Cleared Traditional

ZipToe? Hammertoe Fusion System

K253325 · Toetal Solutions · Orthopedic

Dec 2025

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K253325 is an FDA 510(k) clearance for the ZipToe? Hammertoe Fusion System, 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 review panel. Regulated under 21 CFR 888.3040.

Submission Details

510(k) Number	K253325 FDA.gov
FDA Decision	Cleared 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