510(k) K884796 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
P.F.C.(TM) MODULAR KNEE SYSTEM
| Applicant | Johnson & Johnson Professionals, Inc., Raynham MA, US |
| Decision | Substantially Equivalent for Some Indications, Mar 29, 1989 |
| Received | Nov 16, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884796
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 30, 2011 | DePuy Orthopaedics, Inc. PFC Sigma Round Dome Patella 38 MM 3 Peg
Device is indicated for use in knee replacement procedures in conjunction with femoral knee prosthesis components and polymethylmethacrylate (PMMA) bone cemen Terminated |
JWH | None listed |
| Aug 12, 2005 | Depuy Orthopaedics, Inc. Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 1, 10.0 mm; Ref 98-4031. Terminated |
JWH | None listed |
| Aug 12, 2005 | Depuy Orthopaedics, Inc. Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 2, 12.5 mm; Ref 98-4144. Terminated |
JWH | None listed |
| Aug 12, 2005 | Depuy Orthopaedics, Inc. Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 2, 10.0 mm; Ref 98-4143. Terminated |
JWH | None listed |
| Aug 12, 2005 | Depuy Orthopaedics, Inc. Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 2, 8.0 mm; Ref 98-4142. Terminated |
JWH | None listed |
| Aug 12, 2005 | Depuy Orthopaedics, Inc. Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 4, 8.0 mm; Ref 98-4152. Terminated |
JWH | None listed |
| Aug 12, 2005 | Depuy Orthopaedics, Inc. Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 3, 17.5 mm; Ref 98-4151. Terminated |
JWH | None listed |
| Aug 12, 2005 | Depuy Orthopaedics, Inc. Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 4, 12.5 mm; Ref 98-4154. Terminated |
JWH | None listed |
| Aug 12, 2005 | Depuy Orthopaedics, Inc. Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 5, 10.0 mm; Ref 98-4158. Terminated |
JWH | None listed |
| Aug 12, 2005 | Depuy Orthopaedics, Inc. Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 5, 8.0 mm; Ref 98-4157. Terminated |
JWH | None listed |
| Aug 12, 2005 | Depuy Orthopaedics, Inc. Depuy P.F.C. Modular Knee System, curved tibial insert (CVD); polyethylene tibial insert, Sz 6, 15.0 mm; Ref 98-4198. Terminated |
JWH | None listed |
| Aug 12, 2005 | Depuy Orthopaedics, Inc. Depuy P.F.C. Modular Knee System, posterior-lipped tibial insert (PLI); polyethylene tibial insert, Sz 3, 12.5 mm; Ref 98-4610. Terminated |
JWH | None listed |
| Aug 12, 2005 | Depuy Orthopaedics, Inc. Depuy P.F.C. Modular Knee System, posterior-lipped tibial insert (PLI); polyethylene tibial insert, Sz 4, 12.5 mm; Ref 98-4618. Terminated |
JWH | None listed |
| Aug 12, 2005 | Depuy Orthopaedics, Inc. Depuy P.F.C. Modular Knee System, posterior-lipped tibial insert (PLI); polyethylene tibial insert, Sz 5, 10.0 mm; Ref 98-4624. Terminated |
JWH | None listed |
| Aug 12, 2005 | Depuy Orthopaedics, Inc. Depuy P.F.C. Modular Knee System, posterior-lipped tibial insert (PLI); polyethylene tibial insert, Sz 5, 8.0 mm; Ref 98-4623. Terminated |
JWH | None listed |
| Aug 12, 2005 | Depuy Orthopaedics, Inc. Depuy P.F.C. Modular Knee System, posterior-lipped tibial insert (PLI); polyethylene tibial insert, Sz 5, 15.0 mm; Ref 98-4626. Terminated |
JWH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.