510(k) K952970 ยท JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
HOWMEDICA FEMORAL & PROXIMAL TIBIAL MODULAR REPLACEMENT SYTESM
| Applicant | Howmedica Corp., Rutherford NJ, US |
| Decision | Substantially Equivalent, Jan 17, 1996 |
| Received | Jun 27, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K952970
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 26, 2008 | Stryker Howmedica Osteonics Corp. Stryker Modular Replacement System Curved Cemented Stem; MRS SM Curved Femoral Stem 10x102; Catalog Number: 6485-3-300; Stryker Orthopaedics Mahwah, NJ 07430 Terminated |
JDI | None listed |
| Feb 26, 2008 | Stryker Howmedica Osteonics Corp. Stryker Modular Replacement System Curved Cemented Stem;
MRS Small Curved Femoral Stem 8x102. Catalog Number 6485-3-308; Stryker Orthopaedics Mahwah, NJ 07430 Terminated |
JDI | None listed |
| Feb 26, 2008 | Stryker Howmedica Osteonics Corp. Stryker Modular Replacement System Curved Cemented Stem;
MRS Small Curved Femoral Stem 9 x 102. Catalog Number: 6485-3-309; Stryker Orthopaedics Mahwah, NJ 07430 Terminated |
JDI | None listed |
| Feb 26, 2008 | Stryker Howmedica Osteonics Corp. Stryker Modular Replacement System Curved Cemented Stem;
MRS 11mmx203mm femoral stem. Catalog Number: 6485-3-311; Stryker Orthopaedics Mahwah, NJ 07430 Terminated |
JDI | None listed |
| Feb 26, 2008 | Stryker Howmedica Osteonics Corp. Stryker Modular Replacement System Curved Cemented Stem;
MRS 12mmx203 Femoral Stem. Catalog Number: 6485-3-313; Stryker Orthopaedics Mahwah, NJ 07430 Terminated |
JDI | None listed |
| Feb 26, 2008 | Stryker Howmedica Osteonics Corp. Stryker Modular Replacement System Curved Cemented Stem;
MRS 15mmx203mm Femoral Stem. Catalog Number: 6485-3-315; Stryker Orthopaedics Mahwah, NJ 07430 Terminated |
JDI | None listed |
| Feb 26, 2008 | Stryker Howmedica Osteonics Corp. Stryker Modular Replacement System Curved Cemented Stem;
MRS 17mmx203 Femoral Stem. Catalog Number 6485-3-317; Stryker Orthopaedics Mahwah, NJ 07430 Terminated |
JDI | None listed |
| Feb 26, 2008 | Stryker Howmedica Osteonics Corp. Stryker Modular Replacement System Curved Cemented Stem;
MRS 11x127 Curved Femoral Stem. Catalog Number: 6485-3-711; Stryker Orthopaedics Mahwah, NJ 07430 Terminated |
JDI | None listed |
| Feb 26, 2008 | Stryker Howmedica Osteonics Corp. Stryker Modular Replacement System Curved Cemented Stem;
MRS 13x127 Curved Femoral Stem. Catalog Number: 6485-3-713; Stryker Orthopaedics Mahwah, NJ 07430 Terminated |
JDI | None listed |
| Feb 26, 2008 | Stryker Howmedica Osteonics Corp. Stryker Modular Replacement System Curved Cemented Stem;
MRS 15x127 Curved Femoral Stem. Catalog Number: 6485-3-715; Stryker Orthopaedics Mahwah, NJ 07430 Terminated |
JDI | None listed |
| Feb 26, 2008 | Stryker Howmedica Osteonics Corp. Stryker Modular Replacement System Curved Cemented Stem;
MRS 17x127 Curved Femoral Stem. Catalog Number: 6485-3-717; Stryker Orthopaedics Mahwah, NJ 07430 Terminated |
JDI | None listed |
| 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 | None listed |
| Feb 27, 2003 | Stryker Howmedica Osteonics Modular Replacement System with Extra-Cortical Porous Coating, Femoral Module Stem and Tibial Module Stem Terminated |
JDI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.