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 |
|---|---|---|---|
| Dec 16, 1998 | K980926 | DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION Howmedica Corp. | JDI |
| Dec 11, 1998 | K980626 | DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION Howmedica Corp. | JDI |
| Dec 4, 1998 | K983226 | OSTEONICS X CEMENTED HIP STEM SERIES Osteonics Corp. | JDI |
| Dec 3, 1998 | K983128 | IMPLEX HEDROCEL REPLACEMENT CUP INSERT MODEL NUMBERS 02-246-XXYYY, 02-247-XXYYY, 02-248-XXYYY Implex Corp. | JDI |
| Dec 2, 1998 | K983710 | 150MM COCR BIMETRIC HEAD/NECK REPLACEMENT HIP STEM- COLOR BUFF FINISH Biomet, Inc. | JDI |
| Nov 25, 1998 | K983136 | DEPUY LUSTER STEM DePuy Orthopaedics, Inc. | JDI |
| Nov 20, 1998 | K982963 | POLYMER THREADED ANCHOR / SUTURE COMBINATION Orthopaedic Biosystems, Ltd. | JDI |
| Oct 5, 1998 | K982918 | DEPUY C-STEM SYSTEM DePuy Orthopaedics, Inc. | JDI |
| Oct 2, 1998 | K982670 | CONTEMPORARY ACETABULAR COMPONENT Howmedica Corp. | JDI |
| Oct 2, 1998 | K982598 | OTI FEMORAL LOCK TOTAL HIP SYSTEM Osteoimplant Technology, Inc. | JDI |
| Sep 22, 1998 | K974685 | OSTEONICS POLYETHYLENE ACETABULAR COMPONENTS Osteonics Corp. | JDI |
| Aug 10, 1998 | K981855 | PRINCE MEDICAL CEMENT PLUG Prince Medical, Inc. | JDI |
| Jun 26, 1998 | K980813 | RELIANCE LONG STEM FEMORAL COMPONENTS Howmedica, Inc. | JDI |
| Jun 2, 1998 | K980843 | EXETER INTRAMEDULLARY BONE PLUG Howmedica, Inc. | JDI |
| May 20, 1998 | K980794 | DUAL LOCK HIP STEM Depuy, Inc. | JDI |
| Apr 14, 1998 | K980513 | ARTICUL/EZE FEMORAL HEADS DePuy Orthopaedics, Inc. | JDI |
| Apr 14, 1998 | K980486 | IMPLEX HEP ACETABULAR REVISION CUP, CEMENTED OR CEMENTLESS MODEL A-240 SYSTEM Implex Corp. | JDI |
| Apr 3, 1998 | K980286 | ULTIMA ACETABULAR ROOF REINFORCEMENT RING Johnson & Johnson Professionals, Inc. | JDI |
| Mar 4, 1998 | K974558 | SALVAGE/ONOCOLOGY HIP AND TOTAL FEMUR SYSTEM Biomet, Inc. | JDI |
| Jan 12, 1998 | K972791 | ENCORE LINEAR HIP Encore Orthopedics, Inc. | JDI |
| Jan 2, 1998 | K973809 | FOUNDATION FRACTURE STEM Encore Orthopedics, Inc. | JDI |
| Dec 23, 1997 | K974054 | DISTAL CENTRALIZER, EXETER II HIP SYSTEM Howmedica, Inc. | JDI |
| Dec 9, 1997 | K973453 | TORNIER CEMENT RESTRICTOR Tornier | JDI |
| Dec 4, 1997 | K971681 | SMC FEMORAL HIP COMPONENT Signal Medical Corp. | JDI |
| Nov 24, 1997 | K973296 | EXTEND HIP STEM Wrightmedicaltechnologyinc | JDI |
| Nov 10, 1997 | K972995 | THE C-FIT & DC-FIT ACETABULAR CUP SYSTEM Corin USA | JDI |
| Nov 4, 1997 | K972961 | STELKAST BIPOLAR SYSTEM Stelkast Company | JDI |
| Nov 3, 1997 | K972928 | KERBOULL CROSS Howmedica, Inc. | JDI |
| Oct 16, 1997 | K972792 | DURATION STABILIZED UHMWPE ACETABULAR COMPONENTS Howmedica Corp. | JDI |
| Oct 9, 1997 | K972641 | DUAL OFFSET PERFECTA IMC HIP STEM Wrightmedicaltechnologyinc | JDI |
| Sep 25, 1997 | K972460 | OSTEONICS OMNIFIT-C CEMENTED HIP STEM (LINE EXTENSION) Osteonics Corp. | JDI |
| Sep 11, 1997 | K972435 | ULTIMA AND ULTIMA LX CEMENTED FEMORAL STEM Johnson & Johnson Professionals, Inc. | JDI |
| Aug 7, 1997 | K971890 | RECOVERY PROTRUSIO CAGE Biomet, Inc. | JDI |
| Aug 6, 1997 | K971705 | IMPLEX HEP ACETABULAR CUP SYSTEM, CEMENTED Implex Corp. | JDI |
| Jul 18, 1997 | K971581 | HEMISPHERE CEMENTED CUP Ortho Development Corp. | JDI |
| Jun 11, 1997 | K963612 | DURATION STABILIZED UHMWPE Howmedica Corp. | JDI |
| Apr 24, 1997 | K970697 | OSTEONICS NORMALIZED AD ACETABULAR COMPONENT SYSTEM Osteonics Corp. | JDI |
| Apr 14, 1997 | K970194 | PROFORM CEMENTED TITANIUM REVISION FEMORAL COMPONENT Stelkast Company | JDI |
| Mar 25, 1997 | K965019 | THE C-FIT FEMORAL HIP SYSTEM Corin USA | JDI |
| Mar 21, 1997 | K964003 | METAGEN ALL POLY ACETABULAR CUP SYSTEM Metagen, LLC | JDI |
| Feb 28, 1997 | K970351 | GLOBAL TAPER SPECTRON HIP STEMS Smith & Nephew, Inc., Orthopaedic Div. | JDI |
| Feb 19, 1997 | K964795 | CEMENTED CALCAR REPLACEMENT FEMORAL STEM Johnson & Johnson Professionals, Inc. | JDI |
| Feb 6, 1997 | K964655 | UHMWPE HIP AND KNEE COMPONENTS - PACKAGING CHANGE Howmedica Corp. | JDI |
| Feb 3, 1997 | K963671 | OSTEONICS FLANGED POLYETHYLENE ACETABULAR CUP Osteonics Corp. | JDI |
| Feb 3, 1997 | K962468 | HEDROCEL ACETABULAR RESTRICTOR Implex Corp. | JDI |
| Jan 16, 1997 | K964350 | MODULA OPTIONS FOR SEVERE BONE LOSS AND TRAUMA Intermedics Orthopedics | JDI |
| Jan 9, 1997 | K963109 | HERITAGE HIP SYSTEM Zimmer, Inc. | JDI |
| Jan 8, 1997 | K964218 | PERFECTA PLASMA SPRAY HIP STEM Wrightmedicaltechnologyinc | JDI |
| Dec 27, 1996 | K964262 | EXACTECH TOTAL HIP SYSTME: 22MM FEMORAL HEAD Exactech, Inc. | JDI |
| Nov 27, 1996 | K963486 | REVISION HIP SYSTEM Smith & Nephew Richards, Inc. | JDI |
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