510(k) K180906 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Conformis iTotal Cruciate Retaining (CR) Knee Replacement System
| Applicant | Conformis, Inc., Billerica MA, US |
| Decision | Substantially Equivalent, May 16, 2018 |
| Received | Apr 6, 2018 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K180906
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2020 | Conformis, Inc. Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant
Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) Terminated |
JWH | None listed |
| Feb 3, 2020 | Conformis, Inc. iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) - Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee repla Terminated |
JWH | None listed |
| Oct 25, 2019 | Conformis, Inc. iTotal CR Knee Replacement System
Model Number: TCR-111-1111-010102 - Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint p Terminated |
JWH | None listed |
| Dec 3, 2018 | Conformis, Inc. iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.)
M5725INT0600010 (Model No.)
Product Usage:
The iTotal CR Knee Replacement System is intended for Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.