510(k) K142161 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM, ITOTAL POSTERIOR STABILIZED (PS) KNEE REPLACEMENT SYSTEM
| Applicant | Conformis, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, Nov 14, 2014 |
| Received | Aug 6, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K142161
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 28, 2016 | ConforMIS, Inc. Conformis iTotal Cruciate Retaining (CR) Knee Replacement System
Model: TCR-111-1111 Terminated |
JWH | None listed |
| 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 CR Knee Replacement System-
ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - LEFT
ITOTAL CR - IPOLY - IMPLANT KIT UNCAPTURED - RIGHT
Catalog Number: TCR1111111 Terminated |
JWH | None listed |
| Oct 21, 2015 | ConforMIS, Inc. ConForMIS iTotal CR (Cruciate Retaining) Knee Replacement System-iTOTAL CR, Left Knee
Catalog Number: M57250600010 (US)
M5725INT0600010 (OUS) Terminated |
JWH | None listed |
| Oct 21, 2015 | ConforMIS, Inc. ConFormis iTotal CR Knee Replacement System-
iTOTAL CR, Right Knee
Catalog Number: M57250600020 (US)
M5725INT0600020 (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.