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Panels › Orthopedic › Product code JWH · Class 2

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

Regulation 888.3560

14510(k)s in 12 months (921 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)
Jan 23, 2008Stelkast Co
StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number SC2287-4-5, Size 4, Thickness 5 mm, StelKast, Murray, PA 15317
Terminated		 JWHK051976
Jan 23, 2008Stelkast Co
StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number SC2287-3-5, Size 3, Thickness 5 mm, StelKast, Murray, PA 15317
Terminated		 JWHK051976
Jan 23, 2008Stelkast Co
StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number SC2287-2-5, Size 2 Thickness 5 mm, StelKast, Murray, PA 15317
Terminated		 JWHK051976
Jan 23, 2008Stelkast Co
StelKast Proven Knee System - Tibial Half Block Augmentation and Screw. Part Number SC2287-1-5, Size 1, Thickness 5 mm, StelKast, Murray, PA 15317
Terminated		 JWHK051976
Dec 11, 2007Stryker Howmedica Osteonics Corp.
Triathlon MIS Modular Capture;Catalog Number: 6541-5-723; Stryker Orthopaedics, Mahwah, New Jersey
Terminated		 JWHNone listed
Dec 11, 2007Stryker Howmedica Osteonics Corp.
Triathlon MIS Femoral Adjustment Block;Catalog Number: 6541-5-601;Stryker Orthopaedics, Mahwah, New Jersey
Terminated		 JWHNone listed
Dec 11, 2007Stryker Howmedica Osteonics Corp.
Triathlon MIS AP Sizer Body - Left and Right; Catalog Number: 6541-5-508- left; Catalog Number: 6541-5-509 - right, Stryker Orthopaedics, Mahwah, New Jersey
Terminated		 JWHNone listed
Dec 8, 2007Plus Orthopedics USA
VKS Tibial Trial, Right/Left, Prep Guide; Model Number: 1214331, 1214332, 1214333, 1214334, 1214335: ( Model Number: 1214331 VKS Tibial Prep Guide, Right/Left, Size 1, Lot Code EM. 1 and EM.6; 121433
Terminated		 JWHNone listed
Dec 8, 2007Plus Orthopedics USA
VKS PE Tibia Insert Ultra-Congruent; Left, Size 2, 12mm; Model Number: 0214612; Plus Orthopedics, San Diego, CA 92121
Terminated		 JWHK022204
Dec 5, 2007Biomet, Inc.
Biomet Orthopedics, Vanguard PS Open Box Femoral, 67.5 mm Left-Interlok, For Cemented Use Only, CO-CR-MO Alloy, REF 183130, Knee Prosthesis Component, Biomet Orthopedics, Inc., Warsaw, IN 46581
Terminated		 JWHK023546
Nov 24, 2007Biomet, Inc.
Biomet Interlok 67 mm Fixed Cruciate Tibial Plate with Locking Bar; CO-CR-MO/TI 6AL 4V Alloy; Product Number/REF 141232, Biomet Orthopedics, Inc., Warsaw, IN 46582
Terminated		 JWHK915132
Oct 31, 2007Biomet, Inc.
Biomet Orthopedics DCM AGC Molded Tibial Component, 12 mm thick x 80 mm, UHMWPE/CO-CR-MO alloy, sterile; REF 155116.
Terminated		 JWHK921182
Oct 31, 2007Biomet, Inc.
Biomet --DCM AGC Molded Tibial Implant (12 mm x 80 mm)--Biomet Orthopedics , Interlok finish/posterior stabilized, 12 mm thick x 80 mm wide, UHMWPE/CO-CR-MO alloy, sterile; REF 155364, Biomet Orthope
Terminated		 JWHK921182
Sep 25, 2007Stryker Howmedica Osteonics Corp.
Triathlon X3 Total Stabilizer + Tibial Insert For use with Triathlon Universal Baseplates, knee prosthesis. #5 13mm Stryker Orthopaedics
Terminated		 JWHK070095
Sep 21, 2007Stryker Howmedica Osteonics Corp.
