510(k) K032151 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
DEPUY SIGMA TIBIAL INSERTS AND CO-CR TIBIAL TRAYS
| Applicant | Depuy, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Sep 26, 2003 |
| Received | Jul 14, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K032151
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 27, 2013 | DePuy Orthopaedics, Inc. SIGMA LCS HIGH PERFORMANCE"
MBT KEEL PUNCH CEMENTED
SIZE 1-1.5
HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray Terminated |
JWH | None listed |
| Nov 27, 2013 | DePuy Orthopaedics, Inc. SIGMA LCS HIGH PERFORMANCE"
MBT KEEL PUNCH CEMENTED
Size 2-3
HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray Terminated |
JWH | None listed |
| Nov 27, 2013 | DePuy Orthopaedics, Inc. SIGMA LCS HIGH PERFORMANCE"
MBT KEEL PUNCH CEMENTED
Size 4-7
HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray us Terminated |
JWH | None listed |
| Nov 27, 2013 | DePuy Orthopaedics, Inc. SIGMA LCS HIGH PERFORMANCE"
MBT KEEL PUNCH NONCEMENTED
Size 1-1.5
HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tr Terminated |
JWH | None listed |
| Nov 27, 2013 | DePuy Orthopaedics, Inc. SIGMA LCS HIGH PERFORMANCE"
MBT KEEL PUNCH NONCEMENTED
Size 2-3
HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tra Terminated |
JWH | None listed |
| Nov 27, 2013 | DePuy Orthopaedics, Inc. SIGMA LCS HIGH PERFORMANCE"
MBT KEEL PUNCH NONCEMENTED
Size 4-7
HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray Terminated |
JWH | None listed |
| Nov 27, 2013 | DePuy Orthopaedics, Inc. SIGMA LCS HIGH PERFORMANCE"
MBT PUNCH CEMENTED
Size 1-1.5
HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used Terminated |
JWH | None listed |
| Nov 27, 2013 | DePuy Orthopaedics, Inc. SIGMA LCS HIGH PERFORMANCE"
MBT PUNCH CEMENTED
Size 2-3
HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used du Terminated |
JWH | None listed |
| Nov 27, 2013 | DePuy Orthopaedics, Inc. SIGMA LCS HIGH PERFORMANCE"
MBT PUNCH CEMENTED
Size 4-7
HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used du Terminated |
JWH | None listed |
| Nov 27, 2013 | DePuy Orthopaedics, Inc. SIGMA LCS HIGH PERFORMANCE"
MBT PUNCH NONCEMENTED
Size 1-1.5
HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray us Terminated |
LXH | None listed |
| Nov 27, 2013 | DePuy Orthopaedics, Inc. SIGMA LCS HIGH PERFORMANCE"
MBT PUNCH NONCEMENTED
Size 2-3
HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used Terminated |
LXH | None listed |
| Nov 27, 2013 | DePuy Orthopaedics, Inc. SIGMA LCS HIGH PERFORMANCE"
MBT PUNCH NONCEMENTED
Size 4-7
HP M.B.T. Keel Punch Knee Instrument is used to prepare the proximal tibial canal geometry to accept the final or definitive tibial tray used Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.