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 |
|---|---|---|---|
| Nov 14, 1996 | K963313 | EXACTECH ALL POLY ACETABULAR CUP Exactech, Inc. | JDI |
| Oct 17, 1996 | K963206 | S-ROM HIP SYSTEM - LOCKING PLUG Johnson & Johnson Professionals, Inc. | JDI |
| Oct 10, 1996 | K955137 | IM C-MENT ACETABULAR CAP Implant Ideas, LLC | JDI |
| Oct 3, 1996 | K960425 | BUECHEL-PAPPAS POLYETHLENE ACETABULAR COMPONENT(01-42-YYXX & 01-43-YYXX Endotec, Inc. | JDI |
| Oct 1, 1996 | K961304 | AURA HIP SYSTEM CEMENTED FEMORAL STEM/CEMENTED LONG FEMORAL STEM Exactech, Inc. | JDI |
| Sep 19, 1996 | K962560 | VITALITY HIP STEM Encore Orthopedics, Inc. | JDI |
| Sep 17, 1996 | K960984 | SHP HIP SYSTEM-FEMORAL COMPONENTS/ACETABULAR COMPONENTS/MODULAR HEADS/CENTRALIZERS Biomet, Inc. | JDI |
| Sep 17, 1996 | K960647 | OMEGA TOTAL HIP SYSTEM FOR CEMENTED APPLICATIONS Osteoimplant Technology, Inc. | JDI |
| Sep 10, 1996 | K962267 | PERFECTA PS REVISION STEM Wrightmedicaltechnologyinc | JDI |
| Aug 7, 1996 | K962086 | CPS, CEMENTED CUP SYSTEM Artos Medical Products GmbH | JDI |
| Aug 1, 1996 | K961899 | CPS, CEMENTED HIP SYSTEM Artos Medical Products GmbH | JDI |
| Jul 25, 1996 | K960278 | COBALT-CHROMIUM-MOLYBDENUM (CO-CR-MO) ALLOY FEMORAL HEADS W/CO-NIDIUM SURFACE TREATMENT Zimmer, Inc. | JDI |
| Jul 16, 1996 | K960658 | COLLARLESS POLISHED TAPER HIP PROSTHESIS Zimmer, Inc. | JDI |
| Jul 15, 1996 | K961799 | NATURAL HIP SYSTEM - DRG HIP STEM Intermedics Orthopedics | JDI |
| Jul 12, 1996 | K961619 | DEPUY ENDURANCE CALCAR HIP PROSTHESIS Depuy, Inc. | JDI |
| Jul 12, 1996 | K960258 | NATURAL HIP SYSTEM Intermedics Orthopedics | JDI |
| Jun 14, 1996 | K961890 | FOUNDATION 9MM FORGED CEMENTED STEM Encore Orthopedics, Inc. | JDI |
| Jun 7, 1996 | K960025 | PROTEK LOW PROFILE ACETABULAR CUP Intermedics Orthopedics | JDI |
| May 3, 1996 | K960678 | BURCH/SCHNEIDER REINFORCEMENT CAGE Intermedics Orthopedics | JDI |
| Apr 18, 1996 | K960626 | MODULAR ONCOLOGY SYSTEM TECHNOLOGY (MOST) Intermedics Orthopedics | JDI |
| Apr 4, 1996 | K954598 | OSTEONICS OFFSET HIP STEMS Osteonics Corp. | JDI |
| Apr 1, 1996 | K960302 | CONSENSUS ACETABULAR SHELL, ALL UHMWPE U.S. Medical Products, Inc. | JDI |
| Mar 15, 1996 | K960340 | CONSENSUS APEX DOME HOLE PLUG U.S. Medical Products, Inc. | JDI |
| Feb 21, 1996 | K960339 | CONSENSUS 22MM COCRMO FEMORAL HEAD U.S. Medical Products, Inc. | JDI |
| Feb 21, 1996 | K960156 | CONSENSUS 32MM COCRMO FEMORAL HEAD U.S. Medical Products, Inc. | JDI |
| Feb 21, 1996 | K960151 | CONSENSUS 26MM COCRMO FEMORAL HEAD U.S. Medical Products, Inc. | JDI |
| Feb 20, 1996 | K955620 | PRIME CEMENTED CALCAR FEMORAL STEMS Orthopaedic Innovations, Inc. | JDI |
| Feb 16, 1996 | K955473 | GAMMA SYSTEM Zimmer, Inc. | JDI |
| Feb 14, 1996 | K955296 | LINK MP RECONSTRUCTION HIP Link America, Inc. | JDI |
| Jan 31, 1996 | K953202 | P.F.C. SIZE 0 CEMENTED FEMORAL COMPONENT Johnson & Johnson Professionals, Inc. | JDI |
| Jan 31, 1996 | K953200 | ULTIMA SIZE 0 CEMENTED FEMORAL STEM Johnson & Johnson Professionals, Inc. | JDI |
| Jan 31, 1996 | K952859 | ULTIMA CEMENTED LONG STEM FEMORAL COMPONENT Johnson & Johnson Professionals, Inc. | JDI |
| Jan 24, 1996 | K955354 | ALTERNATIVE STERILIZATION PROCESS Howmedica Corp. | JDI |
| Jan 23, 1996 | K954744 | ZCH ALPHA SYSTEM Zimmer, Inc. | JDI |
| Jan 17, 1996 | K952970 | HOWMEDICA FEMORAL & PROXIMAL TIBIAL MODULAR REPLACEMENT SYTESM Howmedica Corp. | JDI |
| Dec 28, 1995 | K952731 | TOWNLEY ALL POLY ACETABULAR CUP Biologically Oriented Prostheses | JDI |
| Dec 28, 1995 | K945774 | BETA FEMORAL HIP STEM Wrightmedicaltechnologyinc | JDI |
| Dec 13, 1995 | K935585 | APR ACETABULAR INSERTS IOI BIPOLAR Intermedics Orthopedics | JDI |
| Dec 4, 1995 | K954219 | REALITY LONG STEM HIP SYSTEM Kinamed, Inc. | JDI |
| Nov 22, 1995 | K951139 | ALPHA LONG STEM FEMORAL COMPONENT (SUBJECT TO WMTI MARKETING APPROVAL) Wrightmedicaltechnologyinc | JDI |
| Nov 3, 1995 | K954262 | NEXUS II FEMORAL COMPONENT Wrightmedicaltechnologyinc | JDI |
| Oct 30, 1995 | K953578 | PROTEK ACETABULAR ROOF REINFORCEMENT RING Intermedics Orthopedics | JDI |
| Sep 13, 1995 | K953033 | PRIME CEMENTED SMALL FEMORAL STEM Orthopaedic Innovations, Inc. | JDI |
| Sep 8, 1995 | K953025 | SLT 28MM XXL FEMORAL HEAD Wrightmedicaltechnologyinc | JDI |
| Sep 8, 1995 | K952629 | NEXFLEX TOTAL HIP SYSTEM Nexmed, Inc. | JDI |
| Jul 18, 1995 | K934857 | HSS FEMORAL COMPONENTS Hospital For Special Surgery | JDI |
| Jul 17, 1995 | K952191 | FORGED CEMENTED STEM Encore Orthopedics, Inc. | JDI |
| Jul 11, 1995 | K935263 | FOUNDATION POROUS STEM Encore Orthopedics, Inc. | JDI |
| Jun 30, 1995 | K952461 | ENDO PROSTHESIS FEMORAL HEAD Stelkast Company | JDI |
| Jun 21, 1995 | K951726 | S-ROM ZTP UHMWPE ACETABULAR CUP Joint Medical Products Corp. | JDI |
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