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 |
|---|---|---|---|
| May 2, 1990 | K901297 | EXACTECH POROUS COAT TOTAL HIP PROST FEM STEM COMP Exactech, Inc. | JDI |
| Apr 18, 1990 | K900438 | MC2P ACETABULAR COMPONENT Osteonics Corp. | JDI |
| Apr 18, 1990 | K900257 | MULLER TYPE ACETABULAR CUP Lima Intl. Corp. | JDI |
| Mar 26, 1990 | K901240 | ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED Med-Tek Corp. | JDI |
| Mar 21, 1990 | K900836 | OSTEONICS ECSI HIP STEM SERIES Osteonics Corp. | JDI |
| Mar 12, 1990 | K900891 | MODIFIED AML + ACETABULAR CUP PROSTHESIS Depuy, Inc. | JDI |
| Jan 31, 1990 | K895036 | TITANIUM MODULAR MODULAR COLLARLESS HIP Depuy, Inc. | JDI |
| Jan 31, 1990 | K895035 | TITANIUM MODULAR COLLARED HIP PROSTHESIS Depuy, Inc. | JDI |
| Jan 29, 1990 | K896325 | QUANTUM HIP STEM Depuy, Inc. | JDI |
| Dec 14, 1989 | K895636 | DIMENSION REVISION TOTAL HIP SYSTEM Kirschner Medical Corp. | JDI |
| Dec 8, 1989 | K884890 | LORD L.F.R. TOTAL HIP SYSTEM Howmedica Corp. | JDI |
| Nov 6, 1989 | K893821 | ACETABULAR SHELLS & LINERS FOR ATH TOTAL HIP SYST. Kinamed, Inc. | JDI |
| Oct 13, 1989 | K890498 | FREEMAN MODULAR HIP STEM RIDGED VERSION Orthopedic Systems, Inc. | JDI |
| Sep 27, 1989 | K894298 | MODIFIED GEMINI ACETABULAR CUP Depuy, Inc. | JDI |
| Sep 14, 1989 | K894149 | MOD. FEMORAL COM. & CLUSTER PATTER OUTER SHELL Howmedica Corp. | JDI |
| Sep 5, 1989 | K894148 | MOD. FEMORAL COMP. NON-BEADED & BASIC ACE. SHELL Howmedica Corp. | JDI |
| Aug 3, 1989 | K894249 | UNIVERSAL CEMENTED CUP Orthopedic Systems, Inc. | JDI |
| Jun 22, 1989 | K885192 | APR COLLARED REVISION FEMORAL COMPONENT Intermedics Orthopedics | JDI |
| Jun 7, 1989 | K891454 | EXETER II TOTAL HIP SYSTEM Howmedica Corp. | JDI |
| May 10, 1989 | K890742 | INTRAFORM TOTAL HIP SYSTEM Orthomet, Inc. | JDI |
| Apr 7, 1989 | K884027 | PERFECTA II/NON-COATED TOTAL HIP SYSTEM Orthomet, Inc. | JDI |
| Mar 15, 1989 | K885338 | AML BOWED FEMORAL HIP Depuy, Inc. | JDI |
| Mar 13, 1989 | K890649 | OMNIFIT UHMWPE ACETABULAR SHELL CEMENT SPACE SYST. Osteonics Corp. | JDI |
| Feb 8, 1989 | K890054 | M.E.M. ACETABULAR CUP W/SULMESH FOR CEMENT APPLI. Protek, Inc. | JDI |
| Dec 29, 1988 | K884888 | MODIFIED NEW JERSEY ACETABULAR COMP. & BONE SCREWS Protek, Inc. | JDI |
| Dec 28, 1988 | K883618 | PERFECTA II TOTAL HIP SYSTEM Orthomet, Inc. | JDI |
| Dec 9, 1988 | K884432 | MODIFIED LSF TOTAL HIP SYSTEM Implant Technology, Inc. | JDI |
| Nov 30, 1988 | K883941 | PROFORMA HIP SYSTEM Orthomet, Inc. | JDI |
| Nov 17, 1988 | K884457 | MODULAR COLLARED HJD TOTAL HIP SYSTEM Richards Medical Co., Inc. | JDI |
| Nov 16, 1988 | K883724 | GEMINI FEMORAL HIP PROSTHESIS Depuy, Inc. | JDI |
| Oct 14, 1988 | K882869 | TOWNLEY COX COMB ACETABULAR COMPONENT Biopro, Inc. | JDI |
| Oct 11, 1988 | K883460 | FOCUS TOTAL HIP SYSTEM Depuy, Inc. | JDI |
| Aug 29, 1988 | K882146 | BIOPRO PC FEMORAL HIP COMPONENT Biopro, Inc. | JDI |
| Aug 8, 1988 | K882812 | OMNIFIT ACETABULAR SHELL CEMENT SPACER SYSTEM Osteonics Corp. | JDI |
| Jun 29, 1988 | K880435 | PROFORMA/PS TOTAL HIP SYSTEM Orthomet, Inc. | JDI |
| Jun 22, 1988 | K881769 | HJD CALCAR REPLACEMENT PROSTHESIS Richards Medical Co., Inc. | JDI |
| May 6, 1988 | K880269 | LCS FEMORAL HIP PROSTHESIS Depuy, Inc. | JDI |
| Apr 29, 1988 | K881117 | RESUBMITTING OF HJD TOTAL HIP SYSTEM Richards Medical Co., Inc. | JDI |
| Apr 8, 1988 | K871867 | ELITE MODULAR HIP SYSTEM Thackray USA | JDI |
| Apr 5, 1988 | K880390 | INTRAFORM TOTAL HIP SYSTEM Orthomet, Inc. | JDI |
| Mar 21, 1988 | K881128 | TITANIUM FEMORAL HIP Depuy, Inc. | JDI |
| Mar 15, 1988 | K880461 | PERFECTA TOTAL HIP SYSTEM Orthomet, Inc. | JDI |
| Feb 18, 1988 | K880004 | TOWNLEY COX COMB ACETABULAR CUP Orthomet, Inc. | JDI |
| Feb 18, 1988 | K871852 | COXA ACETABULAR CUP Thackray USA | JDI |
| Feb 17, 1988 | K874619 | SPECTRON EF ACETABULAR COMPONENT Richards Medical Co., Inc. | JDI |
| Jan 29, 1988 | K874616 | MOORE HIP PROSTHESIS FENESTRATED STEM Orthopedic Systems, Inc. | JDI |
| Jan 29, 1988 | K874599 | MOORE HIP PROSTHESIS SOLID STEM Orthopedic Systems, Inc. | JDI |
| Jan 27, 1988 | K874093 | SLS-88 TOTAL HIP SYSTEM, ACETABULAR CUP Protek, Inc. | JDI |
| Dec 31, 1987 | K873626 | FREEMAN TOTAL HIP SYSTEM TITANIUM MODULAR SYSTEM Orthopedic Systems, Inc. | JDI |
| Dec 7, 1987 | K873632 | HI-NEK TOTAL HIP Orthopedic Systems, Inc. | JDI |
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