ClearanceBrief
Panels › Orthopedic › Product code JWH · Class 2

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Regulation 888.3560

15510(k)s in 12 months (922 all time)
7recalls in 12 months (985 all time)
888recalls that name a 510(k)
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Top companies in JWH

Company510(k)sRecalls
Zimmer, Inc.51304
DePuy Orthopaedics, Inc.16102
Smith & Nephew, Inc.4960
Exactech, Inc.3264
Howmedica Osteonics3261
Zimmer Biomet, Inc.085
Biomet, Inc.4044
Stryker Howmedica Osteonics064
Conformis, Inc.4019
Encore Medical L.P.1544
DateFirm and productCodeLinked 510(k)
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 5, 10 mm; Ref 1581-15-010.
Terminated		 JWHK033272
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 5, 8 mm; Ref 1581-15-008.
Terminated		 JWHK033272
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 4, 17.5 mm; Ref 1581-14-017.
Terminated		 JWHK033272
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 4, 15 mm; Ref 1581-14-015.
Terminated		 JWHK033272
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 4,10 mm; Ref 1581-14-010.
Terminated		 JWHK033272
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 4, 8 mm; Ref 1581-14-008.
Terminated		 JWHK033272
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 3, 20 mm; Ref 1581-13-020.
Terminated		 JWHK033272
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 3, 17.5 mm; Ref 1581-13-017.
Terminated		 JWHK033272
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 3, 15 mm; Ref 1581-13-015.
Terminated		 JWHK033272
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 3, 10 mm; Ref 1581-13-010.
Terminated		 JWHK033272
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 3, 8 mm; Ref 1581-13-008.
Terminated		 JWHK033272
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 2.5, 17.5 mm; Ref 1581-12-017.
Terminated		 JWHK033272
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 2.5, 10 mm; Ref 1581-12-010.
Terminated		 JWHK033272
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert , Sz 2.5, 8 mm; Ref 1581-12-008.
Terminated		 JWHK033272
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy P.F.C. SIGMA curved insert; polyethylene tibial insert, Sz 2, 8 mm; Ref 1581-11-008.
Terminated		 JWHK033272
Jun 22, 2005Plus Orthopedics USA
Cancellous Bone Screw, 6.5 x 50 mm, Model 0214807
Terminated		 JWHK022204
Feb 15, 2005Plus Orthopedics
UltraCongruent Tibial Insert Model 0214703 Tibial Insert, Ultra-Congruent, Right, Size 3, 10mm
Terminated		 JWHK022204
Feb 3, 2005Stelkast Co
Proven Porous CR Femur. Implantable orthopedic device
Terminated		 JWHK002281
Dec 23, 2004Exactech, Inc.
Cemented Trapezoid Tibial Tray Sz. 4F/4T, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
Terminated		 JWHK933610
Aug 24, 2004Depuy Orthopaedics, Inc.
P.F.C. Knee System 7 Fluted Femoral Stem 18mmX130mm REF: 96-1731
Terminated		 JWHNone listed
Aug 24, 2004Depuy Orthopaedics, Inc.
P.F.C. Knee System 7 Fluted Femoral Stem 18mmX125mm REF 96-1703
Terminated		 JWHK952830
Aug 24, 2004Depuy Orthopaedics, Inc.
P.F.C. Modular Knee System Modular Plus Tibial Wedge 10 HEMI x 8.5MM HEIGHT Product Code: 86-0178
Terminated		 JWHK923807
Jul 20, 2004Encore Medical, LP
3DKnee System, Stemmed Tibia-Nonporous-3D, Size 6, Right, sterile. Manufactured by Encore Orthopeadics, 9800 Metric Blvd., Austin, Texas 78758
Terminated		 JWHK020114
Jul 20, 2004Encore Medical, LP
Foundation Knee System, Tibia-Nonporous, Size 6, Right, sterile. Manufactured by Encore Orthopeadics, 9800 Metric Blvd., Austin, Texas 78758
Terminated		 JWHK923277
Nov 27, 2003Plus Orthopedics
TC-PLUS Solution Femoral Component Size 12L, part 21041-C, lot 0006.13.2635.
Terminated		 JWHNone listed
Oct 15, 2003Ortho Development Corporation
Guide pin (component of the Tibial Punch Guide) of the Balanced Knee System.
Terminated		 JWHNone listed
Jul 30, 2003Encore Medical, LP
Foundation Knee System, non-porous Femur Size 8, Right
Terminated		 JWHK923277
May 21, 2003Stryker Howmedica Osteonics
Interax Knee Midi 1 Tibial Inserts. IX HC Tib Ins Midi 1 14mm R.
Terminated		 JWHK973121
May 21, 2003Stryker Howmedica Osteonics
Interax Knee Midi 1 Tibial Inserts. IX HC Tib Ins Midi 1 14mm L.
Terminated		 JWHK973121
May 21, 2003Stryker Howmedica Osteonics
Interax Knee Midi 1 Tibial Inserts. IX HC Tib Ins Midi 1 10mm L.
Terminated		 JWHK973121
May 21, 2003Stryker Howmedica Osteonics
Interax Knee Midi 1 Tibial Inserts. Interax Tib Ins Midi 1 10 Rgt.
Terminated		 JWHK973121
May 21, 2003Stryker Howmedica Osteonics
Interax Knee Midi 1 Tibial Inserts. IX HC Tib Bear Ins M1 14mm R.
Terminated		 JWHK973121
May 21, 2003Stryker Howmedica Osteonics
Interax Knee Midi 1 Tibial Inserts. Interax Tib Ins Midi 1 10mm Lft.
Terminated		 JWHK973121
May 21, 2003Stryker Howmedica Osteonics
Interax Knee Midi 1 Tibial Inserts. Interax Tib Ins Midi 1 8mm Lft.
Terminated		 JWHK973121
May 21, 2003Stryker Howmedica Osteonics
Interax Knee Midi 1 Tibial Inserts. Interax Tib Ins Midi 1 6mm Lft.
Terminated		 JWHK973121

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