FDA Product Code
FDA Product Code KWY — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Orthopedic
- 21 CFR Citation
- 888.3390
510(k) Clearances — 99 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K253357 | b-ONE® Bipolar Head | B-One Ortho, Corp. | 2026-04-13 | Traditional | PDF ↗ |
| K243634 | Maxx Libertas Bipolar Hip Head (Bipolar Hip) | Maxx Orthopedics, Inc. | 2025-08-25 | Traditional | PDF ↗ |
| K231526 | CORAIL Cemented Femoral Stem | Depuy Ireland UC | 2023-12-19 | Traditional | PDF ↗ |
| K223441 | SpaceFlex Acetabular Cup | G21, S.R.L. | 2023-03-23 | Traditional | PDF ↗ |
| K221794 | Vario-Cup System | Waldemar Link GmbH & Co. KG | 2022-07-20 | Special | PDF ↗ |
| K220492 | COPAL exchange G hip spacer | Heraeus Medical GmbH | 2022-03-23 | Special | PDF ↗ |
| K200709 | Kyocera Bipolar Hip System | Kyocera Medical Technologies, Inc. | 2020-04-17 | Special | PDF ↗ |
| K192236 | Fitmore Hip Stem | Zimmer GmbH | 2019-11-05 | Special | PDF ↗ |
| K191016 | COPAL exchange G Hip and Knee Spacers | Heraeus Medical GmbH | 2019-11-01 | Traditional | PDF ↗ |
| K191297 | iNSitu Bipolar Hip System | Theken Companies, LLC | 2019-09-17 | Traditional | PDF ↗ |
| K191569 | Implantcast ic-Bipolar Head System | Implantcast GmbH | 2019-08-28 | Traditional | PDF ↗ |
| K183114 | Corin BiPolar-i | Corin U.S.A. Limited | 2019-06-05 | Traditional | PDF ↗ |
| K173455 | SurgTech Bipolar Head System | Surgtech, Inc. | 2018-06-14 | Traditional | PDF ↗ |
| K180130 | ELEOS Bipolar Acetabular System | Onkos Surgical, Inc. | 2018-02-23 | Traditional | PDF ↗ |
| K163081 | 40-42mm BiPolar Head and 22mm Femoral Head | Signature Orthopaedics Pty, Ltd. | 2018-01-29 | Traditional | PDF ↗ |
| K170072 | Fitmore® Hip Stem | Zimmer GmbH | 2017-02-07 | Special | PDF ↗ |
| K152439 | U2 Bipolar Implant and 22mm Femoral Head | United Orthopedic Corporation | 2016-04-07 | Traditional | PDF ↗ |
| K143113 | Klassic BiPolar System | Total Joint Orthopedics | 2015-01-28 | Traditional | PDF ↗ |
| K132539 | RING-LOK MODULAR BIPOLAR SYSTEM | Implants International, Ltd. | 2014-02-07 | Traditional | PDF ↗ |
| K131354 | RENOVIS BIPOLAR HIP SYSTEM | Renovis Surgical Technologies, LLC | 2013-09-19 | Traditional | PDF ↗ |
| K123991 | DEPUY CORAIL AMT HIP PROSTHESIS | Depuy France S.A.S. | 2013-09-16 | Traditional | PDF ↗ |
| K121509 | TREASURE BIPOLAR HEAD, FEMORAL HEAD, TREASURE BIPOLAR HEAD, INSERT | Tgm Medical, Inc. | 2012-11-05 | Traditional | PDF ↗ |
| K112019 | BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP | Corentec Co., Ltd. | 2011-10-12 | Traditional | PDF ↗ |
| K100761 | BIOPRO POLAR HEAD | Biopro, Inc. | 2010-12-03 | Traditional | PDF ↗ |
