510(k) K142404 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
iTotal Posterior Stabilized (PS) Knee Replacement System
| Applicant | Conformis, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, Dec 11, 2014 |
| Received | Aug 27, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K142404
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 21, 2015 | ConforMIS, Inc. ConForMIS iUni Unicondylar Knee Replacement System-
iUNI G2, Right Medial
Catalog Number:M57220600220 (US)
M5722INT0600220 (OUS) Terminated |
JWH | None listed |
| Oct 21, 2015 | ConforMIS, Inc. ConFormis iTotal Posterior Stabilized Knee Replacement System-
ITOTAL PS-IPOLY- IMPLANT KIT-LEFT and
ITOTAL PS-IPOLY-IMPLANT KIT-RIGHT
Catalog Number:TPS1111111 Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.