510(k) K033883 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED FEMORAL COMPONENTS, HI-FLEX POSTERIOR-STABI
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent, Feb 13, 2004 |
| Received | Dec 15, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K033883
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 18, 2024 | Exactech, Inc. Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009 Open, Classified |
JWH | None listed |
| Oct 4, 2021 | Exactech, Inc. OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following:
a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX;
b. OPTETRAK Logic PSC Tibial Inserts, Product Line 02-012- Open, Classified |
JWH | None listed |
| Jan 5, 2015 | Exactech, Inc. Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03.
Usage:Femoral implants Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.