510(k) K161668 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
ConforMIS iTotal(R) Posterior Stabilized (PS) Knee Replacement System (iTotal PS)
| Applicant | Conformis, Inc., Bedford MA, US |
| Decision | Substantially Equivalent, Jul 15, 2016 |
| Received | Jun 16, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161668
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 3, 2020 | Conformis, Inc. iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT) Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacemen Terminated |
JWH | None listed |
| Jan 4, 2019 | Conformis, Inc. iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102 Terminated |
JWH | None listed |
| Jul 24, 2017 | ConforMIS, Inc. Total Knee Replacement , Catalog/Model # TPS-111-1111, UDI: +M572TPS1111111021/$$+31712310398482- and +M572TPS1111111021/$$+31712310399917/
Intended for use as a total knee replacement in patients wi Terminated |
JWH | None listed |
| Jan 10, 2017 | ConforMIS, Inc. ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT
Catalog Number:TPS-111-1111
The iTotal PS Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disab Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.