510(k) K002335 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
NATURAL-KNEE II SYSTEM-DURASUL TIBIAL INSERT AND DURASUL ALL-POLY PATELLA
| Applicant | Sulzer Orthopedics, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Oct 25, 2000 |
| Received | Aug 1, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002335
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 25, 2012 | Zimmer Inc. Natural-Knee II Durasul All-Poly Patella, Size 0, 7mm
The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed component Terminated |
JWH | None listed |
| Jan 25, 2012 | Zimmer Inc. Natural-Knee II Durasul All-Poly Patella, Size 1, 7mm
The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed component Terminated |
JWH | None listed |
| Jan 25, 2012 | Zimmer Inc. Natural-Knee II Durasul All-Poly Patella, Size 2, 7mm
The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed component Terminated |
JWH | None listed |
| Jan 25, 2012 | Zimmer Inc. Natural-Knee II Durasul All-Poly Patella, Size 3, 7mm
The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed component Terminated |
JWH | None listed |
| Jan 25, 2012 | Zimmer Inc. Natural-Knee II Durasul All-Poly Patella, Size 0, 10mm
The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed componen Terminated |
JWH | None listed |
| Jan 25, 2012 | Zimmer Inc. Natural-Knee II Durasul All-Poly Patella, Size 1, 10mm
The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed componen Terminated |
JWH | None listed |
| Jan 25, 2012 | Zimmer Inc. Natural-Knee II Durasul All-Poly Patella, Size 2, 10mm
The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed componen Terminated |
JWH | None listed |
| Jan 25, 2012 | Zimmer Inc. Natural-Knee II Durasul All-Poly Patella, Size 3, 10mm
The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed componen Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.