ZipToe Hammertoe Fusion System— 510(k) K253325

Substantially Equivalent

Toetal Solutions

FDA 510(k) clearance K253325 for ZipToe Hammertoe Fusion System, Substantially Equivalent on 2025-12-29. Applicant: Toetal Solutions.

Clearance details

Applicant: Toetal Solutions
Product code: Code HTY
Advisory panel: Orthopedic
Date received: 2025-09-30
Decision date: 2025-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HTY

product code HTY

Injury: 544
Total: 544

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.