510(k) K160025 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System
| Applicant | Conformis, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, Mar 7, 2016 |
| Received | Jan 6, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160025
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 18, 2016 | ConforMIS, Inc. ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile
Catalog Number: TCR-111-1111.
Intended for use as a total knee replacement in patients with knee joint pain and disability wh Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.