Medical, Lp EMPOWR PS KNEE(TM) e+, REF 343-19-707, SIZE 7, 19mm, QTY 01, GREY, STERILE
Product Usage The EMPOWR PS Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with Terminated |
JWH | None listed |
| Feb 3, 2017 | Encore Medical, Lp Empowr PS Knee Tibial Insert; Model 343-14-709
The EMPOWR PS tibial insert are made from Highly Cross-Linked Vitamin E (HXL VE) UHMWPE. The tibial insert implants are intended to mate with tibial base Terminated |
JWH | None listed |
| Sep 19, 2016 | Encore Medical, Lp Empowr PS Knee System Box Cut Guide; Used to make the housing resection for the post of the posterior stabilized implant. Terminated |
JWH | None listed |
| Sep 19, 2016 | Encore Medical, Lp Empowr PS Knee System Box Cut Guide
The EMPOWER PS Box Cut Guide is used to make the housing resection for the post of the posterior stabilized implant Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.