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 17, 2001 | K013352 | SUMMIT CEMENTED HIP PROSTHESIS DePuy Orthopaedics, Inc. | JDI |
| Nov 7, 2001 | K013350 | MODIFICATION TO DEPUY C-STEM SYSTEM DePuy Orthopaedics, Inc. | JDI |
| Oct 18, 2001 | K012961 | SULZER ORTHOPEDICS CONVERGE ACETABULAR SYSTEM Sulzer Orthopedics, Inc. | JDI |
| Sep 5, 2001 | K011774 | R120 MODULAR TOTAL HIP SYSTEM Osteoimplant Technology, Inc. | JDI |
| Aug 29, 2001 | K012493 | ACUMATCH C-SERIES CEMENTED FEMORAL COMPONENT, MODEL SIZE 0 Exactech, Inc. | JDI |
| Aug 27, 2001 | K011715 | MACROPORE IB RESORBABLE PLUG Macropore Biosurgery, Inc. | JDI |
| Jul 20, 2001 | K012019 | COLOR BUFFED (CB) DDH FEMORAL STEM Biomet, Inc. | JDI |
| Jul 18, 2001 | K012026 | TRIDENT ALL POLY CUP Howmedica Osteonics Corp. | JDI |
| Jul 18, 2001 | K011455 | BIOMET ONCOLOGY SALVAGE SYSTEM (OSS) TAPER STACKING ADAPTER Biomet, Inc. | JDI |
| Jun 15, 2001 | K011623 | EXETER HIP SYSTEM WITH V40 TAPER Howmedica Osteonics Corp. | JDI |
| Jun 15, 2001 | K011367 | EXCEL FRACTURE CEMENTED HIP STEM DePuy Orthopaedics, Inc. | JDI |
| May 16, 2001 | K011218 | ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL SIZE 1 Exactech, Inc. | JDI |
| Apr 27, 2001 | K010529 | TITANIUM CEMENT RESTRICTOR MATERIAL PLDLA Medtronic Sofamor Danek USA, Inc. | JDI |
| Apr 11, 2001 | K010757 | LFIT V40 FEMORAL HEAD COMPONENTS Howmedica Osteonics Corp. | JDI |
| Mar 20, 2001 | K010310 | MODIFICATION TO TRIDENT ALL POLY CUP Howmedica Osteonics Corp. | JDI |
| Mar 19, 2001 | K003976 | BAUMER MULLER HIP PROSTHESIS Baumer, S.A, BR | JDI |
| Mar 19, 2001 | K003975 | BAUMER CEMENTED HIP PROSTHESIS Baumer, S.A, BR | JDI |
| Feb 8, 2001 | K003666 | TAPER-FIT TOTAL HIP SYSTEM Corin USA | JDI |
| Dec 11, 2000 | K001956 | TRIDENT ALL POLY CUP Howmedica Osteonics Corp. | JDI |
| Dec 1, 2000 | K003421 | DEPUY C-STEM SYSTEM DePuy Orthopaedics, Inc. | JDI |
| Nov 24, 2000 | K002757 | ONCOLOGY SALVAGE SYSTEM Biomet, Inc. | JDI |
| Aug 24, 2000 | K002324 | MODIFIED TO MODULAR FR SEVERE BONE LOSS TRAUMA Sulzermedica | JDI |
| Aug 24, 2000 | K001759 | HEDROCEL REVISION CUP, MODEL 02-2YY-ZZZZ Implex Corp. | JDI |
| Aug 4, 2000 | K001571 | BAUMER FEMORAL HEAD Baumer, S.A, BR | JDI |
| Jul 27, 2000 | K002106 | NEW BIO-MOORE ENDO HEAD, TAPER ADAPTER Biomet, Inc. | JDI |
| Jul 20, 2000 | K001932 | TORNIER CEMENT RESTRICTOR Tornier | JDI |
| Jul 20, 2000 | K001376 | TI-MAX PROTRUSIO CAGE Biomet, Inc. | JDI |
| Jun 23, 2000 | K001078 | SULZER ORTHOPEDICS MS-30 FEMORAL STEM Sulzer Orthopedics, Inc. | JDI |
| Jun 20, 2000 | K001733 | ALLEN MEDULLARY CEMENT PLUGS, ZIMMER POLY PLUG INTRAMEDULLARY SYSTEM, MODEL 8011 SERIES & 1109 & 8109 SERIES Zimmer, Inc. | JDI |
| Jun 8, 2000 | K000817 | OMEGA II MODULAR TOTAL HIP SYSTEM Osteoimplant Technology, Inc. | JDI |
| May 18, 2000 | K001335 | ACUMATCH L-SERIES CEMENTED FEMORAL STEM, MODEL L-SERIES CEMENTED Exactech, Inc. | JDI |
| Mar 1, 2000 | K990330 | CROSS LINKED POLYETHYLENE ACETABULAR COMPONENTS,MODEL XX-YY-ZZZZZZ Implex Corp. | JDI |
| Feb 7, 2000 | K000254 | PAR 5 ACETABULAR COMPONENT Biomet, Inc. | JDI |
| Feb 4, 2000 | K994007 | MALLORY/HEAD SMOOTH FEMORAL COMPONENT Biomet, Inc. | JDI |
| Jan 28, 2000 | K993713 | RIM-FIX, ACETABULAR CUP Surgical Implants, Inc. | JDI |
| Oct 8, 1999 | K992409 | THE IMPLEX MODULAR ELLIPTICAL POROUS ACETABULAR CUP, MODEL XX-2YY-ZZZZ Implex Corp. | JDI |
| Sep 23, 1999 | K992153 | PE-PLUS ACETABULAR CUP Plus Orthopedics | JDI |
| Sep 17, 1999 | K992903 | COLOR BUFFED CEMENTED FEMORAL Biomet, Inc. | JDI |
| Aug 19, 1999 | K992490 | B2C HIP SYSTEM Lepine Groupe Spa. | JDI |
| Jul 14, 1999 | K991869 | COBREX HIP STEM, MODEL 01-128-XXXXX Implex Corp. | JDI |
| Jul 14, 1999 | K991622 | 26 MM CAST COCR HEAD AND POLYETHYLENE ACETABULAR SHELL LINER Stelkast Company | JDI |
| Jul 1, 1999 | K992058 | BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEM Biomet, Inc. | JDI |
| Jun 28, 1999 | K991987 | COLOR BUFFED ANSWER CEMENTED FEMORAL Biomet, Inc. | JDI |
| Jun 3, 1999 | K991538 | OPERA CUPFLANGED ACETABULAR COMPONENTS Smith & Nephew, Inc., Orthopaedic Div. | JDI |
| Jun 1, 1999 | K991227 | 8MM FORGED CEMENTED STEM Encore Orthopedics, Inc. | JDI |
| Apr 29, 1999 | K990821 | PROVIDENCE CUP SYSTEM Biopro, Inc. | JDI |
| Apr 8, 1999 | K984227 | OMEGA II MODULAR TOTAL HIP SYSTEM Osteoimplant Technology, Inc. | JDI |
| Mar 12, 1999 | K990369 | SYNERGY CEMENTED HIP STEM Smith & Nephew, Inc. | JDI |
| Feb 18, 1999 | K990032 | MODULAR PROTUSIO CUP Biomet, Inc. | JDI |
| Feb 11, 1999 | K984154 | APF POROUS COATED LINE EXTENSION Biomet, Inc. | JDI |
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