510(k) K121297 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULAR
| Applicant | Signature Orthopaedics Pty, Ltd., Chatswood, AT |
| Decision | Substantially Equivalent, Dec 28, 2012 |
| Received | Apr 30, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121297
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 20, 2021 | Signature Orthopedics Pty Limited Logical cup liner - Product Usage: intended to replace a hip joint where bone stock is sufficient to support the implant. Terminated |
MEH | None listed |
| Feb 2, 2018 | Signature Orthopedics Pty Limited Signature Ceramic Femoral Head. Model Number: 111-152-621.
The Signature ceramic femoral heads are manufactured by Ceramtec from 72-75% Al2O3+24-26% Z3O3 (Biolox Delta).
The heads connect via a 12/14 Terminated |
MEH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.