K241609 is an FDA 510(k) clearance for the Tornier Humeral Reconstruction System (Tornier HRS). This device is classified as a Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented (Class II - Special Controls, product code KWS).
Submitted by Stryker Corporation (Tornier, Inc.) (Bloomington, US). The FDA issued a Cleared decision on September 10, 2024, 97 days after receiving the submission on June 5, 2024.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3660.
| 510(k) Number | K241609 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 05, 2024 |
| Decision Date | September 10, 2024 |
| Days to Decision | 97 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | KWS — Prosthesis, Shoulder, Semi-constrained, Metal/polymer Cemented |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3660 |