510(k) K943462 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
DARWIN KNEE SYSTEM
| Applicant | Johnson & Johnson Professionals, Inc., Raynham MA, US |
| Decision | Substantially Equivalent for Some Indications, Dec 21, 1994 |
| Received | Jul 18, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K943462
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 24, 2014 | DePuy Orthopaedics, Inc. PFC SIGMA Cruciate Retaining (CR); Cemented Femoral devices; (Size 5/RT)
Used during primary total knee arthroplasty to improve patient mobility. Terminated |
JWH | None listed |
| Aug 21, 2009 | Depuy Orthopaedics, Inc. DePuy P.F.C. Sigma Knee System, Non-Porous Cruciate Retaining Femoral Component, 73 mm M/L 69 mm A/P, 5 left, sterile, DePuy Orthopaedics, Inc., Warsaw, IN; REF 96-0005.
The device is used for total Terminated |
JWH | None listed |
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 2.5, 8 mm, 67mm M/L, 45 mm A/P, UHMWPE, 2.5, sterile; Product Code/REF 96-0630. Terminated |
NJL | None listed |
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 3, 8 mm, 71mm M/L, 47 mm A/P, UHMWPE, sterile; Product Code/ REF 96-0640. Terminated |
NJL | None listed |
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 3, 10mm, 71mm M/L, 47mm A/P, UHMWPE, sterile; Product Code/REF 96-0641. Terminated |
NJL | None listed |
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 4, 8mm, 76mm M/L, 51mm A/P, UHMWPE, sterile; Product Code/REF 96-0650. Terminated |
NJL | None listed |
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 4, 10mm, 76mm M/L, 51mm A/P, UHMWPE, sterile; Product Code/REF 96-0651. Terminated |
NJL | None listed |
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy P.F.C. E Knee System All Polyethylene Curved Tibial Component, 5, 15mm, 83mm M/L, 55mm A/P, UHMWPE, sterile; Product Code/REF 96-0663. Terminated |
NJL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.