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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 24, 2003 | Biomet, Inc. Stanmore modular hip system; Stanmore CoCr femoral size 3 std. stem; part 164243 Terminated |
JDI | K911684 |
| Sep 24, 2003 | Biomet, Inc. Stanmore modular hip system; Stanmore CoCr femoral size 2 std. stem; part 164242 Terminated |
JDI | K911684 |
| Sep 24, 2003 | Biomet, Inc. Stanmore modular hip system; Stanmore CoCr femoral size 1 std. stem; part 164241 Terminated |
JDI | K911684 |
| Feb 27, 2003 | Stryker Howmedica Osteonics Modular Replacement System with Extra-Cortical Porous Coating, Femoral Module Stem and Tibial Module Stem Terminated |
JDI | K952970 |
| Feb 27, 2003 | Stryker Howmedica Osteonics Modular femoral and proximal tibial replacement system consisting of femoral head/neck, body, stem and condyle components. Also proximal tibial body rotating hinge-type knee and stem components. Terminated |
JDI | K952970 |
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