510(k) K170613 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Genius Total Knee System
| Applicant | Signature Orthopaedics Pty, Ltd., Lane Cove West, AU |
| Decision | Substantially Equivalent, Jul 17, 2017 |
| Received | Mar 1, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170613
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 10, 2018 | Signature Orthopedics Pty Limited Genius Knee Cemented Tibial Component
Product Usage:
Knee replacement component Terminated |
JWH | None listed |
| Dec 10, 2018 | Signature Orthopedics Pty Limited Genius Knee Cemented CR Femoral Component
Product Usage:
Knee replacement component Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.