ClearanceBrief
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

DateFirm and productCodeLinked 510(k)
May 14, 2012Zimmer Inc.
90595202017, NexGen Complete Knee Solution, Prolong, Highly Crosslinked Polyethylene Micro Articular Surface with locking screw & insert, Size Purple/A E Micro 17 mm Height; Sterile, Rx ,Zimmer, Inc
Terminated
JWHK003910
K892800 +2
May 14, 2012Zimmer Inc.
00-5976-020-23 NexGen Complete Knee Solution, Prolong, Highly Crosslinked Polyethylene Micro Articular Surface with locking screw & insert, Size Purple/A E Micro 23 mm Height; Sterile, Rx ,Zimmer, I
Terminated
JWHK003910
K892800 +2
May 14, 2012Zimmer Inc.
90595202012, NexGen CompleteKnee Solution, Prolong, Highly Crosslinked Polyethylene Micro Articular Surface with locking screw & insert, Size Purple/A E Micro 12 mm Height; Sterile, Rx ,Zimmer, Inc.
Terminated
JWHK003910
K892800 +2
May 14, 2012Zimmer Inc.
00-5970-02023, NexGen CompleteKnee Solution, Prolong, Highly Crosslinked Polyethylene Micro Articular Surface with locking screw & insert, Size Purple/A E Micro 23mm Height; Sterile, Rx ,Zimmer, Inc
Terminated
JWHK003910
K892800 +2
May 14, 2012Zimmer Inc.
00595202020, NexGen CompleteKnee Solution, Prolong, Highly Crosslinked Polyethylene Micro Articular Surface Size Purple/A E Micro 20 mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Artic
Terminated
JWHK003910
K892800 +2
May 14, 2012Zimmer Inc.
00595202017, NexGen CompleteKnee Solution, Prolong, Highly CrossLinked Polyethylene Micro Articular Surface Size Purple/A E Micro 17 mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Artic
Terminated
JWHK003910
K892800 +2
May 14, 2012Zimmer Inc.
00595202014, NexGen CompleteKnee Solution, Prolong, Highly CrossLinked Polyethylene Micro Articular Surface Size Purple/A E Micro 14mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articu
Terminated
JWHK003910
K892800 +2
May 14, 2012Zimmer Inc.
00595202012, NexGen CompleteKnee Solution, Prolong, Highly CrossLinked Polyethylene Micro Articular Surface Size Purple/A E Micro 12mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articu
Terminated
JWHK003910
K892800 +2
May 14, 2012Zimmer Inc.
00595202010, NexGen CompleteKnee Solution, Prolong, Highly CrossLinked Polyethylene Micro Articular Surface Size Purple/A E Micro 10mm Height; Sterile, Rx ,Zimmer, Inc. Warsaw, IN The NexGen Articu
Terminated
JWHK003910
K892800 +2
Mar 2, 2012Biomet, Inc.
REF 42-422561 SIGNATURE QTY, 1 TKA GDE/MDL (Prosthesis, knee) SET 04-05 DGHUMPHR-NOV52LKA-J_K-00432022 SLIDEX DISTAL-MP/PREMIER TIBIAL CUSTOM-MADE DEVICE Signature Personalized Patient Care System is
Terminated
JWHK102795
Feb 21, 2012Aesculap Implant Systems
Columbus Tibia Plateau (component of the Columbus REVISION Knee System) Product Usage - The Columbus Revision Knee System is indicated for use in reconstruction of the diseased knee joint caused by o
Terminated
JWHK083772
Jan 25, 2012Zimmer Inc.
Natural-Knee II Durasul All-Poly Patella, Size 3, 10mm The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed componen
Terminated
JWHK002335
Jan 25, 2012Zimmer Inc.
Natural-Knee II Durasul All-Poly Patella, Size 2, 10mm The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed componen
Terminated
JWHK002335
Jan 25, 2012Zimmer Inc.
Natural-Knee II Durasul All-Poly Patella, Size 1, 10mm The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed componen
Terminated
JWHK002335
Jan 25, 2012Zimmer Inc.
