510(k) K020114 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
3D KNEE
| Applicant | Encore Orthopedics, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Jul 12, 2002 |
| Received | Jan 11, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020114
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 22, 2010 | Encore Medical, Lp 3DKnee Baseplates, Size 8, Left, Part # 333-01-108, Lot# A1000003. Terminated |
JWH | None listed |
| Apr 26, 2010 | Encore Medical, Lp 3DKNEE SYSTEM, 3D Knee Tibial Insert-DCM, Sterile, Right, size 4 x 11mm. Encore Medical, LP. Austin, TX 78758-5445.
Intended to aid the surgion in relieving the patient of knee pain and restoring k Terminated |
JWH | None listed |
| Aug 20, 2008 | Encore Medical, Lp 3DKNEE Tibial Insert Trial, Size 2, 13mm Right; Part #801-01-640; manufactured by Encore Medical, L.P., Austin, TX 78758.
Used in surgery to determine the correct size of 3DKnee component to implant Terminated |
JWH | None listed |
| Dec 29, 2005 | Encore Medical, Lp Size 8 right 3DKnee Non-porous Baseplates (Catalog #333-02-108) joint knee replacement. Terminated |
JWH | None listed |
| Jul 20, 2004 | Encore Medical, LP 3DKnee System, Stemmed Tibia-Nonporous-3D, Size 6, Right, sterile. Manufactured by Encore Orthopeadics, 9800 Metric Blvd., Austin, Texas 78758 Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.