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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

DateFirm and productCodeLinked 510(k)
Oct 6, 2010Stryker Howmedica Osteonics Corp.
Duracon Total Knee Distal Femoral Locking Screw for 5 mm Spacer; Product No. 6632-5-600. Made in Ireland; Howmedica Osteonics; 325 Corporate Drive, Mahwah, NJ 07430 Intended for primary or secondar
Terminated
JWHK920034
Sep 20, 2010Zimmer Inc.
TRABECULAR METAL FEMORAL CONE AUGMENT - RIGHT, Part Number: 00-5450-012-32. The objective of the Trabecular Metal Femoral Cone Augment is to fill and reconstruct large bone deficiencies and cavitary
Terminated
JWHK040630
Sep 20, 2010Zimmer Inc.
TRABECULAR METAL FEMORAL CONE AUGMENT - LEFT, Part Number: 00-5450-012-31. The objective of the Trabecular Metal Femoral Cone Augment is to fill and reconstruct large bone deficiencies and cavitary
Terminated
JWHK040630
Sep 13, 2010Zimmer Inc.
NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 10, sterile, REF 00-5950-057-04, Zimmer Inc. Warsaw, IN. This device is indicated for patient
Terminated
JWHK043101
Sep 13, 2010Zimmer Inc.
NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 9, sterile, REF 00-5950-057-03, Zimmer Inc. Warsaw, IN. This device is indicated for patients
Terminated
JWHK043101
Sep 13, 2010Zimmer Inc.
NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 4+ (Plus), sterile, REF 00-5950-037-12, Zimmer Inc. Warsaw, IN. This device is indicated for
Terminated
JWHK043101
Sep 13, 2010Zimmer Inc.
NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 8, sterile, REF 00-5950-057-02, Zimmer Inc. Warsaw, IN. This device is indicated for patients
Terminated
JWHK043101
Sep 13, 2010Zimmer Inc.
NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 7 sterile, REF 00-5950-057-01, Zimmer Inc. Warsaw, IN. This device is indicated for patients
Terminated
JWHK043101
Sep 13, 2010Zimmer Inc.
NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 6, sterile, REF 00-5950-047-02, Zimmer Inc. Warsaw, IN. This device is indicated for patients
Terminated
JWHK043101
Sep 13, 2010Zimmer Inc.
NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 5, sterile, REF 00-5950-047-01, Zimmer Inc. Warsaw, IN. This device is indicated for patients
Terminated
JWHK043101
Sep 13, 2010Zimmer Inc.
NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 4, sterile, REF 00-5950-037-02, Zimmer Inc. Warsaw, IN. This device is indicated for patients
Terminated
JWHK043101
Sep 13, 2010Zimmer Inc.
NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 3, sterile, REF 00-5950-037-01, Zimmer Inc. Warsaw, IN. This device is indicated for patients
Terminated
JWHK043101
Sep 13, 2010Zimmer Inc.
NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 2, sterile, REF 00-5950-027-02, Zimmer Inc. Warsaw, IN. This device is indicated for patient
Terminated
JWHK043101
Sep 13, 2010Zimmer Inc.
NexGen complete knee solution MIS total knee procedure stemmed tibial component fixed bearing precoat size 1, sterile, REF 00-5950-027-01, Zimmer Inc. Warsaw, IN. This device is indicated for patients
Terminated
JWHK043101
Aug 31, 2010Stryker Howmedica Osteonics Corp.
Triathlon Total Knee System Primary Tibial Baseplate; Sterile, Made in Ireland. Howmedica Osteonics 325 Corporate Drive Mahwah, NJ 07430 The Triathlon system is comprised of a femoral component, tib
Terminated
JWHK031729
K040267
Aug 22, 2010Encore Medical, Lp
3DKnee Baseplates, Size 8, Left, Part # 333-01-108, Lot# A1000003.
Terminated
JWHK020114
Aug 10, 2010Biomet, Inc.
Biomet Vanguard CR femoral 57.5 mm left interlok, Sterile, REF 183022, Knee prosthesis component.
Terminated
JWHK023546
May 21, 2010Wright Medical Technology Inc
ADVANCE DURAMER TIBIAL INSERT, REF: KIMP-312R SIZE 3 RIGHT MEDIAL PIVOT, THICKNESS 12MM, 1 EACH, STERILE EO, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002. Indicated for use in
Terminated
JWHK972770
May 21, 2010Wright Medical Technology Inc
ADVANCE DURAMER TIBIAL INSERT, REF: KIMP-312L, SIZE 3 LEFT MEDIAL PIVOT, THICKNESS 12MM, 1 EACH, STERILE EO, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002. Indicated for use in k
Terminated
JWHK972770
May 20, 2010Endotec, Inc.
Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System. BP Ankle System, B-P Type II Talar Ankle Component: Size 1 B-P Type II Talar Ankle Component Catalog: 05-01-0101, Size 2 B-P Ty
Terminated
JWHK842234
K904870 +1
May 20, 2010Endotec, Inc.
TMJ Components: Right Ramus Component - DelCristo Catalog: 09-11-0215, TMJ - Shah Catalog: 09-42-0217, 09-11-0217. Left Fossa Component - DelCristo Catalog 09-42-0216, Left Ramus Component - DelCrist
Terminated
JWHNone listed
May 20, 2010Endotec, Inc.
Endotec Prothesis Ankle, Titanium Alloy, Sterilized, BP Ankle System. BP Ankle System, F-P Type III Ankle Bearing Component: 2x5mm F-P Type III Ankle Bearing Catalog: 05-13-0532, 2x7mm F-P Type III
Terminated
JWHK842234
K904870 +1
May 20, 2010Endotec, Inc.
Endotec Prothesis Ankle, Titanium Alloy, Sterilized. BP Ankle System, Talar Ankle Component: Size 2 Talar Component Catalog: 05-01-0002, Size 3 Talar Component Catalog: 05-01-0003, Size 4 Talar Com
Terminated
JWHK842234
K904870 +1
May 20, 2010Endotec, Inc.
Endotec Prothesis Hip, Titanium Alloy, Sterilized. Acetabular Bearing, BP Hip System Component: 32x54 Acetabular Bearing, Catalog: 01-02-3254, 32x56 Acetabular Bearing, Catalog: 01-02-3256, Femora
Terminated
JWHK963101
May 20, 2010Endotec, Inc.
Endotec Prosthesis Shoulder, Titanium Alloy, Sterilized Modular Femoral Stem BP Shoulder Component: 12mm Modular Femoral Stem, Catalog: 02-21-0103, Lot 02-21-0103ANN374.
Terminated
JWHK904880
May 20, 2010Endotec, Inc.
Endotec, Prosthesis Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer, Titanium Alloy, Sterilized, (Beuchel-Pappas (BP)) The B-P Knee Replacement System is composed of sev
Terminated
JWHK012702
Apr 26, 2010Encore Medical, Lp
3DKNEE SYSTEM, 3D Knee Tibial Insert-DCM, Sterile, Right, size 4 x 11mm. Encore Medical, LP. Austin, TX 78758-5445. Intended to aid the surgion in relieving the patient of knee pain and restoring k
Terminated
JWHK020114
Apr 7, 2010Encore Medical, Lp
Foundation Knee System, Patella Trial, 26 mm, part number 802-01-019, Lot number 53944551
Terminated
JWHK932246
Apr 5, 2010Ortho Development Corporation
5mm Tibial Augment Block, a component of Ortho Balanced Knee Modular Tibial System. The device is a component of Balanced Knee Modular Tibial System and is indicated for patients suffering from sever
Terminated
JWHK031201
Apr 5, 2010Ortho Development Corporation
10 degree Tibial Augment Wedge, a component of Ortho Balanced Knee Modular Tibial System. The device is a component of Balanced Knee Modular Tibial System and is indicated for patients suffering from
Terminated
JWHK031201
Mar 31, 2010Wright Medical Technology Inc
ADVANCE TIBIAL WEDGE AUGMENT, REF KTAG-W315, SIZE 3/2+, Thickness 15 DEG, SURFACE NON-POROUS, 1 EACH, Wright Medical Technology, 4677 Airline Road, Arlington, TN 38002. The device is intended for us
Terminated
JWHK973524
Mar 16, 2010Stryker Howmedica Osteonics Corp.
Howmedica Osteonics Corp., Scorpio NRG Femoral Size 7 Right; Knee prosthesis (Stryker France). Product Code: 814407R. Mahwah, NJ
Terminated
JWHK030978
Mar 10, 2010Zimmer Inc.
Zimmer NexGen Complete Knee Solution Minimally Invasive Solutions Procedures Trabecular Metal Technology Tibial Tray, fixed bearing, size 8, sterile, Zimmer, Warsaw, Indiana; REF 00-5954-057-02. The
Terminated
JWHK072160
Mar 2, 2010Zimmer Inc.
NextGen Knee Gender Solutions CR-Flex Femoral Component, Precoat , Size D, Left. 00-5750-014-01 Zimmer, Inc. Warsaw, IN.
