K253325 is an FDA 510(k) clearance for the ZipToe™ Hammertoe Fusion System. This device is classified as a Pin, Fixation, Smooth (Class II - Special Controls, product code HTY).
Submitted by Toetal Solutions (Malvern, US). The FDA issued a Cleared decision on December 29, 2025, 90 days after receiving the submission on September 30, 2025.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K253325 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2025 |
| Decision Date | December 29, 2025 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HTY - Pin, Fixation, Smooth |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |