ClearanceBrief
510(k) K961685 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

P.F.C. CRUCIATE RETAINING KNEE SYSTEM (SIZE 1.5)

ApplicantJohnson & Johnson Professionals, Inc., Raynham MA, US
DecisionSubstantially Equivalent, Jul 10, 1996
ReceivedMay 1, 1996
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K961685

DateFirm and productCodeLinked 510(k)
Oct 21, 2006Depuy Orthopaedics, Inc.
Depuy PFC Oval Dome Patella (Part Number 960100)3-Peg, 32 mm, sterile; REF 96-0100.
Terminated		 JWHNone listed
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 2.5, 8 mm; Ref 97-0340.
Terminated		 JWHNone listed
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 3, 12.5 mm; Ref 97-0352.
Terminated		 JWHNone listed
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 3, 15.0 mm; Ref 97-0353.
Terminated		 JWHNone listed
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 4, 10 mm; Ref 97-0361.
Terminated		 JWHNone listed
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 5, 10.0 Ref 97-0371.
Terminated		 JWHNone listed
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy SIGMA curved plus insert; polyethylene tibial insert, Sz 5, 15.0 mm; Ref 97-0373.
Terminated		 JWHNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.