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 2, 2008 | K080539 | ACCIN UNIPOLAR HEAD SYSTEM Accelerated Innovation, LLC | JDI |
| Apr 28, 2008 | K080885 | MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION Medacta International S.A. | JDI |
| Feb 4, 2008 | K072857 | TOTAL HIP PROSTHESIS SYSTEM QUADRA S + COCRMO FEMORAL BALL HEAD + APRICOT Medacta International S.A. | JDI |
| May 4, 2007 | K070399 | 100KGY E-POLY ACETABULAR LINERS-ADDITIONAL PROFILES Biomet Manufacturing, Inc. | JDI |
| May 3, 2007 | K070364 | 100KGY E-POLY MAXROM ACETABULAR LINERS Biomet, Inc. | JDI |
| Jan 12, 2007 | K063278 | PORTLAND COBALT CHROME FEMORAL HEAD Portland Orthopaedics Limited | JDI |
| Aug 2, 2006 | K061344 | EXCIA TOTAL HIP SYSTEM LATERAL OFFSET Aesculap, Inc. | JDI |
| May 3, 2006 | K052639 | GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS WITH PROXIMAL CEMENT SPACER Biomet Manufacturing, Inc. | JDI |
| Dec 2, 2005 | K052748 | SYSTEM 12 X3 ACETABULAR INSERTS; SERIES II X3 ACETABULAR INSERTS Howmedica Osteonics Corp. | JDI |
| Oct 7, 2005 | K052792 | ANTHOLOGY HIP STEM Smith & Nephew, Inc. | JDI |
| Sep 29, 2005 | K051569 | RINGLOC BI-POLAR ACETABULAR COMPONENT Biomet, Inc. | JDI |
| Sep 23, 2005 | K050637 | ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HEADS Ortho Development Corp. | JDI |
| Sep 8, 2005 | K051407 | LEGEND ALL-POLY CUP Ortho Development Corp. | JDI |
| Jul 27, 2005 | K051516 | TRABECULAR METAL REVISION SHELL LINERS Zimmer, Inc. | JDI |
| Jun 29, 2005 | K050441 | TAPER 2 POROUS FEMORAL STEM Biomet, Inc. | JDI |
| Jun 23, 2005 | K051363 | RESTORATION MODULAR SYSTEM Howmedica Osteonics Corp. | JDI |
| Jun 21, 2005 | K051335 | ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS Exactech, Inc. | JDI |
| May 17, 2005 | K050105 | NEXGEN COMPLETE KNEE SOLUTION DISTAL FEMORAL SPACERS Zimmer, Inc. | JDI |
| Mar 21, 2005 | K050138 | MODIFICATION TO: RESTORATION MODULAR SYSTEM Howmedica Osteonics Corp. | JDI |
| Dec 22, 2004 | K042959 | DEPUY C-STEM AMT HIP PROSTHESIS DePuy Orthopaedics, Inc. | JDI |
| Apr 16, 2004 | K033871 | IM TOTAL FEMUR Biomet, Inc. | JDI |
| Mar 26, 2004 | K032730 | FIXION HIP SYSTEM Disc-O-Tech Medical Technologies, Ltd., IL | JDI |
| Mar 11, 2004 | K034028 | ATH FEMORAL STEM Wrightmedicaltechnologyinc | JDI |
| Oct 15, 2003 | K031474 | SC TOTAL HIP SYSTEM Orthopedic Alliance, LLC | JDI |
| Sep 22, 2003 | K030867 | ESKA MODULAR HIP SYSTEM CEMENTED Eska Implants GmbH | JDI |
| Aug 29, 2003 | K031730 | 36MM ORTHINOX V40 FEMORAL HEAD COMPONENTS Howmedica Osteonics Corp. | JDI |
| Aug 21, 2003 | K032396 | RINGLOC 36MM LINE AND MODULAR FEMORAL HEADS Biomet, Inc. | JDI |
| Aug 8, 2003 | K031744 | OMNIFIT HFX HIP STEM SERIES Howmedica Osteonics Corp. | JDI |
| Jul 25, 2003 | K030766 | OXINIUM FEMORAL HEADS Smith & Nephew, Inc. | JDI |
| Jul 1, 2003 | K031734 | GENERATION 4 POLISHED FEMORAL HIP PROSTHESIS Biomet, Inc. | JDI |
| Jun 6, 2003 | K031165 | PLUS ORTHOPEDICS CEMENTED HIP STEM Plus Orthopedics | JDI |
| Apr 1, 2003 | K030153 | ZCA ALL-POLY ACETABULAR CUP, SNAP-IN, MODEL 8005-946/958-32 Zimmer, Inc. | JDI |
| Mar 4, 2003 | K030265 | CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00 Zimmer, Inc. | JDI |
| Feb 26, 2003 | K024340 | SMITH & NEPHEW FEMORAL HEADS Smith & Nephew, Inc. | JDI |
| Nov 21, 2002 | K022799 | TRIDENT SCREW HOLE PLUG AND TRIDENT BONE SPIKE Howmedica Osteonics Corp. | JDI |
| Nov 13, 2002 | K023646 | EXATECH ACUMATCH INTEGRATED HIP SYSTEM C-SERIES CEMENTED FEMORAL STEM Exactech, Inc. | JDI |
| Nov 13, 2002 | K023453 | DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS DePuy Orthopaedics, Inc. | JDI |
| Oct 17, 2002 | K023085 | RX 90 FEMORAL STEM AND RX 90 LATERALIZED FEMORAL STEM Biomet Orthopedics, Inc. | JDI |
| Oct 2, 2002 | K022958 | TOTAL HIP FEMORAL HEADS AND LINERS Smith & Nephew, Inc. | JDI |
| Jul 25, 2002 | K022094 | PAR 5 ACETABULAR COMPONENT WITH & WITHOUT HYDROXYAPATITE COATING Biomet, Inc. | JDI |
| Jul 25, 2002 | K022077 | 36MM V40 FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) Howmedica Osteonics Corp. | JDI |
| Jul 23, 2002 | K021822 | R120 MODULAR TOTAL HIP SYSTEM Osteoimplant Technology, Inc. | JDI |
| May 28, 2002 | K021380 | OSS LES PROXIMAL FEMORAL COMPONENT Biomet, Inc. | JDI |
| May 21, 2002 | K021310 | 36MM C-TAPER FEMORAL HEAD COMPONENTS (LFIT AND NON-LFIT) Howmedica Osteonics Corp. | JDI |
| May 14, 2002 | K021178 | SL-PLUS LATERALIZED STEM Plus Orthopedics | JDI |
| Apr 26, 2002 | K020989 | SUPER EON PLUS FEMORAL STEMS Howmedica Osteonics Corp. | JDI |
| Apr 4, 2002 | K020970 | MODIFICATION TO ONCOLOGY SALVAGE SYSTEM (OSS) Biomet, Inc. | JDI |
| Feb 27, 2002 | K020291 | EXACTECH, MODEL PMMA FEMORAL STEM CENTRALIZER Exactech, Inc. | JDI |
| Jan 30, 2002 | K020076 | PATRIOT PROTRUSIO CAGE Biomet Orthopedics, Inc. | JDI |
| Dec 27, 2001 | K011887 | AVALON CUP SYSTEM Orthopedic Source, Inc. | JDI |
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