510(k) K051023 ยท HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
TOPEZ TOTAL ANKLE REPLACEMENT
| Applicant | Topez Orthopedics, Inc., Boulder CO, US |
| Decision | Substantially Equivalent, Nov 15, 2005 |
| Received | Apr 22, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051023
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 27, 2022 | Wright Medical Technology, Inc. Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3 Terminated |
HSN | None listed |
| Oct 27, 2022 | Wright Medical Technology, Inc. Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4 Terminated |
HSN | None listed |
| Apr 9, 2020 | Wright Medical Technology Inc WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage: is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion a Terminated |
HSN | None listed |
| Nov 8, 2016 | Wright Medical Technology, Inc. INBONE STEM, TIBIAL, TOP, Part Number 200011901 Terminated |
HSN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.