510(k) K140881 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
DEPUY ATTUNE KNEE SYSTEM - CEMENTLESS CR AND PS FEMORAL COMPONENETS
| Applicant | Depuy(Ireland), Co. Cork, IE |
| Decision | Substantially Equivalent, Feb 13, 2015 |
| Received | Apr 7, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140881
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2015 | DePuy Orthopaedics, Inc. ATTUNE FB PS ARTICULATION SURFACE SIZES 3-8
INTENDED USE:
The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. Terminated |
MBH | None listed |
| Jul 20, 2015 | DePuy Orthopaedics, Inc. ATTUNE FB CR ARTICULATION SURFACE SIZE 3-8
INTENDED USE:
The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. Terminated |
MBH | None listed |
| Jul 20, 2015 | DePuy Orthopaedics, Inc. ATTUNE RP PS ARTICULATION SURFACE SIZE 3-8
INTENDED USE:
The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. Terminated |
MBH | None listed |
| Jul 20, 2015 | DePuy Orthopaedics, Inc. ATTUNE CONV RP CR ARTICULATION SURFACE SZ1, 2, 9, and 10
INTENDED USE:
The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total kne Terminated |
MBH | None listed |
| Jul 20, 2015 | DePuy Orthopaedics, Inc. ATTUNE RP CR ARTICULATION SURFACE SIZE 3-8
INTENDED USE:
The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Terminated |
MBH | None listed |
| Jul 20, 2015 | DePuy Orthopaedics, Inc. ATTUNE CONV FB PS ARTICULATION SURFACE SZ1-10
INTENDED USE:
The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacemen Terminated |
MBH | None listed |
| Jul 20, 2015 | DePuy Orthopaedics, Inc. ATTUNE CONV RP PS ARTICULATION SURFACE SZ1-9
INTENDED USE:
The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement Terminated |
MBH | None listed |
| Jul 20, 2015 | DePuy Orthopaedics, Inc. ATTUNE CONV RP PS TB TRL SZ10
INTENDED USE:
The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal is Terminated |
MBH | None listed |
| Jul 20, 2015 | DePuy Orthopaedics, Inc. ATTUNE CONV FB CR ARTICULATION SURFACE SZ1
INTENDED USE:
The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. Terminated |
MBH | None listed |
| Jul 20, 2015 | DePuy Orthopaedics, Inc. ATTUNE CONV FB CR TB TRL SZ3 - 10
INTENDED USE:
The Tibial Articulation Surface Trial snaps together with the Shim component to function as the Insert Trial during a total knee replacement. A Balseal Terminated |
MBH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.