510(k) K171768 · LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Trident® II Acetabular System
| Applicant | Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics, Mahwah NJ, US |
| Decision | Substantially Equivalent, Oct 2, 2017 |
| Received | Jun 14, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171768
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 25, 2024 | Howmedica Osteonics Corp. TRIDENTII HEMI CLUSTER44B- Indicated for use in primary and revision patients at high risk of hip dislocation
Catalog Number: 702-11-44B Open, Classified |
LPH | None listed |
| Apr 25, 2024 | Howmedica Osteonics Corp. TRIDENTII HEMI CLUSTER48D-indicated for use in primary and revision patients at high risk of hip dislocation
Catalog Number: 702-11-48D Open, Classified |
LPH | None listed |
| Apr 25, 2024 | Howmedica Osteonics Corp. TRIDENTII HEMI CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation
Catalog Number: 702-11-50D Open, Classified |
LPH | None listed |
| Apr 25, 2024 | Howmedica Osteonics Corp. TRIDENTII HEMI CLUSTER52E-Indicated for use in primary and revision patients at high risk of hip dislocation
Catalog Number: 702-11-52E Open, Classified |
LPH | None listed |
| Apr 25, 2024 | Howmedica Osteonics Corp. TRIDENTII HEMI CLUSTER54E- Indicated for use in primary and revision patients at high risk of hip dislocation
Catalog Number: 702-11-54E Open, Classified |
LPH | None listed |
| Apr 25, 2024 | Howmedica Osteonics Corp. TRIDENTII HEMI CLUSTER58F- Indicated for use in primary and revision patients at high risk of hip dislocation
Catalog Number: 702-11-58F Open, Classified |
LPH | None listed |
| Apr 25, 2024 | Howmedica Osteonics Corp. TRIDENTII HEMI CLUSTER66H- Indicated for use in primary and revision patients at high risk of hip dislocation
Catalog Number: 702-11-66H Open, Classified |
LPJ | None listed |
| Apr 25, 2024 | Howmedica Osteonics Corp. TRIDENTII PSL CLUSTER48D- Indicated for use in primary and revision patients at high risk of hip dislocation
Catalog Number: 742-11-48D Open, Classified |
LPH | None listed |
| Apr 25, 2024 | Howmedica Osteonics Corp. TRIDENTII PSL CLUSTER50D- Indicated for use in primary and revision patients at high risk of hip dislocation
Catalog Number: 742-11-50D Open, Classified |
LPH | None listed |
| Apr 25, 2024 | Howmedica Osteonics Corp. TRIDENTII PSL CLUSTER52E- Indicated for use in primary and revision patients at high risk of hip dislocation
Catalog Number: 742-11-52E Open, Classified |
LPH | None listed |
| Apr 25, 2024 | Howmedica Osteonics Corp. TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation
Catalog Number: 742-11-58F Open, Classified |
LPH | None listed |
| Apr 25, 2024 | Howmedica Osteonics Corp. TRIDENTII PSL CLUSTER64H- Indicated for use in primary and revision patients at high risk of hip dislocation
Catalog Number: 742-11-64H Open, Classified |
LPH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.