510(k) K091956 ยท OIY Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive
HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS, MODEL 391/392-09_19-702_712
| Applicant | Encore Medical L.P., Austin TX, US |
| Decision | Substantially Equivalent, Sep 28, 2010 |
| Received | Jul 1, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091956
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 31, 2017 | Encore Medical, Lp 3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01,
The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused Terminated |
JWH | None listed |
| May 31, 2017 | Encore Medical, Lp 3DKNEE(TM) SYSTEM e+, Tibial Insert, RIGHT Sz 8 / 11mm, REF 391-11-708, QTY 01
The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused w Terminated |
JWH | None listed |
| May 2, 2013 | Encore Medical, Lp 3DKnee e+ Tibial Insert. The insert is used along with the other components that comprise the 3DKnee System. Terminated |
OIY | None listed |
| Aug 30, 2012 | Encore Medical, Lp 3DKnee e+ Tibial Insert - HXLPE-VE, Sterile, Material: Highly cross linked vitamin E PE, Sz 2/9mm.
The insert is intended to more closely match the kinematics of the knee, allowing some rotation alon Terminated |
OIY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.