ClearanceBrief
Panels › Orthopedic › Product code JDI · Class 2

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

Regulation 888.3350

3510(k)s in 12 months (565 all time)
0recalls in 12 months (255 all time)
161recalls that name a 510(k)
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Top companies in JDI

DateFirm and productCodeLinked 510(k)
May 12, 2010Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics, Accolade Distal Centralizer 14 mm Large; Catalog No.: 1059-6714. For use with Accolade hip prosthesis.
Terminated
JDIK974054
Nov 20, 2009Smith & Nephew Inc
Oxinium Femoral Head, 36 MM OD-3, 12/14 Taper, REF 71343603, Sterile, Smith & Nephew, Memphis TN 38116
Terminated
JDIK030766
Jul 23, 2009Zimmer Inc.
Zimmer Coonrad/Morrey total elbow cement restrictor with nozzle, 1 - 16 mm, 1 - 25 mm, sterile, Zimmer, Dover, Ohio; Catatog Number: 32810503800. Total joint arthroplasy to control, restrict or imped
Terminated
JDIK040389
Jul 23, 2009Zimmer Inc.
Zimmer Allen medullary cement plugs, 1 - 20 dia. flange/10 mm dia. core, 1 - 24 mm dia. flange/12 mm dia. core (polyethylene with barium sulfate) with inserter, sterile, Zimmer, Warsaw, Indiana; Catat
Terminated
JDIK001733
Jan 26, 2009Stryker Howmedica Osteonics Corp.
Japanese Omnifit Eon 127 NK These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision to
Terminated
JDIK020989
Jan 26, 2009Stryker Howmedica Osteonics Corp.
Omnifit Eon These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthropl
Terminated
JDIK983226
Jan 26, 2009Stryker Howmedica Osteonics Corp.
Omnifit FC Cemented Stem These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total
Terminated
JDIK983226
Jan 26, 2009Stryker Howmedica Osteonics Corp.
Omnifit HFX Hip Stem These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip
Terminated
JDIK031744
Sep 17, 2008Biomet, Inc.
Biomet OSS (Orthopedic Salvage System) RS Non-Modular Long Tibial Base, 75mm x 10 x 160mm, Co-CR-MO/Ti-6AL-4V alloy, sterile; Part 161044. Implant is part of a system used to replace the tibial porti
Terminated
JDIK052685
Aug 26, 2008Encore Medical, Lp
Encore Modular Femoral Neck, 12 degree/35 mm; Ref #410-35-112; distributed by Encore Medical, Austin, TX 78758. Designed to ensure the proper anteversion and femoral head orientation in the acetabul
Terminated
JDIK000817
Apr 22, 2008Stryker Howmedica Osteonics Corp.
Stryker GMRS Proximal Femoral Surgical Protocol; Global Modular Replacement System Proximal Femoral Resection for Large Segmental Replacements, Femur Prosthesis Surgical Literature, Stryker Orthopaedi
Terminated
JDINone listed
Feb 26, 2008Stryker Howmedica Osteonics Corp.
Stryker Modular Replacement System Curved Cemented Stem; MRS 17x127 Curved Femoral Stem. Catalog Number: 6485-3-717; Stryker Orthopaedics Mahwah, NJ 07430
Terminated
JDIK952970
Feb 26, 2008Stryker Howmedica Osteonics Corp.
Stryker Modular Replacement System Curved Cemented Stem; MRS 15x127 Curved Femoral Stem. Catalog Number: 6485-3-715; Stryker Orthopaedics Mahwah, NJ 07430
Terminated
JDIK952970
Feb 26, 2008Stryker Howmedica Osteonics Corp.
Stryker Modular Replacement System Curved Cemented Stem; MRS 13x127 Curved Femoral Stem. Catalog Number: 6485-3-713; Stryker Orthopaedics Mahwah, NJ 07430
Terminated
JDIK952970
Feb 26, 2008Stryker Howmedica Osteonics Corp.
Stryker Modular Replacement System Curved Cemented Stem; MRS 11x127 Curved Femoral Stem. Catalog Number: 6485-3-711; Stryker Orthopaedics Mahwah, NJ 07430
Terminated
JDIK952970
Feb 26, 2008Stryker Howmedica Osteonics Corp.
