510(k) K113060 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
UNITY TOATAL KNEE SYSTEM
| Applicant | Corin USA, Tampa FL, US |
| Decision | Substantially Equivalent, Sep 10, 2012 |
| Received | Oct 14, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113060
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2026 | CORIN MEDICAL, LTD. Unity Knee ASC Modular Handle included in the Corin UNITY ASC INSTRUMENT SYSTEM. Part Number: 1232040. Open, Classified |
JWH | None listed |
| Nov 2, 2023 | Corin Ltd Unity CR Femur Right, Size 6, Model Number 112.001.32
Primary and revision total knee arthroplasty Open, Classified |
JWH | None listed |
| Nov 2, 2023 | Corin Ltd Unity Total Knee System, Model Number 112.001.34.
Primary and revision total knee arthroplasty Open, Classified |
JWH | None listed |
| Nov 21, 2022 | Corin Ltd Unity Total Knee System.
Used for knee prosthesis in total knee replacement Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.