Natural-Knee II Durasul All-Poly Patella, Size 0, 10mm The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed componen
Terminated
JWHK002335
Jan 25, 2012Zimmer Inc.
Natural-Knee II Durasul All-Poly Patella, Size 3, 7mm The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed component
Terminated
JWHK002335
Jan 25, 2012Zimmer Inc.
Natural-Knee II Durasul All-Poly Patella, Size 2, 7mm The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed component
Terminated
JWHK002335
Jan 25, 2012Zimmer Inc.
Natural-Knee II Durasul All-Poly Patella, Size 1, 7mm The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed component
Terminated
JWHK002335
Jan 25, 2012Zimmer Inc.
Natural-Knee II Durasul All-Poly Patella, Size 0, 7mm The Zimmer Natural-Knee II Durasul Patella product is a semi-constrained total knee prosthesis consisting of four anatomically designed component
Terminated
JWHK002335
Jan 11, 2012Biomet, Inc.
Biomet Series A Asymmetrical Patella size 28mm, three pegs - 184791, Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee. Joint patellofemoroti
Terminated
JWHK040770
Jan 11, 2012Biomet, Inc.
Biomet Series A Asymmetrical Patella size 25mm, three pegs - 184790, Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee. Joint patellofemoroti
Terminated
JWHK040770
Jan 11, 2012Biomet, Inc.
Biomet Series A Thin Patella size 28mm, three pegs - 184782, Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee joint patellofemorotibial, ceme
Terminated
JWHK040770
Jan 11, 2012Biomet, Inc.
Biomet Series A Standard Patella size 28mm, three pegs - 184762, Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee joint patellofemorotibial,
Terminated
JWHK040770
Jan 11, 2012Biomet, Inc.
Biomet Series A Standard Patella size 25mm, three pegs - 184760, Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee joint patellofemorotibial,
Terminated
JWHK040770
Jan 11, 2012Biomet, Inc.
Biomet Series A Thin Patella size 25mm, one peg - 184720, Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee joint patellofemorotibial, cemente
Terminated
JWHK040770
Jan 11, 2012Biomet, Inc.
Biomet Series A Thin Patella size 25mm, one peg - 184720 Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems Knee joint patellofemorotibial, cemented
Terminated
JWHK040770
Jan 11, 2012Biomet, Inc.
Biomet Series A Standard Patella size 28mm, one peg - 184702, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & ACG Knee system. Knee joint patellofemorotibial, cemented,
Terminated
JWHK040770
Jan 11, 2012Biomet, Inc.
Biomet Series A Standard Patella size 25mm, one peg, Part 184700, Sterile, Biomet Orthopedics, Warsaw, IN 46582 Knee joint patellofemorotibial, cemented, polymer/metal/polymer, semi-constrained. For
Terminated
JWHK040770
Jan 11, 2012Biomet, Inc.
Biomet Series A Thin Patella size 25mm, three pegs, Part 184780, Sterile, Biomet Orthopedics, Warsaw, IN 46582 For use with Vanguard, Maxim, Ascent & AGC Knee Systems. Knee joint patellofemorotibia
Terminated
JWHK040770
Dec 2, 2011Encore Medical, Lp
Foundation Tibial Broach P/N 801-01-013 Foundation Tibial Broach to be used in conjunction with the Tibial Sizing Template and Tibial Broach Guide to prepare the resected tibial plateau for accepta
Terminated
JWHK970031
Aug 30, 2011DePuy Orthopaedics, Inc.
PFC Sigma Round Dome Patella 38 MM 3 Peg Device is indicated for use in knee replacement procedures in conjunction with femoral knee prosthesis components and polymethylmethacrylate (PMMA) bone cemen
Terminated
JWHK884796
Aug 4, 2011Biomet, Inc.
Vanguard PS Open Box Femoral 70 MM Left Interlock, " FOR CEMENTED USE ONLY" CO-CR-MO ALLOY. Biomet, Inc. A knee joint replacement prosthesis non-coated femoral indicated for cemented application onl
Terminated
JWHK023546
Apr 28, 2011Biomet, Inc.
