510(k) K933610 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
EXACTECH CEMENTED TOTAL KNEE SYSTEM, TIBIAL COMPONENTS
| Applicant | Exactech, Inc., Gainesville FL, US |
| Decision | Substantially Equivalent for Some Indications, Jan 17, 1995 |
| Received | Jul 27, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K933610
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 18, 2024 | Exactech, Inc. OPTETRAK Three Peg Patella, Item Numbers:
a) 200-02-26, 26MM;
b) 200-02-29, 29MM;
c) 200-02-32, 32MM;
d) 200-02-35, 35MM;
e) 200-02-38, 38MM;
f) 200-02-41, 41MM; Open, Classified |
JWH | None listed |
| Jun 18, 2024 | Exactech, Inc. OPTETRAK One Peg Patella,, Item Numbers:
a) 200-03-26, 26MM;
b) 200-03-29, 29MM;
c) 200-03-32, 32MM;
d) 200-03-35, 35MM;
e) 200-03-38, 38MM;
f) 200-03-41, 41MM Open, Classified |
JWH | None listed |
| Jun 18, 2024 | Exactech, Inc. OPTETRAK Inset Patella, Item Numbers:
a) 200-05-23, 23MM;
b) 200-05-26, 26MM;
c) 200-05-29, 29MM Open, Classified |
JWH | None listed |
| Jun 18, 2024 | Exactech, Inc. OPTETRAK, Advanced Patella, 3 Peg Implant, Item Numbers:
a) 200-07-26, 26MM;
b) 200-07-29, 29MM;
c) 200-07-32, 32MM;
d) 200-07-35, 35MM;
e) 200-07-38, 38MM Open, Classified |
JWH | None listed |
| Jan 18, 2024 | Exactech, Inc. Exactech Optetrak Knee System, Catalog Numbers:
a) 200-02-26,
b) 200-02-29,
c) 200-02-32,
d) 200-02-35,
e) 200-02-38,
f) 200-02-41,
g) 200-03-32,
h) 200-07-29,
i) 200-07-32,
j) 200-07-35,
Open, Classified |
JWH | None listed |
| Jul 24, 2012 | Exactech, Inc. Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti Alloy*** SIZE 1F/1T, 2F/1T***FOR CEMENTED USE ONLY***Exactech, Gainesville, FL 32653-1630.***REF 204-04-21***".
The O Terminated |
JWH | None listed |
| Dec 23, 2004 | Exactech, Inc. Cemented Trapezoid Tibial Tray Sz. 4F/4T, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis. Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.