ClearanceBrief
Product code NJL ยท Class 3

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

0510(k)s in 12 months (0 all time)
0recalls in 12 months (269 all time)
59recalls that name a 510(k)
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Top companies in NJL

Company510(k)sRecalls
DePuy Orthopaedics, Inc.0251
Zimmer Biomet, Inc.011
Zimmer Inc.05
Exactech, Inc.01
ZIMMER ORTHOPEDIC MFG LTD01
DateFirm and productCodeLinked 510(k)
Dec 6, 2007Depuy Orthopaedics, Inc.
Depuy P.F.C. E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 10 mm, Size 4, UHMWPE, sterile; Product Code/REF 96-2141.
Terminated
NJLNone listed
Dec 6, 2007Depuy Orthopaedics, Inc.
Depuy P.F.C. E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 17.5 mm, Size 3, UHMWPE, sterile; Product Code/REF 96-2134.
Terminated
NJLNone listed
Dec 6, 2007Depuy Orthopaedics, Inc.
Depuy P.F.C. E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 15 mm, Size 3, UHMWPE, sterile; Product Code/REF 96-2133.
Terminated
NJLNone listed
Dec 6, 2007Depuy Orthopaedics, Inc.
Depuy P.F.C. E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 12.5 mm, Size 3, UHMWPE, sterile; Product Code/REF 96-2132.
Terminated
NJLNone listed
Dec 6, 2007Depuy Orthopaedics, Inc.
Depuy P.F.C. E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 10 mm, Size 3, UHMWPE, sterile; Product Code/REF 96-2131.
Terminated
NJLNone listed
Dec 6, 2007Depuy Orthopaedics, Inc.
Depuy P.F.C. E RP Knee System Rotating Platform Stabilized Tibial Insert (RP-STAB), 12.5mm, Size 2.5, UHMWPE, sterile; Product Code/REF 96-2122.
Terminated
NJLNone listed
Dec 6, 2007Depuy Orthopaedics, Inc.
Depuy P.F.C. E RP Knee System Rotating Platform Curved Tibial Insert (RP-CVD), 10mm, Size 4, UHMWPE, sterile; Product Code/REF 96-2041.
Terminated
NJLNone listed
Dec 6, 2007Depuy 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
NJLK943462
Dec 6, 2007Depuy 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
NJLK943462
Dec 6, 2007Depuy 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
NJLK943462
Dec 6, 2007Depuy 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
NJLK943462
Dec 6, 2007Depuy 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
NJLK943462
Dec 6, 2007Depuy 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
NJLK943462
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
NJLK952830
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
NJLK952830
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
NJLK952830
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
NJLK952830
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
NJLK952830
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
NJLK952830
Dec 6, 2007Depuy 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
NJLK950010
Dec 6, 2007Depuy 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
NJLK950010
Dec 6, 2007Depuy 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
NJLK950010
Dec 6, 2007Depuy 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
NJLK950010
Dec 6, 2007Depuy 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
NJLK950010
Dec 6, 2007Depuy 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
NJLK950010
Dec 6, 2007Depuy 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
NJLK950010
Dec 6, 2007Depuy 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
NJLK950010
Dec 6, 2007Depuy 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
NJLK950010
Dec 6, 2007Depuy 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
NJLK950010
Dec 6, 2007Depuy 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
NJLK950010
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy P.F.C. E Knee System, stabilized plus tibial insert (STAB PLUS); polyethylene tibial insert, Sz 3, 12.5 mm; Ref 96-2731.
Terminated
NJLNone listed
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy P.F.C. E Knee System, stabilized plus tibial insert (STAB PLUS); polyethylene tibial insert, Sz 3, 10 mm; Ref 96-2730.
Terminated
NJLNone listed
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy P.F.C. E Knee System, stabilized plus tibial insert (STAB PLUS); polyethylene tibial insert, Sz 2.5, 25 mm; Ref 96-2726.
Terminated
NJLNone listed
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy P.F.C. E Knee System, stabilized plus tibial insert (STAB PLUS); polyethylene tibial insert, Sz 2.5, 20 mm; Ref 96-2724.
Terminated
NJLNone listed
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy P.F.C. E Knee System, stabilized plus tibial insert (STAB PLUS); polyethylene tibial insert, Sz 2, 22.5 mm; Ref 96-2715.
Terminated
NJLNone listed
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy P.F.C. E Knee System, stabilized plus tibial insert (STAB PLUS); polyethylene tibial insert, Sz 2, 10 mm; Ref 96-2710.
Terminated
NJLNone listed
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy P.F.C. E Knee System, stabilized all-polyethylene tibia; polyethylene tibial insert, Sz 1.5, 12.5 mm; Ref 96-2612.
Terminated
NJLNone listed
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy P.F.C. E Knee System, stabilized tibial insert (STAB); polyethylene tibial insert, Sz 2.5, 10.0 mm; Ref 96-0431.
Terminated
NJLNone listed
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy SIGMA RP TC3 insert; polyethylene tibial insert, Sz 5, 25.0 mm; Ref 96-2367.
Terminated
NJLNone listed
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy SIGMA RP TC3 insert; polyethylene tibial insert, Sz 5, 22.5 mm; Ref 96-2366.
Terminated
NJLNone listed
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy SIGMA RP TC3 insert; polyethylene tibial insert, Sz 5, 17.5 mm; Ref 96-2364.
Terminated
NJLNone listed
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy SIGMA RP TC3 insert; polyethylene tibial insert, Sz 5, 12.5 mm; Ref 96-2362.
Terminated
NJLNone listed
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy SIGMA RP TC3 insert; polyethylene tibial insert, Sz 4, 25.0 mm; Ref 96-2357.
Terminated
NJLNone listed
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy SIGMA RP TC3 insert; polyethylene tibial insert, Sz 3, 30.0 mm; Ref 96-2348.
Terminated
NJLNone listed
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy SIGMA RP TC3 insert; polyethylene tibial insert, Sz 3, 25.0 mm; Ref 96-2347.
Terminated
NJLNone listed
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy SIGMA RP TC3 insert; polyethylene tibial insert, Sz 3, 22.5 mm; Ref 96-2346.
Terminated
NJLNone listed
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy SIGMA RP TC3 insert; polyethylene tibial insert, Sz 2.5, 30.0 mm; Ref 96-2338.
Terminated
NJLNone listed
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy SIGMA RP TC3 insert; polyethylene tibial insert, Sz 2.5, 10.0 mm; Ref 96-2331.
Terminated
NJLNone listed
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy SIGMA RP TC3 insert; polyethylene tibial insert, Sz 2, 15.0 mm; Ref 96-2323.
Terminated
NJLNone listed
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy P.F.C. E Knee System, stabilized plus tibial insert; polyethylene tibial insert, Sz 6, 20 mm; Ref 96-2764.
Terminated
NJLNone listed

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