K191358 is an FDA 510(k) clearance for the Trident II Acetabular System. This device is classified as a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II - Special Controls, product code LPH).
Submitted by Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics (Mahwah, US). The FDA issued a Cleared decision on October 24, 2019, 156 days after receiving the submission on May 21, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3358.
| 510(k) Number | K191358 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 21, 2019 |
| Decision Date | October 24, 2019 |
| Days to Decision | 156 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | LPH — Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3358 |