Stryker Modular Replacement System Curved Cemented Stem; MRS 17mmx203 Femoral Stem. Catalog Number 6485-3-317; Stryker Orthopaedics Mahwah, NJ 07430
Terminated
JDIK952970
Feb 26, 2008Stryker Howmedica Osteonics Corp.
Stryker Modular Replacement System Curved Cemented Stem; MRS 15mmx203mm Femoral Stem. Catalog Number: 6485-3-315; Stryker Orthopaedics Mahwah, NJ 07430
Terminated
JDIK952970
Feb 26, 2008Stryker Howmedica Osteonics Corp.
Stryker Modular Replacement System Curved Cemented Stem; MRS 12mmx203 Femoral Stem. Catalog Number: 6485-3-313; Stryker Orthopaedics Mahwah, NJ 07430
Terminated
JDIK952970
Feb 26, 2008Stryker Howmedica Osteonics Corp.
Stryker Modular Replacement System Curved Cemented Stem; MRS 11mmx203mm femoral stem. Catalog Number: 6485-3-311; Stryker Orthopaedics Mahwah, NJ 07430
Terminated
JDIK952970
Feb 26, 2008Stryker Howmedica Osteonics Corp.
Stryker Modular Replacement System Curved Cemented Stem; MRS Small Curved Femoral Stem 9 x 102. Catalog Number: 6485-3-309; Stryker Orthopaedics Mahwah, NJ 07430
Terminated
JDIK952970
Feb 26, 2008Stryker Howmedica Osteonics Corp.
Stryker Modular Replacement System Curved Cemented Stem; MRS Small Curved Femoral Stem 8x102. Catalog Number 6485-3-308; Stryker Orthopaedics Mahwah, NJ 07430
Terminated
JDIK952970
Feb 26, 2008Stryker Howmedica Osteonics Corp.
Stryker Modular Replacement System Curved Cemented Stem; MRS SM Curved Femoral Stem 10x102; Catalog Number: 6485-3-300; Stryker Orthopaedics Mahwah, NJ 07430
Terminated
JDIK952970
Feb 7, 2008Stryker Howmedica Osteonics Corp.
Stryker Trial Head xx-Long (+16mm) Neck Length 32mm Diameter Sterile, Forged Vitallium Alloy; 6264-8-532; Howmedica Osteonics Corp. Styrker Ireland; Carrigtwohill county Cork, Ireland. Made in Ireland
Terminated
JDINone listed
Feb 7, 2008Stryker Howmedica Osteonics Corp.
Stryker Trial Head xx-Long (+16mm) Neck Length 28mm Diameter Sterile, Forged Vitallium Alloy; Product Number: 6264-8-528; Howmedica Osteonics Corp. Styrker Ireland; Carrigwohill Inustrial Estate; Carr
Terminated
JDINone listed
Feb 7, 2008Stryker Howmedica Osteonics Corp.
Stryker Trial Head xx-Long (+16mm) Neck Length 26mm Diameter Sterile, Forged Vitallium Alloy; Product Number 6264-8-526; Howmedica Osteonics Corp. Styrker Ireland; Carrigwohill Inustrial Estate; Carri
Terminated
JDINone listed
Feb 7, 2008Stryker Howmedica Osteonics Corp.
Stryker LFIT COCR V40 Femoral Head; xx-Long (+16mm) Neck Length 32mm Diameter Sterile, Forged Vitallium Alloy Product Number 6260-9-532 Howmedica Osteonics Corp. Styrker Ireland; Carrigtwohill county
Terminated
JDINone listed
Feb 7, 2008Stryker Howmedica Osteonics Corp.
Stryker LFIT COCR V40 Femoral Head; xx-Long (+16mm) Neck Length 28mm Diameter Sterile, Forged Vitallium Alloy; Product Number: 6260-9-528; Howmedica Osteonics Corp. Styrker Ireland; Carrigtwohill coun
Terminated
JDINone listed
Feb 7, 2008Stryker Howmedica Osteonics Corp.
Stryker LFIT COCR V40 Femoral Head; xx-Long (+16mm) Neck Length 26mm Diameter Sterile, Forged Vitallium Alloy; Product Number: 6260-9-526; Howmedica Osteonics Corp. Styrker Ireland; Carrigtwohill cou
Terminated
JDINone listed
Feb 7, 2008Stryker Howmedica Osteonics Corp.
Stryker COCR V40 Femoral Head; xx-Long (+16mm) Neck Length 32mm Diameter Sterile, Forged Vitallium Alloy; Product Number 6260-532; Howmedica Osteonics Corp. Styrker Ireland; Carrigtwohill county Cork,
Terminated
JDINone listed
Feb 7, 2008Stryker Howmedica Osteonics Corp.
Stryker COCR V40 Femoral Head; xx-Long (+16mm) Neck Length 28mm Diameter Sterile, Forged Vitallium Alloy; Product Number: 6260-9-528; Howmedica Osteonics Corp. Styrker Ireland; Carrigtwohill county Co
