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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 21, 1991 | K912426 | UHMWP ACETABULAR COMPONENT Howmedica Corp. | JDI |
| Jul 26, 1991 | K911890 | OSTEONICS(R) PRT HIP STEM SERIES Osteonics Corp. | JDI |
| Jul 26, 1991 | K904737 | GROSS HIP FEMORAL COMPONENT Johnson & Johnson Orthopaedics, Inc. | JDI |
| Jul 16, 1991 | K911718 | M.A.R.A. (MODULAR ACETABULAR RECONSTRUCTION SYST) Biomet, Inc. | JDI |
| Jul 15, 1991 | K911685 | RANAWAT/BURSTEIN POROUS TOTAL HIP FEMORAL COMP Biomet, Inc. | JDI |
| Jul 1, 1991 | K910093 | FUTURA FEMORAL HIP STEM O'Tec Corp. | JDI |
| Jun 27, 1991 | K911684 | BIOMET COBALT-CHROME FEMORAL COMPONENTS Biomet, Inc. | JDI |
| Jun 17, 1991 | K911052 | NEXUS(TM) FEMORAL HIP STEM Dow Corning Wright | JDI |
| Jun 17, 1991 | K905298 | TITAN TOTAL HIP DEVICE Dr. Jean-Marc Guichet | JDI |
| Jun 14, 1991 | K910836 | LIMA COLLARED CL STEM Lima Intl. Corp. | JDI |
| Jun 13, 1991 | K910352 | BIOPRO METAL BACKED CEMENTED ACETABULAR CUP Biopro, Inc. | JDI |
| May 23, 1991 | K910869 | HOWMEDICA(R) CEMETED FEMORAL COMPONENT Howmedica Corp. | JDI |
| May 21, 1991 | K905258 | S-ROM OBLONG ACETABULAR CUP Joint Medical Products Corp. | JDI |
| May 13, 1991 | K910662 | PS OMNIFIT NORMALIZED HIP STEM SERIES Osteonics Corp. | JDI |
| Apr 5, 1991 | K910922 | OSTEONICS CDH HIP STEM Osteonics Corp. | JDI |
| Mar 26, 1991 | K910988 | OSTEONICS ION IMPLANTED FEMORAL BEARING SERIES Osteonics Corp. | JDI |
| Mar 1, 1991 | K905408 | NEXUS ACETABULAR CUP Dow Corning Wright | JDI |
| Jan 28, 1991 | K905275 | OSTEONICS(R) MPSS HIP STEM SERIES Osteonics Corp. | JDI |
| Jan 4, 1991 | K905406 | OSTEONICS HIP REVISION WEDGES Osteonics Corp. | JDI |
| Jan 4, 1991 | K905158 | OSTEONICS(R) 6011 HIP STEM SERIES Osteonics Corp. | JDI |
| Jan 4, 1991 | K904207 | BIOPRO TRINITY ACETABULAR CUP Biopro, Inc. | JDI |
| Jan 4, 1991 | K903938 | C FIT CUP Orthopedic Systems, Inc. | JDI |
| Jan 1, 1991 | K896851 | PGR HIP STEM (ENDOPROSTHESIS) FOR LARGE BONE RESEC Lima Intl. Corp. | JDI |
| Dec 5, 1990 | K904919 | PROXIMAL FEMUR REPLACEMENT STEM Depuy, Inc. | JDI |
| Dec 5, 1990 | K904844 | PRECISION HIP STEM WITH ADDITIONAL STEM SIZES Howmedica Corp. | JDI |
| Nov 26, 1990 | K903957 | VSP HIP STEM Turnkey Intergration USA, Inc. | JDI |
| Nov 9, 1990 | K903635 | PERFECTA TOTAL HIP SYSTEM Orthomet, Inc. | JDI |
| Oct 30, 1990 | K903636 | OSTEONICS DRM ACETABULAR COMPONENT Osteonics Corp. | JDI |
| Oct 23, 1990 | K903116 | RM ISOELASTIC BEVELLED ACETABULAR CUP Robert Mathys Co. | JDI |
| Oct 22, 1990 | K903362 | OSTEOLOCK(TM) ACETABULAR CUP Howmedica Corp. | JDI |
| Oct 17, 1990 | K904351 | FOCUS COBALT CHROMIUM TOTAL HIP Depuy, Inc. | JDI |
| Oct 10, 1990 | K903234 | F-19 TOTAL HIP PROSTHESIS Med-Tek Corp. | JDI |
| Oct 3, 1990 | K902961 | DIMENSION-II TOTAL HIP SYSTEM Kirschner Medical Corp. | JDI |
| Sep 14, 1990 | K900261 | ACSYS PREFIX ACETABULAR CUP PROSTHESIS 3M Company | JDI |
| Sep 11, 1990 | K902621 | SL-SELF LOCKING TOTAL HIP-FEMORAL COMPONENT Lima Intl. Corp. | JDI |
| Aug 31, 1990 | K901451 | F-20 CEMENTED METAL-BACKED ACETABULAR CUP Med-Tek Corp. | JDI |
| Aug 29, 1990 | K902436 | HG MULTILOCK HIP PROSTHESIS W/TINIDIUM SURFACE Zimmer, Inc. | JDI |
| Aug 24, 1990 | K902396 | MODIFIED DEPUY ACETABULAR CUP SYSTEM Depuy, Inc. | JDI |
| Aug 24, 1990 | K902395 | MODIFIED AML + ACETABULAR CUP SYSTEM Depuy, Inc. | JDI |
| Aug 9, 1990 | K902727 | LSF CEMENTED FEMORAL HIP Implant Technology, Inc. | JDI |
| Aug 9, 1990 | K902279 | KM-5 METAL BACKED ACETABULAR CUP Kirschner Medical Corp. | JDI |
| Jul 30, 1990 | K903243 | MULLER-TYPE FEMORAL COMPONENT Onyx Medical Corp. | JDI |
| Jul 30, 1990 | K903242 | ACETABULAR CUP Onyx Medical Corp. | JDI |
| Jun 26, 1990 | K902137 | P.F.C. HIP SYSTEM NON-POROUS ACETABULAR COMPONENT Johnson & Johnson Orthopaedics, Inc. | JDI |
| Jun 12, 1990 | K901480 | F-20 TOTAL HIP PROSTHESIS Med-Tek Corp. | JDI |
| May 22, 1990 | K901460 | LSF(TM) TOTAL HIP SYSTEM Implant Technology, Inc. | JDI |
| May 22, 1990 | K901328 | DOMED AND FINNED ACETABULAR COMPONENT Orthomet, Inc. | JDI |
| May 18, 1990 | K901364 | HGP II TOTAL HIP FEMERAL STEM Zimmer, Inc. | JDI |
| May 7, 1990 | K901087 | MODIFIED PROFILE II ACETABULAR CUP PROSTHESIS Depuy, Inc. | JDI |
| May 4, 1990 | K900832 | MODIFIED DEPUY ACETABULAR CUP SYSTEM* HIP ACETA. Depuy, Inc. | JDI |
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