| K101670 | UNITED U2 BIPOLAR IMPLANT | United Orthopedic Corp. | 2010-10-08 | Traditional | PDF ↗ |
| K100151 | APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX (OD 38 TO 43MM), H3-828XX (OD44 TO 60MM) | Omnlife Science | 2010-05-28 | Traditional | PDF ↗ |
| K091967 | MEDACTA BIPOLAR HEAD | Medacta International S.A. | 2010-03-02 | Traditional | PDF ↗ |
| 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. | 2009-02-18 | Traditional | PDF ↗ |
| K082705 | BIOPRO BIPOLAR HEAD, MODELS 18130-18152 | Biopro, Inc. | 2008-12-15 | Traditional | PDF ↗ |
| K080979 | STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT | Biomet Manufacturing Corp | 2008-10-31 | Traditional | PDF ↗ |
| K080647 | ACCIN BIPOLAR HEAD SYSTEM | Accelerated Innovation, LLC | 2008-07-08 | Traditional | PDF ↗ |
| K062693 | GLADIATOR BIPOLAR SYSTEM | Wrightmedicaltechnologyinc | 2006-09-29 | Special | PDF ↗ |
| K060707 | AESCULAP BIPOLAR ACETABULAR CUP | Aesculap, Inc. | 2006-05-31 | Traditional | PDF ↗ |
| K052990 | STAGEONE DISPOSABLE CEMENT SPACER MOLD FOR TEMPORARY HIP PROSTHESIS WITH REINFORCEMENT STEM | Biomet, Inc. | 2005-12-16 | Traditional | PDF ↗ |
| K050269 | U1 HIP SYSTEM - BIPOLAR | United Orthopedic Corp. | 2005-08-29 | Traditional | PDF ↗ |
| K050966 | PIVOT BIPOLAR FEMORAL HEAD | Ortho Development Corp. | 2005-07-07 | Traditional | PDF ↗ |
| K040947 | DURASUL BIPOLAR | Centerpulse Orthopedics, Inc. | 2004-08-27 | Traditional | PDF ↗ |
| K023743 | SMITH & NEPHEW GLOBAL BIPOLAR SYSTEM | Smith & Nephew, Inc. | 2003-01-23 | Abbreviated | PDF ↗ |
| K014072 | FIXION UNIPOLAR MODULAR HEMI-HIP SYSTEM (FIXION UH) | Disc-O-Tech Medical Technologies, Ltd. | 2002-03-08 | Traditional | PDF ↗ |
| K013211 | MODIFICATION TO: ACUMATCH L-SERIES BIPOLAR ENDOPROSTHESIS | Exactech, Inc. | 2001-12-05 | Special | PDF ↗ |
| K010081 | ACUMATCH L-SERIES UNIPOLAR ENDOPROSTHESIS | Exactech, Inc. | 2001-02-05 | Special | PDF ↗ |
| K003363 | M2A 32MM TAPER SYSTEM | Biomet, Inc. | 2000-12-15 | Special | PDF ↗ |
| K991990 | TRI-POLAR SYSTEM | Biomet, Inc. | 1999-09-10 | Traditional | PDF ↗ |
| K982812 | G2 TOTAL HIP SYSTEM FEMORAL STEM (11/13 TAPER) | Johnson & Johnson Professionals, Inc. | 1998-12-04 | Traditional | PDF ↗ |
| K982447 | PLUS BIPOLAR PROSTHESIS COCRMO | Plus Orthopedics | 1998-11-25 | Traditional | PDF ↗ |
| K982389 | ODC B2 BIPOLAR CUP | Ortho Development Corp. | 1998-10-07 | Traditional | PDF ↗ |
| K981238 | BIPOLAR FEMORAL HEAD | Whiteside Biomechanics, Inc. | 1998-08-21 | Traditional | PDF ↗ |
| K980801 | J-FX BIPOLAR HEAD | Johnson & Johnson Professionals, Inc. | 1998-05-29 | Traditional | PDF ↗ |
| K970447 | IMPLEX BIPOLAR HIP SYSTEM | Implex Corp. | 1997-04-30 | Traditional | PDF ↗ |
