510(k) K000666 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
TC-PLUS SOLUTION KNEE
| Applicant | Plus Orthopedics, San Diego CA, US |
| Decision | Substantially Equivalent, Oct 13, 2000 |
| Received | Feb 28, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K000666
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2005 | Plus Orthopedics USA TC-PLUS Solution Femoral Component, model 21028, Femoral component, right, size 8. Terminated |
JWH | None listed |
| Oct 7, 2005 | Plus Orthopedics USA TC-PLUS Tibial Insert Ultra-Congruent Size 10 ; 9 mm, Model 25456 Terminated |
JWH | None listed |
| Oct 7, 2005 | Plus Orthopedics USA TC-PLUS Tibial Insert 2; 15mm, Model 25309 Terminated |
JWH | None listed |
| Oct 7, 2005 | Plus Orthopedics USA TC-PLUS Tibial Insert UC 4; 11mm, Model 25427 Terminated |
JWH | None listed |
| Oct 7, 2005 | Plus Orthopedics USA TC-PLUS Tibial Insert UC 4; 13mm, Model 25428 Terminated |
JWH | None listed |
| Oct 7, 2005 | Plus Orthopedics USA TC-PLUS Tibial Insert UC 6; 9 mm, Model 25436 Terminated |
JWH | None listed |
| Oct 7, 2005 | Plus Orthopedics USA TC-PLUS Tibial Insert UC 6; 13mm, Model 25438 Terminated |
JWH | None listed |
| Oct 7, 2005 | Plus Orthopedics USA TC-PLUS Tibial Insert UC 10; 11mm, Model 25457 Terminated |
JWH | None listed |
| Oct 15, 2003 | Plus Endoprothetik AG TC-PLUS Solution Tibial Component-- Symmetric Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.