K253566 is an FDA 510(k) clearance for the Affixus Retrograde Femoral Nailing System. This device is classified as a Rod, Fixation, Intramedullary And Accessories (Class II - Special Controls, product code HSB).
Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 12, 2026, 115 days after receiving the submission on November 17, 2025.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3020.
| 510(k) Number | K253566 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 17, 2025 |
| Decision Date | March 12, 2026 |
| Days to Decision | 115 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HSB — Rod, Fixation, Intramedullary And Accessories |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3020 |