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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 16, 1996 | K960643 | ADVANTAGE MAPF HIP FEMORAL COMPONENT Biomet, Inc. | KWY |
| Dec 9, 1996 | K963885 | ULTIMA FX FEMORAL HIP STEMS Johnson & Johnson Professionals, Inc. | KWY |
| Sep 19, 1996 | K962448 | PRIMALOC CEMENTED HIP SYSTEM Ortho Development Corp. | KWY |
| Jul 26, 1996 | K961793 | BI-LOC BIPOLAR CUP Ortho Development Corp. | KWY |
| Mar 8, 1996 | K945518 | P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT Johnson & Johnson Professionals, Inc. | KWY |
| Jan 26, 1996 | K953977 | PRIMALOC CEMENTLESS HIP SYSTEM Ortho Development Corp. | KWY |
| Sep 18, 1995 | K940743 | UHMWPE COMPONENTS-CHANGE IN PACKAGING Depuy, Inc. | KWY |
| Aug 9, 1995 | K953510 | HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS Encore Orthopedics, Inc. | KWY |
| Apr 10, 1995 | K945793 | P.F.C.(R) BIPOLAR HIP SYSTEM - 22MM BIPOLAR Johnson & Johnson Professionals, Inc. | KWY |
| Mar 6, 1995 | K941534 | MODULAR VS-22 CEMENTED FEMORAL HIP SYSTEM 3M Health Care, Ltd. | KWY |
| Jan 6, 1995 | K944132 | P.F.C. TOTAL HIP SYSTEM Johnson & Johnson Professionals, Inc., GB | KWY |
| Jul 21, 1994 | K934159 | IOI COCR UNIPOLAR PROSTHESIS Intermedics Orthopedics | KWY |
| Jun 9, 1994 | K931655 | P.F.C. BIPOLAR HIP SYSTEM Johnson & Johnson Orthopaedics, Inc. | KWY |
| Mar 1, 1994 | K925153 | IT-7 FEMORAL COMPONENT, ANATOMIC HIP SYSTEM Howmedica Corp. | KWY |
| Feb 1, 1994 | K926387 | TECHMEDICA STANDARD CEMENTED HIP SYSTEM Techmedica, Inc. | KWY |
| Jan 7, 1994 | K925536 | HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM Orthomet, Inc. | KWY |
| Sep 28, 1993 | K925420 | TECHMEDICA STANDARD BIPOLAR SYSTEM Techmedica, Inc. | KWY |
| Aug 9, 1993 | K925897 | CORIN BIPOLAR PROSTHESIS Corin Orthopedic Products | KWY |
| Sep 11, 1992 | K922560 | CONSENSUS(TM) BIPOLAR SYSTEM U.S. Medical Products, Inc. | KWY |
| Nov 13, 1991 | K913632 | BATEMAN UPF-III BIPOLAR ENDOPROSTHESIS SYSTEM Kirschner Medical Corp. | KWY |
| Feb 27, 1991 | K905370 | EXACTECH BIPOLAR HIP PROSTHESIS Exactech, Inc. | KWY |
| Dec 20, 1990 | K904383 | ACUFIT TOTAL HIP Acu Med, Inc. | KWY |
| Oct 3, 1990 | K900051 | MOORE TYPE ENDO PROSTHESIS Lima Intl. Corp. | KWY |
| Jan 19, 1990 | K896257 | LEINBACH HIP PROSTHESIS 3M Company | KWY |
| Jan 11, 1990 | K895120 | BATEMAN UPF II HIP PROSTHESIS SYSTEM 3M Company | KWY |
| Nov 22, 1989 | K896266 | VS22 HIP PROSTHESIS 3M Company | KWY |
| Sep 11, 1989 | K893872 | P.F.C. HIP SYSTEM POROUS COATED FEMORAL COMPONENT Johnson & Johnson Professionals, Inc. | KWY |
| Jul 25, 1989 | K893959 | P.S.A. FEMORAL HIP PROSTHESIS Protek, Inc. | KWY |
| Nov 30, 1988 | K884658 | ZIMMER BEADED THREADED ACETABULAR CUP Zimmer, Inc. | KWY |
| Jun 29, 1988 | K881289 | CORIN BIPOLAR PROSTHESIS Orthopedic Systems, Inc. | KWY |
| Oct 28, 1987 | K873815 | IOI BIPOLAR PROSTHESIS Intermedics Orthopedics | KWY |
| Sep 24, 1987 | K873514 | JOHNSON & JOHNSON BIPOLAR ENDOPROTHESIS Johnson & Johnson Professionals, Inc. | KWY |
| Jul 21, 1987 | K872019 | BI-ARTICULAR II HIP DEVICE Zimmer, Inc. | KWY |
| Oct 6, 1986 | K862460 | FEMORAL HEMI-HIP PROSTHESIS Orthopaedic Device Corp. | KWY |
| Jul 11, 1986 | K862057 | KIRSCHNER UNIVERSAL BIPOLAR ENDOPROSTHETIC HEAD Kirschner Medical Corp. | KWY |
| May 12, 1986 | K861566 | SLR BIPOLAR HIP ENDOPROSTHESIS Dow Corning Wright | KWY |
| Apr 14, 1986 | K861105 | HOWMEDICA BIPOLAR PROSTHESIS Howmedica Corp. | KWY |
| Feb 27, 1986 | K855231 | HOWMEDICA BIPOLAR PROSTHESIS Howmedica Corp. | KWY |
| Nov 22, 1985 | K853795 | KIRSCHNER BIPOLAR ENDOPROSTHETIC HEAD Kirschner Medical Corp. | KWY |
| Sep 12, 1984 | K842344 | HASTINGS BIPOLAR ENDOPROSTHESIS Johnson & Johnson Professionals, Inc. | KWY |
| Mar 2, 1984 | K833404 | BDH BIPOLAR FEMORAL COMPONENT A3 Carbomedics, Inc. | KWY |
| Jan 30, 1984 | K833991 | BIPOLAR HIP DEVICE Zimmer | KWY |
| Dec 22, 1983 | K833175 | BIOMET BIPOLAR PROSTHESIS Biomet, Inc. | KWY |
| Mar 9, 1983 | K823726 | SPECTRON CONVERSION ENDOPROSTHESIS CUP Richard'S Medical Equip., Inc. | KWY |
| Feb 7, 1983 | K823482 | 101 UNIVERSAL ENDOPROSTHESIS Intermedics Orthopedics | KWY |
| Oct 8, 1981 | K812672 | SELF-CENTERING HIP Depuy, Inc. | KWY |
| Jan 26, 1981 | K810062 | BI-CENTRIC BI-POLAR ENDOPROSTHESIS Howmedica Corp. | KWY |
| Oct 30, 1979 | K791823 | 3M UPF PROXIMAL FEMUR REPLACEMENT SYSTEM 3M Company | KWY |
| Oct 24, 1978 | K781735 | ENDOPROSTHESIS SYSTEM, VARIO-HEAD Waldemar Link GmbH & Co. KG | KWY |
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