ClearanceBrief
510(k) K952830 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

DARWIN KNEE SYSTEM (TC3)

ApplicantJohnson & Johnson Professionals, Inc., Raritan NJ, US
DecisionSubstantially Equivalent for Some Indications, Jan 18, 1996
ReceivedJun 20, 1995
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K952830

DateFirm and productCodeLinked 510(k)
Jul 18, 2018DePuy Orthopaedics, Inc.
P.F.C. SIGMA Revision Knee System Distal Augment, Model Number 960830
Terminated		 JWHNone listed
Dec 6, 2007Depuy Orthopaedics, Inc.
Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 12.5mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0521.
Terminated		 NJLNone listed
Dec 6, 2007Depuy Orthopaedics, Inc.
Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 15.0mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0522.
Terminated		 NJLNone listed
Dec 6, 2007Depuy Orthopaedics, Inc.
Depuy P.F.C. E Knee System Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 17.5mm, 67 mm M/L, 45 mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0523.
Terminated		 NJLNone listed
Dec 6, 2007Depuy Orthopaedics, Inc.
Depuy P.F.C. E Knee System TC3 Tibial Insert, 2.5, 30.0mm, 67mm M/L, 45 mm A/P, 30.0 mm, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0527.
Terminated		 NJLNone listed
Dec 6, 2007Depuy Orthopaedics, Inc.
Depuy P.F.C. E Knee System TC3 Tibial Insert, 4, 20.0mm, 75mm M/L, 51mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0544.
Terminated		 NJLNone listed
Dec 6, 2007Depuy Orthopaedics, Inc.
Depuy P.F.C. E Knee System TC3 Tibial Insert, 5, 12.5mm, 83mm M/L, 55mm A/P, UHMWPE/Ti-6AI-4V, sterile; Product Code/REF 96-0551.
Terminated		 NJLNone listed
Aug 24, 2004Depuy Orthopaedics, Inc.
P.F.C. Knee System 7 Fluted Femoral Stem 18mmX125mm REF 96-1703
Terminated		 JWHNone listed

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