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)
Top companies in JDI
| Company | 510(k)s | Recalls |
|---|---|---|
| Zimmer Biomet | 1 | 92 |
| Biomet, Inc. | 51 | 18 |
| Zimmer, Inc. | 27 | 23 |
| Depuy, Inc. | 45 | 0 |
| Howmedica Corp. | 43 | 0 |
| Stryker Howmedica Osteonics | 0 | 37 |
| DePuy Orthopaedics, Inc. | 12 | 20 |
| Osteonics Corp. | 29 | 0 |
| Howmedica Osteonics | 17 | 11 |
| Intermedics Orthopedics | 21 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 12, 2010 | Stryker Howmedica Osteonics Corp. Stryker Orthopaedics, Accolade Distal Centralizer 14 mm Large; Catalog No.: 1059-6714. For use with Accolade hip prosthesis. Terminated |
JDI | K974054 |
| Nov 20, 2009 | Smith & Nephew Inc Oxinium Femoral Head, 36 MM OD-3, 12/14 Taper, REF 71343603, Sterile, Smith & Nephew, Memphis TN 38116 Terminated |
JDI | K030766 |
| Jul 23, 2009 | Zimmer 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 |
JDI | K040389 |
| Jul 23, 2009 | Zimmer 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 |
JDI | K001733 |
| Jan 26, 2009 | Stryker 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 |
JDI | K020989 |
| Jan 26, 2009 | Stryker 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 |
JDI | K983226 |
| Jan 26, 2009 | Stryker 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 |
JDI | K983226 |
| Jan 26, 2009 | Stryker 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 |
JDI | K031744 |
| Sep 17, 2008 | Biomet, 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 |
JDI | K052685 |
| Aug 26, 2008 | Encore 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 |
JDI | K000817 |
| Apr 22, 2008 | Stryker 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 |
JDI | None listed |
| Feb 26, 2008 | Stryker 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 |
JDI | K952970 |
| Feb 26, 2008 | Stryker 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 |
JDI | K952970 |
| Feb 26, 2008 | Stryker 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 |
JDI | K952970 |
| Feb 26, 2008 | Stryker 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 |
JDI | K952970 |
| Feb 26, 2008 | Stryker 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 |
JDI | K952970 |
| Feb 26, 2008 | Stryker 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 |
JDI | K952970 |
| Feb 26, 2008 | Stryker 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 |
JDI | K952970 |
| Feb 26, 2008 | Stryker 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 |
JDI | K952970 |
| Feb 26, 2008 | Stryker 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 |
JDI | K952970 |
| Feb 26, 2008 | Stryker 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 |
JDI | K952970 |
| Feb 26, 2008 | Stryker 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 |
JDI | K952970 |
| Feb 7, 2008 | Stryker 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 |
JDI | None listed |
| Feb 7, 2008 | Stryker 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 |
JDI | None listed |
| Feb 7, 2008 | Stryker 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 |
JDI | None listed |
| Feb 7, 2008 | Stryker 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 |
JDI | None listed |
| Feb 7, 2008 | Stryker 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 |
JDI | None listed |
| Feb 7, 2008 | Stryker 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 |
JDI | None listed |
| Feb 7, 2008 | Stryker 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 |
JDI | None listed |
| Feb 7, 2008 | Stryker 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 |
JDI | None listed |
| Feb 7, 2008 | Stryker 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 |
JDI | K010757 |
| Jul 23, 2007 | Encore 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 |
JDI | K000817 |
| Jul 23, 2007 | Encore 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 |
JDI | K000817 |
| Jul 23, 2007 | Encore 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 |
JDI | K000817 |
| Jul 23, 2007 | Encore 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 |
JDI | K000817 |
| Feb 16, 2006 | Wright Medical Technology Inc Guardian Distal Femur Axial Pin Terminated |
JDI | K013035 |
| Sep 21, 2005 | Linvatec 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 |
JDI | K020377 |
| Sep 21, 2005 | Linvatec 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 |
JDI | K983136 |
| Sep 21, 2005 | Linvatec 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 |
JDI | K042778 |
| Sep 21, 2005 | Linvatec 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 |
JDI | K033804 |
| Aug 3, 2005 | Zimmer Inc. Zimmer brand Versys Hip System Femoral Head 12/14 taper, 32 mm dia., neck length +0mm; Product 00-8018-032-02. Terminated |
JDI | K953337 |
| Aug 24, 2004 | Wright Medical Technology Inc Guardian Distal Femur Axial Pin Terminated |
JDI | K013035 |
| Jul 22, 2004 | Encore Medical, Lp HA Hip Stem, cementless Terminated |
JDI | K993943 |
| Sep 24, 2003 | Biomet, Inc. Stanmore modular hip system; Stanmore CoCr femoral size 5 straight stem; part 164255 Terminated |
JDI | K911684 |
| Sep 24, 2003 | Biomet, Inc. Stanmore modular hip system; Stanmore CoCr femoral size 4 straight stem; part 164254 Terminated |
JDI | K911684 |
| Sep 24, 2003 | Biomet, Inc. Stanmore modular hip system; Stanmore CoCr femoral size 3 straight stem; part 164253 Terminated |
JDI | K911684 |
| Sep 24, 2003 | Biomet, Inc. Stanmore modular hip system; Stanmore CoCr femoral size 2 straight stem; part 164252 Terminated |
JDI | K911684 |
| Sep 24, 2003 | Biomet, Inc. Stanmore modular hip system; Stanmore CoCr femoral size 1 straight stem; part 164251 Terminated |
JDI | K911684 |
| Sep 24, 2003 | Biomet, Inc. Stanmore modular hip system; Stanmore CoCr femoral size 5 std. stem; part 164245 Terminated |
JDI | K911684 |
| Sep 24, 2003 | Biomet, Inc. Stanmore modular hip system; Stanmore CoCr femoral size 4 std. stem; part 164244 Terminated |
JDI | K911684 |
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