510(k) K210809 · JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
iTotal® Identity Cruciate Retaining (CR) Knee Replacement System (KRS)
| Applicant | Conformis, Inc., Billerica MA, US |
| Decision | Substantially Equivalent, May 12, 2021 |
| Received | Mar 17, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K210809
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 22, 2022 | Conformis, Inc. iTotal Identity Posterior Stabilised (PS) Knee Replacement System
Model Number: TPS-301-1113-020101 Completed |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.