510(k) K160700 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
ATTUNE Revision Knee System
| Applicant | Depuy(Ireland), Cork, IE |
| Decision | Substantially Equivalent, Jun 10, 2016 |
| Received | Mar 14, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160700
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2022 | DePuy Orthopaedics, Inc. ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries
Product Number: 154909003 Terminated |
JWH | None listed |
| Jan 5, 2022 | DePuy Orthopaedics, Inc. ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surgeries
Product Number: 154706001 Terminated |
JWH | None listed |
| Jul 1, 2021 | DePuy Orthopaedics, Inc. ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty
Part Number: 1512-16-080 Terminated |
JWH | None listed |
| Apr 30, 2018 | DePuy Orthopaedics, Inc. ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee Terminated |
JWH | None listed |
| Apr 30, 2018 | DePuy Orthopaedics, Inc. ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.