# K150443: ToeTac Hammertoe Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Restore Surgical, LLC Dba Instratek
- Decided: Jun 4, 2015 after 104 days
- Product code: HWC (Screw, Fixation, Bone)
- 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: 8 generations back to K962823 (1996). 68 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133636: Extremity Medical Hammertoe Device, Extremity Medical, LLC (2014) Summary page 4.
- K112254: Apex Kirschner Wires and Steinmann Pins, Apex Tools & Orthopedics Co. (2011) Summary page 4.

## Most influential descendants
- K161778: ToeTac™ 10° Hammertoe Fixation System (2016), 0 descendants of its own

## Indications for use
The ToeTacTM Hammertoe Fixation System indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.

Source page: https://510kreport.com/device/K150443
Methodology: https://510kreport.com/methodology