# K161778: ToeTac™ 10° Hammertoe Fixation System

- Pathway: 510(k) (Traditional)
- Applicant: Restore Surgical, LLC Dba Instratek
- Decided: Nov 22, 2016 after 146 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: 9 generations back to K962823 (1996). 69 ancestors in all.
No later device cites it as a predicate yet.
0 of 70 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150443: ToeTac Hammertoe Fixation System, Restore Surgical, LLC Dba Instratek (2015) Summary page 4.
- K112254: Apex Kirschner Wires and Steinmann Pins, Apex Tools & Orthopedics Co. (2011) Summary page 4.

## Indications for use
The ToeTac™ 10° Fixation System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for the hammertoe, claw toe, and mallet toe.

Source page: https://510kreport.com/device/K161778
Methodology: https://510kreport.com/methodology