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 |
|---|---|---|---|
| Apr 14, 1993 | K915594 | STABILITY HIP FEMORAL COMPONENT Depuy, Inc. | JDI |
| Apr 8, 1993 | K923275 | RMHS MONOLITHIC FEMORAL COMPONENT Smith & Nephew Richards, Inc. | JDI |
| Apr 6, 1993 | K922847 | PERFECTA TOTAL HIP SYSTEM Orthomet, Inc. | JDI |
| Feb 23, 1993 | K911058 | TECHMEDICA CAD/CAM CUSTOM HIP Techmedica, Inc. | JDI |
| Feb 12, 1993 | K924323 | THE UNIVERSAL BONE CEMENT RESISTOR Biodynamic Technologies, Inc. | JDI |
| Feb 12, 1993 | K922871 | UNIFIT FEMORAL STEM Osteo Technology, Inc. | JDI |
| Feb 12, 1993 | K922866 | OTI BONE PLUG Osteo Technology, Inc. | JDI |
| Feb 12, 1993 | K922864 | MUELLER TYPE FEMORAL STEM Osteo Technology, Inc. | JDI |
| Feb 12, 1993 | K922863 | EUROSTEM HIP PROTHESIS SYSTEM Osteo Technology, Inc. | JDI |
| Feb 12, 1993 | K922862 | CHARNLEY TYPE HIP PROTHESIS Osteo Technology, Inc. | JDI |
| Feb 12, 1993 | K922860 | AUSTIN-MOORE TYPE HIP PROSTHESIS Osteo Technology, Inc. | JDI |
| Feb 9, 1993 | K925895 | ETEX HIP REPLACEMENT SYSTEM Etex Co. | JDI |
| Feb 9, 1993 | K922733 | PERFECTA TOTAL HIP SYSTEM AND PROFORMA TOTAL HIP Orthomet, Inc. | JDI |
| Jan 7, 1993 | K922645 | LSF ANATOMIC CEMENTED HIP Osteo Technology, Inc. | JDI |
| Jan 7, 1993 | K914078 | DEPUY HIP PROSTHESIS Depuy, Inc. | JDI |
| Nov 24, 1992 | K924115 | ULTIMA ALL UHMWPE CEMENTED ACETABULAR CUPS Johnson & Johnson Orthopaedics, Inc. | JDI |
| Nov 24, 1992 | K920739 | S-ROM TOTAL HIP REPLACEMENT SYSTEM Joint Medical Products Corp. | JDI |
| Nov 4, 1992 | K923898 | C-FIT CEMENTED HIP STEM Turnkey Intergration USA, Inc. | JDI |
| Oct 20, 1992 | K915500 | LESTER PRESS FIT HIP PROSTHESIS Kirschner Medical Corp. | JDI |
| Oct 15, 1992 | K922421 | KINAMED ATH-POROUS AND ATH-POROUS LONG TOTAL HIP Kinamed, Inc. | JDI |
| Sep 21, 1992 | K922503 | HOWMEDICA(R) HNR SYSTEM Howmedica Corp. | JDI |
| Aug 7, 1992 | K914675 | MODULAR FEMORAL HEAD WITH OFFSET TRUNION Kirschner Medical Corp. | JDI |
| Jul 30, 1992 | K922008 | CDH HIP SYSTEM Howmedica, Pfizer Medical Technology Group | JDI |
| Jul 30, 1992 | K914878 | ZIRCONIUM ALLOY FRMORAL HEAD Smith & Nephew Richards, Inc. | JDI |
| Jul 21, 1992 | K920430 | MODULAR ACETABULAR CUP SYSTEM Smith & Nephew Richards, Inc. | JDI |
| Jun 30, 1992 | K920640 | FULL HEMISPHERE RING-LOC LINER Biomet, Inc. | JDI |
| Jun 30, 1992 | K920639 | RX 90 ACETABULAR COMPONENT SYSTEM Biomet, Inc. | JDI |
| Jun 25, 1992 | K921383 | PRECISION STRATA TOTAL HIP STEM Howmedica Corp. | JDI |
| Apr 21, 1992 | K920286 | DEPUY TOTAL HIP BALLS - ION IMPLANTATION Depuy, Inc. | JDI |
| Apr 20, 1992 | K920250 | OSTEONICS MICROSURFACED CDH HIP STEM Stryker Corp. | JDI |
| Apr 13, 1992 | K920161 | BIOMET NTS FEMORAL COMPONENTS Biomet, Inc. | JDI |
| Mar 25, 1992 | K920021 | LSF TOTAL HIP SYSTEM - MULLER-TYPE ACETABULAR CUP Implant Technology, Inc. | JDI |
| Mar 19, 1992 | K920317 | S-ROM LF FEMORAL HEAD Joint Medical Products Corp. | JDI |
| Mar 13, 1992 | K920003 | DRG CEMETED STEM Intermedics Orthopedics | JDI |
| Mar 4, 1992 | K915795 | PERFECTA PDA TOTAL HIP SYSTEM Orthomet, Inc. | JDI |
| Feb 11, 1992 | K915216 | SOLUTION SYSTEM CUP Depuy, Inc. | JDI |
| Jan 2, 1992 | K911802 | PMI (PATIENT MATCHED IMPLANTS) HIP FEMORAL COMP Biomet, Inc. | JDI |
| Dec 20, 1991 | K914406 | PT II DISTAL CEMENT SPACER Osteonics Corp. | JDI |
| Dec 20, 1991 | K913231 | S-ROM(TM) TOTAL LHIP SYSTEM W/CERAMIC HEAD Joint Medical Products Corp. | JDI |
| Dec 20, 1991 | K912712 | BIOMET MODULAR TOTAL HIP FEMORAL COMPONENTS Biomet, Inc. | JDI |
| Dec 16, 1991 | K913634 | APR II HIP SYSTEM Intermedics Orthopedics | JDI |
| Nov 27, 1991 | K913874 | INFINITY(TM) MICROTAPER HIP SYSTEM Dow Corning Wright | JDI |
| Nov 22, 1991 | K913812 | OMNIFIT/OMNIFLEX/ODC/OMNIFIT-HA HIP STEM SERIES Osteonics Corp. | JDI |
| Nov 13, 1991 | K913649 | MODULAR CALCAR REPLACEMENT Zimmer, Inc. | JDI |
| Nov 7, 1991 | K913616 | LSF DIAGNOSTIC RELATED GROUP CEMENTED HIP Implant Technology, Inc. | JDI |
| Oct 18, 1991 | K913246 | HYBRID FIT TOTAL HIP SYSTEM Kirschner Medical Corp. | JDI |
| Oct 11, 1991 | K913208 | APR II NON-POROUS HIP STEM Intermedics Orthopedics | JDI |
| Oct 11, 1991 | K913060 | NATURAL POROUS HIP SYSTEM Intermedics Orthopedics | JDI |
| Oct 2, 1991 | K912593 | MODULAR HIP SYSTEM Smith & Nephew Richards, Inc. | JDI |
| Sep 27, 1991 | K912916 | APR COLLAR SPACER Intermedics Orthopedics | JDI |
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