Terminated
JDINone listed
Feb 7, 2008Stryker Howmedica Osteonics Corp.
Stryker COCR V40 Femoral Head; xx-Long (+16mm) Neck Length, 26mm Diameter ; Sterile, Forged Vitallium Alloy, Product Number: 6260-5-526; Howmedica Osteonics Corp. Styrker Ireland; Carrigtwohill county
Terminated
JDIK010757
Jul 23, 2007Encore Medical, Lp
ALFA II Modular Femoral Right Modular Stem Porous Coated (Bowed); Size 6 Right; Length: 250mm; Distal Diameter: 18.0mm; Catalog #652-06-180R; component of the ENCORE Hip System; Single Use, Sterile; d
Terminated
JDIK000817
Jul 23, 2007Encore Medical, Lp
ALFA II Modular Femoral Left Modular Stem Porous Coated (Bowed); Size 6 Left; Length: 250mm; Distal Diameter: 18.0mm; Catalog #652-06-180L; component of the ENCORE Hip System; Single Use, Sterile; dis
Terminated
JDIK000817
Jul 23, 2007Encore Medical, Lp
ALFA II Modular Femoral Stem Pourous Coated; Size 7; Length 200mm; Distal Diameter: 19.5mm; Catalog #651-07-195; component of the ENCORE Hip System; Single Use, Sterile; distributed by Encore Medical
Terminated
JDIK000817
Jul 23, 2007Encore Medical, Lp
ALFA II Modular Femoral Revision Stem Porous Coated; Size 6; Length: 200mm; Diameter:18.0mm; Catalog #651-06-180; component of the ENCORE Hip System; Single Use, Sterile; distributed by Encore Medical
Terminated
JDIK000817
Feb 16, 2006Wright Medical Technology Inc
Guardian Distal Femur Axial Pin
Terminated
JDIK013035
Sep 21, 2005Linvatec Corp.
Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''REF*** QTY 1***Hornet Disposable Inserter, BioStinger Implant***STERILE***Linvatec, LINVATEC CORPORATION
Terminated
JDIK020377
Sep 21, 2005Linvatec Corp.
Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''REF C6120A QTY 1 BIO-ANCHOR, PRE-LOADED 3.5mm x 10.5 mm ***STERILE ***Linvatec, LINVATEC CORPORATION LAR
Terminated
JDIK983136
Sep 21, 2005Linvatec Corp.
Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''REF C6121H QTY 1 3.5 x 10.5 mm Bio-Anchor with Disposable Driver, Preloaded with One #2 Herculine Suture*
Terminated
JDIK042778
Sep 21, 2005Linvatec Corp.
Product is an Orthopedic device contained in a Peel Foil Pouch. Product is labeled in part: ''REF C6121 QTY 1 3.5mm Bio-Anchor with Disposable Driver***STERILE***Linvatec A ConMed Company LINVATEC CO
Terminated
JDIK033804
Aug 3, 2005Zimmer Inc.
Zimmer brand Versys Hip System Femoral Head 12/14 taper, 32 mm dia., neck length +0mm; Product 00-8018-032-02.
Terminated
JDIK953337
Aug 24, 2004Wright Medical Technology Inc
Guardian Distal Femur Axial Pin
Terminated
JDIK013035
Jul 22, 2004Encore Medical, Lp
HA Hip Stem, cementless
Terminated
JDIK993943
Sep 24, 2003Biomet, Inc.
Stanmore modular hip system; Stanmore CoCr femoral size 5 straight stem; part 164255
Terminated
JDIK911684
Sep 24, 2003Biomet, Inc.
Stanmore modular hip system; Stanmore CoCr femoral size 4 straight stem; part 164254
Terminated
JDIK911684
Sep 24, 2003Biomet, Inc.
Stanmore modular hip system; Stanmore CoCr femoral size 3 straight stem; part 164253
Terminated
JDIK911684
Sep 24, 2003Biomet, Inc.
Stanmore modular hip system; Stanmore CoCr femoral size 2 straight stem; part 164252
Terminated
JDIK911684
Sep 24, 2003Biomet, Inc.
Stanmore modular hip system; Stanmore CoCr femoral size 1 straight stem; part 164251
Terminated
JDIK911684
Sep 24, 2003Biomet, Inc.
Stanmore modular hip system; Stanmore CoCr femoral size 5 std. stem; part 164245
Terminated
JDIK911684
Sep 24, 2003Biomet, Inc.
Stanmore modular hip system; Stanmore CoCr femoral size 4 std. stem; part 164244
Terminated
JDIK911684

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