Duracon Total Knee Modular Femoral Component; Non-Porous Right Medium Assembly, Product No. 6632-0-325
Terminated		 JWHK920034
Mar 28, 2007Zimmer Inc.
NexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral Finishing Guide, instrumentation used in total knee arthroplasty procedures. Catalog No. 82015272522.
Terminated		 JWHNone listed
Mar 28, 2007Zimmer Inc.
NexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral Finishing Guide, instrumentation used in total knee arthroplasty procedures. Catalog No. 82015272521.
Terminated		 JWHNone listed
Mar 28, 2007Zimmer Inc.
NexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral Finishing Guide, instrumentation used in total knee arthroplasty procedures. Catalog No. 82015272520.
Terminated		 JWHNone listed
Mar 28, 2007Zimmer Inc.
NexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral Finishing Guide, instrumentation used in total knee arthroplasty procedures. Catalog No. 82015272519.
Terminated		 JWHNone listed
Mar 28, 2007Zimmer Inc.
NexGen Complete Knee Solution Minimally Invasive Solutions MIS Technology Femoral Finishing Guide, instrumentation used in total knee arthroplasty procedures. Catalog No. 82015272518.
Terminated		 JWHNone listed
Feb 27, 2007Exactech, Inc.
Polyethylene tibial posterior stabilized components. Optetrak All Poly Tibial PS Component. Knee prosthesis. Catalog number : 204-11-13
Terminated		 JWHK933494
Feb 8, 2007Stryker Howmedica Osteonics Corp.
Triathlon X3 CR Tibial Bearing Insert Size #7 - 11MM Ref # 5530-G-711 2011-09 Howmedica Osteonics Corp.
Terminated		 JWHK051146
Feb 8, 2007Stryker Howmedica Osteonics Corp.
Triathlon X3 CR Tibial Bearing Insert for knee prosthesis Size #2 - 11MM Ref # 5530-G-211 2011-09 Howmedica Osteonics Corp.
Terminated		 JWHK051146
Nov 22, 2006Zimmer Inc.
Zimmer NexGen Complete Knee Solution Legacy Knee Tibial Component, 3 degree, fluted, size 4, stemmed option, for cemented use only, tivanium TI-6AL-4V alloy/UHMWPE, sterile; Catalog no. 05-5998-038-02
Terminated		 JWHK963148
Nov 21, 2006Exactech, Inc.
Optetrak, B-series cemented finned tibial tray size 2f/2t. Catalog # 220-04-02
Terminated		 JWHK010434
Oct 21, 2006Depuy Orthopaedics, Inc.
Depuy PFC Oval Dome Patella (Part Number 960100)3-Peg, 32 mm, sterile; REF 96-0100.
Terminated		 JWHK961685
Jun 2, 2006Exactech, Inc.
Product is Optetrak Cemented Finned Tibial Tray Sz. 4F/5T. Knee prosthesis. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P53 mm M/L 83mm***STERILE, SINGLE USE ONLY FOR CEMENTED USE O
Terminated		 JWHK932776
Jan 18, 2006Plus Orthopedics USA
VKS Knee System; VKS Distal Femoral Resection Guide, Model Number 1214122, Revisions A and B. (Re-usable surgical instrument)
Terminated		 JWHK022204
Dec 29, 2005Encore Medical, Lp
Size 8 right 3DKnee Non-porous Baseplates (Catalog #333-02-108) joint knee replacement.
Terminated		 JWHK020114
Dec 29, 2005Encore Medical, Lp
Size 6 right Foundation Total Knee System (Catalog #324-01-106) knee joint replacement.
Terminated		 JWHK923277
Nov 3, 2005Plus Orthopedics USA
TC-PLUS Solution Femoral Component, model 21028, Femoral component, right, size 8.
Terminated		 JWHK000666
Oct 15, 2005Stryker Howmedica Osteonics Corp.
