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)
1recalls 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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 13, 2026 | K253357 | b-ONE® Bipolar Head B-One Ortho, Corp. | KWY |
| Aug 25, 2025 | K243634 | Maxx Libertas Bipolar Hip Head (Bipolar Hip) Maxx Orthopedics, Inc. | KWY |
| Dec 19, 2023 | K231526 | CORAIL Cemented Femoral Stem Depuy Ireland UC, IE | KWY |
| Mar 23, 2023 | K223441 | SpaceFlex Acetabular Cup G21, S.R.L., IT | KWY |
| Jul 20, 2022 | K221794 | Vario-Cup System Waldemar Link GmbH & Co. KG, DE | KWY |
| Mar 23, 2022 | K220492 | COPAL exchange G hip spacer Heraeus Medical GmbH, DE | KWY |
| Apr 17, 2020 | K200709 | Kyocera Bipolar Hip System Kyocera Medical Technologies, Inc. | KWY |
| Nov 5, 2019 | K192236 | Fitmore Hip Stem Zimmer GmbH, CH | KWY |
| Nov 1, 2019 | K191016 | COPAL exchange G Hip and Knee Spacers Heraeus Medical GmbH, DE | KWY |
| Sep 17, 2019 | K191297 | iNSitu Bipolar Hip System Theken Companies, LLC | KWY |
| Aug 28, 2019 | K191569 | Implantcast ic-Bipolar Head System Implantcast GmbH, DE | KWY |
| Jun 5, 2019 | K183114 | Corin BiPolar-i Corin U.S.A. Limited | KWY |
| Jun 14, 2018 | K173455 | SurgTech Bipolar Head System Surgtech, Inc. | KWY |
| Feb 23, 2018 | K180130 | ELEOS Bipolar Acetabular System Onkos Surgical, Inc. | KWY |
| Jan 29, 2018 | K163081 | 40-42mm BiPolar Head and 22mm Femoral Head Signature Orthopaedics Pty, Ltd., AU | KWY |
| Feb 7, 2017 | K170072 | Fitmore® Hip Stem Zimmer GmbH, CH | KWY |
| Apr 7, 2016 | K152439 | U2 Bipolar Implant and 22mm Femoral Head United Orthopedic Corporation, TW | KWY |
| Jan 28, 2015 | K143113 | Klassic BiPolar System Total Joint Orthopedics | KWY |
| Feb 7, 2014 | K132539 | RING-LOK MODULAR BIPOLAR SYSTEM Implants International, Ltd. | KWY |
| Sep 19, 2013 | K131354 | RENOVIS BIPOLAR HIP SYSTEM Renovis Surgical Technologies, LLC | KWY |
| Sep 16, 2013 | K123991 | DEPUY CORAIL AMT HIP PROSTHESIS Depuy France S.A.S. | KWY |
| Nov 5, 2012 | K121509 | TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT Tgm Medical, Inc. | KWY |
| Oct 12, 2011 | K112019 | BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP Corentec Co., Ltd., KR | KWY |
| Dec 3, 2010 | K100761 | BIOPRO POLAR HEAD Biopro, Inc. | KWY |
| Oct 8, 2010 | K101670 | UNITED U2 BIPOLAR IMPLANT United Orthopedic Corp., TW | KWY |
| May 28, 2010 | K100151 | APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM) Omnlife Science | KWY |
| Mar 2, 2010 | K091967 | MEDACTA BIPOLAR HEAD Medacta International S.A. | KWY |
| Feb 18, 2009 | K082468 | APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60) Omni Life Science, Inc. | KWY |
| Dec 15, 2008 | K082705 | BIOPRO BIPOLAR HEAD, MODELS 18130-18152 Biopro, Inc. | KWY |
| Oct 31, 2008 | K080979 | STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT Biomet Manufacturing Corp | KWY |
| Jul 8, 2008 | K080647 | ACCIN BIPOLAR HEAD SYSTEM Accelerated Innovation, LLC | KWY |
| Sep 29, 2006 | K062693 | GLADIATOR BIPOLAR SYSTEM Wrightmedicaltechnologyinc | KWY |
| May 31, 2006 | K060707 | AESCULAP BIPOLAR ACETABULAR CUP Aesculap, Inc. | KWY |
| Dec 16, 2005 | K052990 | STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEM Biomet, Inc. | KWY |
| Aug 29, 2005 | K050269 | U1 HIP SYSTEM - BIPOLAR United Orthopedic Corp., TW | KWY |
| Jul 7, 2005 | K050966 | PIVOT BIPOLAR FEMORAL HEAD Ortho Development Corp. | KWY |
| Aug 27, 2004 | K040947 | DURASUL BIPOLAR Centerpulse Orthopedics, Inc. | KWY |
| Jan 23, 2003 | K023743 | SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM Smith & Nephew, Inc. | KWY |
| Mar 8, 2002 | K014072 | FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH) Disc-O-Tech Medical Technologies, Ltd. | KWY |
| Dec 5, 2001 | K013211 | MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS Exactech, Inc. | KWY |
| Feb 5, 2001 | K010081 | ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS Exactech, Inc. | KWY |
| Dec 15, 2000 | K003363 | M2A 32MM TAPER SYSTEM Biomet, Inc. | KWY |
| Sep 10, 1999 | K991990 | TRI-POLAR SYSTEM Biomet, Inc. | KWY |
| Dec 4, 1998 | K982812 | G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER) Johnson & Johnson Professionals, Inc. | KWY |
| Nov 25, 1998 | K982447 | PLUS BIPOLAR PROSTHESIS COCRMO Plus Orthopedics | KWY |
| Oct 7, 1998 | K982389 | ODC B2 BIPOLAR CUP Ortho Development Corp. | KWY |
| Aug 21, 1998 | K981238 | BIPOLAR FEMORAL HEAD Whiteside Biomechanics, Inc. | KWY |
| May 29, 1998 | K980801 | J-FX BIPOLAR HEAD Johnson & Johnson Professionals, Inc. | KWY |
| Apr 30, 1997 | K970447 | IMPLEX BIPOLAR HIP SYSTEM Implex Corp. | KWY |
| Apr 21, 1997 | K970284 | ARTOS, DIPLOS SYSTEM Turnkey Intergration USA, Inc. | KWY |
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