# K253325: ZipToe™ Hammertoe Fusion System

- Pathway: 510(k) (Traditional)
- Applicant: Toetal Solutions
- Decided: Dec 29, 2025 after 90 days
- Product code: HTY (Pin, Fixation, Smooth)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K960385 (1996). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201715: Smart Toe II, X Fuse, Stryker GmbH (2020) Summary page 5.
- K050259: Arthrex Bio-Pin, Arthrex, Inc. (2005) Summary page 5.

## Indications for use
The ZipToe™ Hammertoe Fusion System is indicated for interphalangeal fusion of the toes.

Source page: https://510kreport.com/device/K253325
Methodology: https://510kreport.com/methodology