510(k) K950010 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
DARWIN KNEE SYSTEM (CRUCIATE SUBSTITUTING) POROUS COATED AND NON-POROUS COATED
| Applicant | Johnson & Johnson Professionals, Inc., Raritan NJ, US |
| Decision | Substantially Equivalent for Some Indications, May 15, 1995 |
| Received | Jan 3, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950010
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 8.0 mm, 2.5, sterile; Product Code/REF 96-0430. Terminated |
NJL | None listed |
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 10.0 mm, 2.5, UHMWPE, sterile; Product Code/REF 96-0431. Terminated |
NJL | None listed |
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 12.5 mm, 2.5, UHMWPE, sterile; Product Code/REF 96-0432. Terminated |
NJL | None listed |
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 67 mm M/L, 45 mm A/P, 15.0 mm, 2.5, UHMWPE, sterile; Product Code/REF 96-0433. Terminated |
NJL | None listed |
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 71 mm M/L, 47 mm A/P, 8.0 mm, 3, UHMWPE, sterile; Product Code/REF 96-0440. Terminated |
NJL | None listed |
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 71 mm M/L, 47 mm A/P, 10.0 mm, 3, UHMWPE, sterile; Product Code/REF 96-0441. Terminated |
NJL | None listed |
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 71 mm M/L, 47 mm A/P, 12.5 mm, 3, UHMWPE, sterile; Product Code/REF 96-0442. Terminated |
NJL | None listed |
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 76 mm M/L, 51 mm A/P, 10.0 mm, 4, UHMWPE, sterile; Product Code/REF 96-0451. Terminated |
NJL | None listed |
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 76 mm M/L, 51 mm A/P, 12.5 mm, 4, UHMWPE, sterile; Product Code/REF 96-0452. Terminated |
NJL | None listed |
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy P.F.C. E Knee SystemStabilized Tibial Insert (STAB), 76 mm M/L, 51 mm A/P, 15.0 mm, 4, UHMWPE, sterile; Product Code/REF 96-0453. Terminated |
NJL | None listed |
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy P.F.C. E Knee System Stabilized Tibial Insert (STAB), 89 mm M/L, 59 mm A/P, 10.0 mm, 6, UHMWPE, sterile; Product Code/REF 96-0471. Terminated |
NJL | None listed |
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy P.F.C. E Knee System Stabilized All-Polyethylene Tibia, 71mm M/L, 47mm A/P, 15.0mm, 3, UHMWPE, sterile; REF Product Code/96-2643. Terminated |
NJL | None listed |
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy P.F.C. E Knee System Stabilized All-Polyethylene Tibia, 76mm M/L, 51mm A/P, 8.0mm, 4, UHMWPE, sterile; Product Code/REF 96-2650. Terminated |
NJL | None listed |
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy P.F.C. E Knee System Stabilized All-Polyethylene Tibia, 76mm M/L, 51mm A/P, 12.5mm, 4, UHMWPE, sterile; Product Code/REF 96-2652. Terminated |
NJL | None listed |
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy P.F.C. E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 64 mm M/L, 43 mm A/P, 15 mm, 2, UHMWPE, sterile; Product Code/REF 96-2712. Terminated |
NJL | None listed |
| Dec 6, 2007 | Depuy Orthopaedics, Inc. Depuy P.F.C. E Knee System Stabilized Plus Tibial Insert (STAB PLUS), 64 mm M/L, 43 mm A/P, 17.5 mm, 2, UHMWPE, sterile; Product Code/REF 96-2713. Terminated |
NJL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.