Scorpio Total Knee Cruciate Retaining Femoral Component, #7, right, Catalog No. 70-4107R. Manuf. by Stryker Orthopaedics, Mahwah, NJ, 1 each to a package.
Terminated		 JWHK974556
Oct 15, 2005Stryker Howmedica Osteonics Corp.
Scorpio Total Knee Cruciate Retaining Femoral Component, #7, left, Catalog No. 70-4107L. Manuf. by Stryker Orthopaedics, Mahwah, NJ, 1 each to a package.
Terminated		 JWHK974556
Oct 7, 2005Plus Orthopedics USA
TC-PLUS Tibial Insert UC 10; 11mm, Model 25457
Terminated		 JWHK000666
Oct 7, 2005Plus Orthopedics USA
TC-PLUS Tibial Insert UC 6; 13mm, Model 25438
Terminated		 JWHK000666
Oct 7, 2005Plus Orthopedics USA
TC-PLUS Tibial Insert UC 6; 9 mm, Model 25436
Terminated		 JWHK000666
Oct 7, 2005Plus Orthopedics USA
TC-PLUS Tibial Insert UC 4; 13mm, Model 25428
Terminated		 JWHK000666
Oct 7, 2005Plus Orthopedics USA
TC-PLUS Tibial Insert UC 4; 11mm, Model 25427
Terminated		 JWHK000666
Oct 7, 2005Plus Orthopedics USA
TC-PLUS Tibial Insert 2; 15mm, Model 25309
Terminated		 JWHK000666
Oct 7, 2005Plus Orthopedics USA
TC-PLUS Tibial Insert Ultra-Congruent Size 10 ; 9 mm, Model 25456
Terminated		 JWHK000666
Sep 21, 2005Encore Medical, Lp
Encore Reverse Shoulder Prosthesis (RSP), manufactured and distributed by Encore Medical, L.P. 9800 Metric Blvd., Austin, Texas 78758
Terminated		 JWHK041066
Aug 18, 2005Exactech, Inc.
The product is a Finned Tibial Tray. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P 53 mm ML 83mm***4F/5T Ti Alloy FITS ONLY SZ. 4 FEMORAL CEMENTED***STERILE, SINGLE USE ONLY. FOR CE
Terminated		 JWHK932776
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy P.F.C. Modular Knee System, constrained tibial insert (CONST); polyethylene tibial insert, Sz 6, 12.5 mm; Ref 98-6571.
Terminated		 JWHNone listed
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy P.F.C. Modular Knee System, constrained tibial insert (CONST); polyethylene tibial insert, Sz 5, 22.5 mm; Ref 98-6565.
Terminated		 JWHNone listed
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy P.F.C. Modular Knee System, constrained tibial insert (CONST); polyethylene tibial insert, Sz 4, 12.5 mm; Ref 98-6551.
Terminated		 JWHNone listed
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy P.F.C. Modular Knee System, stabilized tibial insert (STAB); polyethylene tibial insert, Sz 6, 22.5 mm; Ref 98-6096.
Terminated		 JWHNone listed
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy P.F.C. Modular Knee System, stabilized tibial insert (STAB); polyethylene tibial insert, Sz 5, 25.0 mm; Ref 98-6087.
Terminated		 JWHNone listed
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy P.F.C. Modular Knee System, stabilized tibial insert (STAB); polyethylene tibial insert, Sz 5, 12.5 mm; Ref 98-6082.
Terminated		 JWHNone listed
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy P.F.C. Modular Knee System, stabilized tibial insert (STAB); polyethylene tibial insert, Sz 4, 10.0 mm; Ref 98-6071.
Terminated		 JWHNone listed
Aug 12, 2005Depuy Orthopaedics, Inc.
Depuy P.F.C. Modular Knee System, stabilized tibial insert (STAB); polyethylene tibial insert, Sz 3, 17.5 mm; Ref 98-6064.
Terminated		 JWHNone listed

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