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 |
|---|---|---|---|
| Jun 15, 1995 | K950418 | ALPHA POROUS COATED FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL) Wrightmedicaltechnologyinc | JDI |
| May 31, 1995 | K951084 | S-ROM OPC (ONE-PIECE CEMENTED) II FEMORAL HIP PROSTHESIS Joint Medical Products Corp. | JDI |
| May 30, 1995 | K945574 | OSTEONICS(R) CCR HIP STEM SERIES Osteonics Corp. | JDI |
| May 17, 1995 | K950312 | ALPHA SYSTEM Zimmer, Inc. | JDI |
| May 17, 1995 | K943696 | ALL POLYETHYLENE CEMENTED ACETABULAR CUP Depuy, Inc. | JDI |
| May 2, 1995 | K950761 | INDEX ACETABULAT COMPONENT Biomet, Inc. | JDI |
| May 2, 1995 | K945115 | MALLORY-HEAD MODULAR CALCAR REPACEMENT COMPONENTS Biomet, Inc. | JDI |
| Apr 26, 1995 | K944792 | ZIMMER MONOBLOC HIP PROSTHESIS WITH POLY (METHYL METHACRYLATE) Zimmer, Inc. | JDI |
| Apr 7, 1995 | K940328 | PRIME CEMENTED HIP SYSTEM Orthopaedic Innovations, Inc. | JDI |
| Apr 5, 1995 | K946371 | PROVIDENT HP SYSTEM Stelkast Company | JDI |
| Mar 30, 1995 | K935449 | FOUNDATION NON-POROUS STEM Encore Orthopedics, Inc. | JDI |
| Jan 19, 1995 | K940307 | HOWMEDICA STRAIGHT STEM FEMORAL COMPONENT Howmedica, Inc. | JDI |
| Jan 9, 1995 | K942537 | PARAMOUNT CEMENTED HIP STEM PROTHESIS Depuy, Inc. | JDI |
| Dec 19, 1994 | K943549 | RESTORATION ACETABULAR CUP Osteonics Corp. | JDI |
| Nov 30, 1994 | K930771 | PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM Orthomet, Inc. | JDI |
| Nov 10, 1994 | K942370 | DEPUY CEMENTED HIP PROSTHESIS Depuy, Inc. | JDI |
| Oct 26, 1994 | K936127 | HOWMEDICA PREMIUM FEMORAL COMPONENT Howmedica, Inc. | JDI |
| Oct 20, 1994 | K936126 | HOWMEDICS DRG FEMORAL COMPONENT Howmedica, Inc. | JDI |
| Oct 14, 1994 | K943302 | AML TRI-LOCK REPLACEMENT LINER SYSTEM Depuy, Inc. | JDI |
| Oct 14, 1994 | K942966 | AML TRILOCK REPLACEMENT LINER SYSTEM Depuy, Inc. | JDI |
| Oct 6, 1994 | K941617 | APR ACETABULAR INSERT Intermedics Orthopedics | JDI |
| Oct 5, 1994 | K942406 | OPTION SHELL Intermedics Orthopedics | JDI |
| Sep 28, 1994 | K942611 | FOUNDATION ALL POLY CUP Encore Orthopedics, Inc. | JDI |
| Sep 20, 1994 | K941486 | INTEGRITY TOTAL HIP SYSTEM, NON-POROUS Kirschner Medical Corp. | JDI |
| Sep 1, 1994 | K930275 | PRECISION OSTEOLOCK ACETABULAR COMPONENT Howmedica Corp. | JDI |
| Jul 18, 1994 | K935951 | KIRSCHNER C-2 OSTEOCAP TOTAL HIP SYSTEM Kirschner Medical Corp. | JDI |
| Jul 13, 1994 | K935206 | KIRSCHNER INTEGRITY ACETABULAR CUP MODIFICATION Kirschner Medical Corp. | JDI |
| Jun 15, 1994 | K936214 | CS-PLUS STEM Encore Orthopedics, Inc. | JDI |
| Jun 14, 1994 | K936132 | EXETER ALL PLASTIC ACETABULAR COMPONENT Howmedica, Inc. | JDI |
| Jun 8, 1994 | K932481 | SL-PLUS AND SLR-PLUS Encore Orthopedics, Inc. | JDI |
| Jun 7, 1994 | K933281 | S.O.S. PROXIMAL FEMUR Wrightmedicaltechnologyinc | JDI |
| Jun 3, 1994 | K936043 | FOUNDATION POROUS ACETABULAR COMPONENT Encore Orthopedics, Inc. | JDI |
| May 3, 1994 | K934169 | FOUNDATION ALL POLY CUP Encore Orthopedics, Inc. | JDI |
| Mar 10, 1994 | K932574 | RMHS POROUS DISTAL SLEEVE Smith & Nephew Richards, Inc. | JDI |
| Mar 9, 1994 | K933561 | OSTEONICS OMNIFIT FORGED HIP STEM SERIES Osteonics Corp. | JDI |
| Mar 7, 1994 | K935012 | BIOMETRIC TOTAL HIP SYSTEM Osteo-Technology Intl., Inc. | JDI |
| Mar 3, 1994 | K930187 | OSTEONICS(R) ARC DEPOSITIONED FEMORAL COMPONENTS Osteonics Corp. | JDI |
| Mar 1, 1994 | K933875 | PREMISE CEMENTED FEMORAL STEM, ADDITION STYLE Howmedica Corp. | JDI |
| Feb 23, 1994 | K903630 | PRECISION OSTEOFLEX FEMORAL COMPONENT Howmedica Corp. | JDI |
| Feb 22, 1994 | K930460 | HOWMEDICA REVISION HIP SYSTEM Howmedica Corp. | JDI |
| Feb 22, 1994 | K930223 | HOWMEDICA ACETABULAR SHELL Howmedica Corp. | JDI |
| Feb 22, 1994 | K926229 | APC FEMORAL COMPONENT Howmedica Corp. | JDI |
| Jan 7, 1994 | K923243 | PERFECTA TOTAL HIP SYSTEM Orthomet, Inc. | JDI |
| Nov 17, 1993 | K930812 | APR FEMORAL HIP COMPONENT Intermedics Orthopedics | JDI |
| Sep 23, 1993 | K925866 | CENATOR TOTAL HIP SYSTEM Corin Orthopedic Products | JDI |
| Sep 21, 1993 | K930108 | RMHS POROUS DISTAL SLEEVE Smith & Nephew Richards, Inc. | JDI |
| Jun 15, 1993 | K925201 | EXACTECH FEMORAL STEM Exactech, Inc. | JDI |
| May 26, 1993 | K926323 | H-110 ACETABULAR CUP SYSTEM Implex Corp. | JDI |
| May 19, 1993 | K905262 | BUECHEL-PAPPAS EXTENDED COLLAR FEMORAL STEM PROSTH Endotec, Inc. | JDI |
| May 12, 1993 | K925348 | IMPLEX H-110 AND H-120 CEMENTED HIP STEM SYSTEM Implex Corp. | JDI |
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