Biomet Interlok 67 MM fixed Cruciate Tibial Plate with locking bar CO-CR-MO/TI 6AL 4V ALLOY, REF 141232, Sterile, BIOMET ORTHOPEDICS, WARSAW. IN I-Beam Tibia Plates are knee joint replacement prosth
Terminated
JWHNone listed
Apr 28, 2011Biomet, Inc.
Biomet Interlok 75 MM fixed I-Beam Tibial Plate with locking bar CO-CR-MO/TI 6AL 4V ALLOY, REF 141224, Sterile, BIOMET ORTHOPEDICS, WARSAW. IN I-Beam Tibia Plates are knee joint replacement prosthes
Terminated
JWHK915132
Mar 16, 2011Stryker Howmedica Osteonics Corp.
SCORPIO CR TIBIAL TRIAL, non sterile, made in the USA Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. The Tibial trial are utilized during surgery to assess the overall component f
Terminated
JWHNone listed
Feb 11, 2011Stryker Howmedica Osteonics Corp.
Triathlon Femoral Distal Fixation Peg; Catalog Number 5575-X-00; Manufactured by Stryker Howmedica Osteonics Corp., Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA A Subsidiary o
Terminated
JWHK031729
Jan 7, 2011Ortho Development Corporation
UC Tibial Insert, Size 4, 12mm, REF 163-3412, Sterile R, Ortho Development, Draper, Utah 84020 The tibial insert is a device that fits into the tibial tray during knee revision. It provides the base
Terminated
JWHK060569
Jan 7, 2011Ortho Development Corporation
CR Tibial Insert, Size 5, 7mm, REF 163-2507, Sterile R, Ortho Development, Draper, Utah 84020. The tibial insert is a device that fits into the tibial tray during knee revision. It provides the base
Terminated
JWHK060569
Jan 7, 2011Ortho Development Corporation
UC Tibial Insert, Size 4, 13mm, REF 163-3413, Sterile R, Ortho Development, Draper, Utah 84020. The tibial insert is a device that fits into the tibial tray during knee revision. It provides the base
Terminated
JWHK060569
Dec 2, 2010Zimmer Inc.
Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size E Right, sterile, REF 00-5764-015-52.
Terminated
JWHK060370
K960279
Dec 2, 2010Zimmer Inc.
Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size E Left, sterile, REF 00-5764-015-51.
Terminated
JWHK060370
K960279
Dec 2, 2010Zimmer Inc.
Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size F Right, sterile, REF 00-5764-016-52.
Terminated
JWHK060370
K960279
Dec 2, 2010Zimmer Inc.
Zimmer, NexGen Complete Knee Solution LPS Flex Gender Femoral Component, Size G Left, sterile, REF 00-5764-017-51.
Terminated
JWHK060370
K960279
Dec 2, 2010Zimmer Inc.
Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size E Right, sterile, REF 00-5996-015-02.
Terminated
JWHK060370
K960279
Dec 2, 2010Zimmer Inc.
Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size F Right, sterile, REF 00-5996-016-02.
Terminated
JWHK060370
K960279
Dec 2, 2010Zimmer Inc.
Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size F Left, sterile, REF 00-5996-016-01.
Terminated
JWHK060370
K960279
Dec 2, 2010Zimmer Inc.
Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size G Right, sterile, REF 00-5996-017-02.
Terminated
JWHK060370
K960279
Dec 2, 2010Zimmer Inc.
Zimmer, NexGen Complete Knee Solution LPS Femoral Component, Size G Left, sterile, REF 00-5996-017-01.
Terminated
JWHK060370
K960279
Oct 21, 2010Zimmer Inc.
NexGen Complete Knee Solution Stemmed Tibial Component Precoat Size 3, REF 00-5980-037-01, Sterile, Zimmer, Warsaw, IN. Intended for mating with a UHMWPE articular surface and Zimaloy Cobalt-Chromium
Terminated
JWHK933785
Oct 21, 2010Zimmer Inc.
NexGen Complete Knee Solution Stemmed Tibial Component Precoat Size 6, REF 00-5980-047-02, Sterile, Zimmer, Warsaw, IN. Intended for mating with a UHMWPE articular surface and Zimaloy Cobalt-Chromiu
Terminated
JWHK933785

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