| K970284 | ARTOS, DIPLOS SYSTEM | Turnkey Intergration USA, Inc. | 1997-04-21 | Traditional | PDF ↗ |
| K960643 | ADVANTAGE MAPF HIP FEMORAL COMPONENT | Biomet, Inc. | 1996-12-16 | Traditional | PDF ↗ |
| K963885 | ULTIMA FX FEMORAL HIP STEMS | Johnson & Johnson Professionals, Inc. | 1996-12-09 | Traditional | PDF ↗ |
| K962448 | PRIMALOC CEMENTED HIP SYSTEM | Ortho Development Corp. | 1996-09-19 | Traditional | PDF ↗ |
| K961793 | BI-LOC BIPOLAR CUP | Ortho Development Corp. | 1996-07-26 | Traditional | PDF ↗ |
| K945518 | P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT | Johnson & Johnson Professionals, Inc. | 1996-03-08 | Traditional | PDF ↗ |
| K953977 | PRIMALOC CEMENTLESS HIP SYSTEM | Ortho Development Corp. | 1996-01-26 | Traditional | PDF ↗ |
| K940743 | UHMWPE COMPONENTS-CHANGE IN PACKAGING | Depuy, Inc. | 1995-09-18 | Traditional | PDF ↗ |
| K953510 | HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS | Encore Orthopedics, Inc. | 1995-08-09 | Traditional | PDF ↗ |
| K945793 | P.F.C.(R) BIPOLAR HIP SYSTEM - 22MM BIPOLAR | Johnson & Johnson Professionals, Inc. | 1995-04-10 | Traditional | PDF ↗ |
| K941534 | MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEM | 3M Health Care, Ltd. | 1995-03-06 | Traditional | PDF ↗ |
| K944132 | P.F.C. TOTAL HIP SYSTEM | Johnson & Johnson Professionals, Inc. | 1995-01-06 | Traditional | PDF ↗ |
| K934159 | IOI COCR UNIPOLAR PROSTHESIS | Intermedics Orthopedics | 1994-07-21 | Traditional | PDF ↗ |
| K931655 | P.F.C. BIPOLAR HIP SYSTEM | Johnson & Johnson Orthopaedics, Inc. | 1994-06-09 | Traditional | PDF ↗ |
| K925153 | IT-7 FEMORAL COMPONENT, ANATOMIC HIP SYSTEM | Howmedica Corp. | 1994-03-01 | Traditional | PDF ↗ |
| K926387 | TECHMEDICA STANDARD CEMENTED HIP SYSTEM | Techmedica, Inc. | 1994-02-01 | Traditional | PDF ↗ |
| K925536 | HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM | Orthomet, Inc. | 1994-01-07 | Traditional | PDF ↗ |
| K925420 | TECHMEDICA STANDARD BIPOLAR SYSTEM | Techmedica, Inc. | 1993-09-28 | Traditional | PDF ↗ |
| K925897 | CORIN BIPOLAR PROSTHESIS | Corin Orthopedic Products | 1993-08-09 | Traditional | PDF ↗ |
| K922560 | CONSENSUS(TM) BIPOLAR SYSTEM | U.S. Medical Products, Inc. | 1992-09-11 | Traditional | PDF ↗ |
| K913632 | BATEMAN UPF-III BIPOLAR ENDOPROSTHESIS SYSTEM | Kirschner Medical Corp. | 1991-11-13 | Traditional | PDF ↗ |
| K905370 | EXACTECH BIPOLAR HIP PROSTHESIS | Exactech, Inc. | 1991-02-27 | Traditional | PDF ↗ |
| K904383 | ACUFIT TOTAL HIP | Acu Med, Inc. | 1990-12-20 | Traditional | PDF ↗ |
| K900051 | MOORE TYPE ENDO PROSTHESIS | Lima Intl. Corp. | 1990-10-03 | Traditional | PDF ↗ |
| K896257 | LEINBACH HIP PROSTHESIS | 3M Company | 1990-01-19 | Traditional | PDF ↗ |
| K895120 | BATEMAN UPF II HIP PROSTHESIS SYSTEM | 3M Company | 1990-01-11 | Traditional | PDF ↗ |
| K896266 | VS22 HIP PROSTHESIS | 3M Company | 1989-11-22 | Traditional | PDF ↗ |
| K893872 | P.F.C. HIP SYSTEM POROUS COATED FEMORAL COMPONENT | Johnson & Johnson Professionals, Inc. | 1989-09-11 | Traditional | PDF ↗ |
| K893959 | P.S.A. FEMORAL HIP PROSTHESIS | Protek, Inc. | 1989-07-25 | Traditional | PDF ↗ |
| K884658 | ZIMMER BEADED THREADED ACETABULAR CUP | Zimmer, Inc. | 1988-11-30 | Traditional | PDF ↗ |
| K881289 | CORIN BIPOLAR PROSTHESIS | Orthopedic Systems, Inc. | 1988-06-29 | Traditional | PDF ↗ |
| K873815 | IOI BIPOLAR PROSTHESIS | Intermedics Orthopedics | 1987-10-28 | Traditional | PDF ↗ |
| K873514 | JOHNSON & JOHNSON BIPOLAR ENDOPROTHESIS | Johnson & Johnson Professionals, Inc. | 1987-09-24 | Traditional | PDF ↗ |
| K872019 | BI-ARTICULAR II HIP DEVICE | Zimmer, Inc. | 1987-07-21 | Traditional | PDF ↗ |
| K862460 | FEMORAL HEMI-HIP PROSTHESIS | Orthopaedic Device Corp. | 1986-10-06 | Traditional | PDF ↗ |
| K862057 | KIRSCHNER UNIVERSAL BIPOLAR ENDOPROSTHETIC HEAD | Kirschner Medical Corp. | 1986-07-11 | Traditional | PDF ↗ |
| K861566 | SLR BIPOLAR HIP ENDOPROSTHESIS | Dow Corning Wright | 1986-05-12 | Traditional | PDF ↗ |
| K861105 | HOWMEDICA BIPOLAR PROSTHESIS | Howmedica Corp. | 1986-04-14 | Traditional | PDF ↗ |
| K855231 | HOWMEDICA BIPOLAR PROSTHESIS | Howmedica Corp. | 1986-02-27 | Traditional | PDF ↗ |
| K853795 | KIRSCHNER BIPOLAR ENDOPROSTHETIC HEAD | Kirschner Medical Corp. | 1985-11-22 | Traditional | PDF ↗ |
| K842344 | HASTINGS BIPOLAR ENDOPROSTHESIS | Johnson & Johnson Professionals, Inc. | 1984-09-12 | Traditional | PDF ↗ |
| K833404 | BDH BIPOLAR FEMORAL COMPONENT A3 | Carbomedics, Inc. | 1984-03-02 | Traditional | PDF ↗ |
| K833991 | BIPOLAR HIP DEVICE | Zimmer | 1984-01-30 | Traditional | PDF ↗ |
| K833175 | BIOMET BIPOLAR PROSTHESIS | Biomet, Inc. | 1983-12-22 | Traditional | PDF ↗ |
| K823726 | SPECTRON CONVERSION ENDOPROSTHESIS CUP | Richard'S Medical Equip., Inc. | 1983-03-09 | Traditional | PDF ↗ |
| K823482 | 101 UNIVERSAL ENDOPROSTHESIS | Intermedics Orthopedics | 1983-02-07 | Traditional | PDF ↗ |
| K812672 | SELF-CENTERING HIP | Depuy, Inc. | 1981-10-08 | Traditional | PDF ↗ |
| K810062 | BI-CENTRIC BI-POLAR ENDOPROSTHESIS | Howmedica Corp. | 1981-01-26 | Traditional | PDF ↗ |
| K791823 | 3M UPF PROXIMAL FEMUR REPLACEMENT SYSTEM | 3M Company | 1979-10-30 | Traditional | PDF ↗ |
| K781735 | ENDOPROSTHESIS SYSTEM, VARIO-HEAD | Waldemar Link GmbH & Co. KG | 1978-10-24 | Traditional | PDF ↗ |
Product code KWY · Class II · Orthopedic. Data: openFDA.