Terminated
JWHK060370
Mar 2, 2010Stryker Howmedica Osteonics Corp.
Scorpio X3 UHMPWE Tibial Inserts and Scorpio X3 UHMWPE Patellar Components, multiple sizes, Stryker Orthopaedics, Mahwah, NJ. Intended to be used with cemented or cementless components in primary or
Terminated
JWHK051977
Mar 2, 2010Stryker Howmedica Osteonics Corp.
Triathlon X3 UHMWPE Tibial Inserts and Patellar Components, multiple sizes, Stryker Orthopaedics, Mahwah, NJ. Intended to be used with femoral components in primary or revision total knee arthroplast
Terminated
JWHK031729
Feb 24, 2010Encore Medical, Lp
Encore Medical Foundation Knee Revision Baseplate, Part Number 321-01-106, Size 6, Left
Terminated
JWHK932425
Feb 19, 2010Stryker Howmedica Osteonics Corp.
Scorpio PS Femoral Waffle (No post) and LFIT; Use only with Scorpio PS Tibial Bearing inserts and Scorpio Patellas, Stryker Orthopaedics. Intended for cemented application to replace the articulating
Terminated
JWHK962152
Feb 1, 2010Stryker Howmedica Osteonics Corp.
Triathlon Total Stabilizer Femoral Component; For Use with TS Components; Sterile, Made in the USA Stryker Orthopaedics, Mahwah, NJ 07430. The Triathlon Total Knee System components are intended fo
Terminated
JWHK070095
Feb 1, 2010Stryker Howmedica Osteonics Corp.
Triathlon Total Stabilizer Femoral Component; For Use with TS Components; Sterile, Made in the USA Stryker Orthopaedics, Mahwah, NJ 07430. The Triathlon Total Knee System components are intended fo
Terminated
JWHK070095
Feb 1, 2010Stryker Howmedica Osteonics Corp.
Triathlon Total Stabilizer Femoral Component; For Use with TS Components; Sterile, Made in the USA Stryker Orthopaedics, Mahwah, NJ 07430. The Triathlon Total Knee System components are intended fo
Terminated
JWHK070095
Feb 1, 2010Stryker Howmedica Osteonics Corp.
Triathlon Total Stabilizer Femoral Component; For Use with TS Components; Sterile, Made in the USA Stryker Orthopaedics, Mahwah, NJ 07430. The Triathlon Total Knee System components are intended for
Terminated
JWHK070095
Feb 1, 2010Stryker Howmedica Osteonics Corp.
Triathlon Total Stabilizer Femoral Component; Size # 2 for Use with TS Components; Sterile, Made in the USA Stryker Orthopaedics, Mahwah, NJ 07430. The Triathlon Total Knee System components are int
Terminated
JWHK070095
Jan 13, 2010Encore Medical, Lp
Foundation Tibia Baseplate, Catalog number 324-01-108. The tibial is modular in design, such that plastic inserts of various thicknesses and intramedullary stem are attached to the metal baseplate in
Terminated
JWHK932425
Dec 14, 2009Zimmer Inc.
Zimmer Gender Solutions Nexgen Complete Knee Solution, Legacy Knee- Posterior Stabilized, Gender Solutions Female, Femoral Component, option, LPS-flex, size C, right, for cemented use only; REF 00-57
Terminated
JWHK060370
Dec 1, 2009Stryker Howmedica Osteonics Corp.
Scorpio NRG Posterior Stabilized Femoral, #9 left; Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The Scorpio Femoral Components are a knee component that is utilized in total knee arth
Terminated
JWHK030978
Dec 1, 2009Stryker Howmedica Osteonics Corp.
Scorpio NRG Posterior Stabilized Femoral, # 7 left/right; Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The Scorpio Femoral Components are a knee component that is utilized in total kn
Terminated
JWHK030978
Dec 1, 2009Stryker Howmedica Osteonics Corp.
Scorpio NRG Posterior Stabilized Femoral, # 5 Left; Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07340. The Scorpio Femoral Components are a knee component that is utilized in total knee art
Terminated
JWHK030978
Dec 1, 2009Stryker Howmedica Osteonics Corp.
Scorpio NRG Posterior Stabilized Femoral. # 4 left/right; Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The Scorpio Femoral Components are a knee component that is utilized in total kn
Terminated
JWHK030978
Dec 1, 2009Stryker Howmedica Osteonics Corp.
Scorpio NRG Posterior Stabilized Femoral, #3 Left; Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The Scorpio Femoral Components are a knee component that is utilized in total knee arth
Terminated
JWHK030978

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