K253749 is an FDA 510(k) clearance for the Affixus® Natural Nail® Proximal Humeral System. This device is classified as a Rod, Fixation, Intramedullary And Accessories (Class II - Special Controls, product code HSB).
Submitted by Zimmer Switzerland Manufacturing GmbH (Winterthur, CH). The FDA issued a Cleared decision on December 12, 2025, 17 days after receiving the submission on November 25, 2025.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3020.
| 510(k) Number | K253749 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 25, 2025 |
| Decision Date | December 12, 2025 |
| Days to Decision | 17 days |
| Submission Type | Special |
| 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 |