Panels › Orthopedic › Product code KWY · Class 2
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
Regulation 888.3390
1510(k)s in 12 months (99 all time)
0recalls in 12 months (88 all time)
86recalls that name a 510(k)
Top companies in KWY
| Company | 510(k)s | Recalls |
|---|---|---|
| Biomet, Inc. | 5 | 20 |
| Omni Life Science, Inc. | 1 | 23 |
| Encore Medical, Lp | 0 | 18 |
| Johnson & Johnson Professionals, Inc. | 9 | 0 |
| Ortho Development Corp. | 5 | 3 |
| Zimmer | 5 | 3 |
| Wright Medical Technology Inc | 0 | 7 |
| Zimmer Biomet, Inc. | 0 | 5 |
| 3M Company | 4 | 0 |
| Exactech, Inc. | 3 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 49 mm OD
Product Code: H3-82849.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 48 mm OD
Product Code: H3-82848.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 47 mm OD
Product Code: H3-82847.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 46 mm OD
Product Code: H3-82846.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 45 mm OD
Product Code: H3-82845.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head Bipolar Head, 28 mm ID, 44 mm OD
Product Code: H3-82844.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplas Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head, 22.225mm ID, 43 mm OD
Product Code: H3-82243.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head, 22.225mm ID, 42 mm OD
Product Code: H3-82242.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head, 22.225mm ID, 41 mm OD
Product Code: H3-82241.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head, 22.225mm ID, 40 mm OD
Product Code: H3-82240.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head, 22.225mm ID, 39 mm OD
Product Code: H3-82239.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the Terminated |
KWY | K082468 |
| Sep 10, 2009 | Omni Life Science Apex Hip System Bipolar Head, 22.225mm ID, 38 mm OD
Product Code: H3-82238.
Intended for use in combination with an Apex Hip System femoral for uncemented primary or revision hemiarthroplasty of the Terminated |
KWY | K082468 |
| Sep 11, 2008 | Stryker Howmedica Osteonics Corp. Scorpio Total Knee Posteriorly Stabilized Femoral Component, #7R, Catalog No.: 71-4107R, Lot Code: K05L310; Scorpio Total Knee Posteriorly Stabilized Femoral Component, #7L, Catalog No. 71-4506L, Lot Terminated |
KWY | K962152 |
| Nov 7, 2007 | Encore Medical, Lp Foundation Hip System Bipolar Modular, Size 60mm OD; Cat. #412-01-060; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWY | K953510 |
| Nov 7, 2007 | Encore Medical, Lp Foundation Hip System Bipolar Modular, Size 58mm OD; Cat. #412-01-058; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWY | K953510 |
| Nov 7, 2007 | Encore Medical, Lp Foundation Hip System Bipolar Modular, Size 56mm OD; Cat. #412-01-056; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWY | K953510 |
| Nov 7, 2007 | Encore Medical, Lp Foundation Hip System Bipolar Modular, Size 54mm OD; Cat. #412-01-054; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWY | K953510 |
| Nov 7, 2007 | Encore Medical, Lp Foundation Hip System Bipolar Modular, Size 53mm OD; Cat. #412-01-053; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWY | K953510 |
| Nov 7, 2007 | Encore Medical, Lp Foundation Hip System Bipolar Modular, Size 52mm OD; Cat. #412-01-052; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWY | K953510 |
| Nov 7, 2007 | Encore Medical, Lp Foundation Hip System Bipolar Modular, Size 51mm OD; Cat. #412-01-051; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWY | K953510 |
| Nov 7, 2007 | Encore Medical, Lp Foundation Hip System Bipolar Modular, Size 50mm OD; Cat. #412-01-050; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWY | K953510 |
| Nov 7, 2007 | Encore Medical, Lp Foundation Hip System Bipolar Modular, Size 49mm OD; Cat. #412-01-049; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWY | K953510 |
| Nov 7, 2007 | Encore Medical, Lp Foundation Hip System Bipolar Modular, Size 48mm OD; Cat. #412-01-048; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWY | K953510 |
| Nov 7, 2007 | Encore Medical, Lp Foundation Hip System Bipolar Modular, Size 47mm OD; Cat. #412-01-047; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWY | K953510 |
| Nov 7, 2007 | Encore Medical, Lp Foundation Hip System Bipolar Modular, Size 46mm OD; Cat. #412-01-046; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWY | K953510 |
| Nov 7, 2007 | Encore Medical, Lp Foundation Hip System Bipolar Modular, Size 45mm OD; Cat. #412-01-045; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWY | K953510 |
| Nov 7, 2007 | Encore Medical, Lp Foundation Hip System Bipolar Modular, Size 44mm OD; Cat. #412-01-044; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWY | K953510 |
| Nov 7, 2007 | Encore Medical, Lp Foundation Hip System Bipolar Modular, Size 43mm OD; Cat. #412-01-043; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWY | K953510 |
| Nov 7, 2007 | Encore Medical, Lp Foundation Hip System Bipolar Modular, Size 42mm OD; Cat. #412-01-042; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWY | K953510 |
| Nov 7, 2007 | Encore Medical, Lp Foundation Hip System Bipolar Modular, Size 41mm OD; Cat. #412-01-041; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWY | K953510 |
| Nov 7, 2007 | Encore Medical, Lp Foundation Hip System Bipolar Modular, Size 40mm OD; Cat. #412-01-040; Sterile; assembly required by physician prior to implant; manufactured by Encore Medical, L.P., Austin, TX 78758. Terminated |
KWY | K953510 |
| Mar 7, 2007 | Wright Medical Technology Inc Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3655, Size 55mm O.D., use with 36 mm Head Terminated |
KWY | None listed |
| Mar 7, 2007 | Wright Medical Technology Inc Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3654, Size 54mm O.D., use with 36 mm Head Terminated |
KWY | K062693 |
| Mar 7, 2007 | Wright Medical Technology Inc Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3653, Size 53mm O.D., use with 36 mm Head Terminated |
KWY | K062693 |
| Mar 7, 2007 | Wright Medical Technology Inc Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3652, Size 52mm O.D., use with 36 mm Head Terminated |
KWY | K062693 |
| Mar 7, 2007 | Wright Medical Technology Inc Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3651, Size 51mm O.D., use with 36 mm Head Terminated |
KWY | K062693 |
| Mar 7, 2007 | Wright Medical Technology Inc Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-3650, Size 50mm O.D., use with 36 mm Head Terminated |
KWY | K062693 |
| Mar 7, 2007 | Wright Medical Technology Inc Wright Medical Technology, Gladiator Bipolar Hip Prosthesis, REF: GLBP-2241, Size 41mm O.D., use with 22 mm Head Terminated |
KWY | K062693 |
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