# K170350: ToeMATE® Hammertoe Correction System

- Pathway: 510(k) (Special)
- Applicant: Arthrosurface, Inc.
- Decided: Mar 3, 2017 after 28 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: 5 generations back to K960385 (1996). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130859: Hammertoe Correction System, Arthrosurface, Inc. (2013) Summary page 5.
- K101165: Pro-Toe VO Hammertow Implant System, Wrightmedicaltechnologyinc (2010) Summary page 5.
- K120645: Pro-Toe (TM) VO Hamertoe Implant System-Line Sddition, Wrightmedicaltechnologyinc (2012) Summary page 5.

## Indications for use
Indicated for small bone fusion, fractures and inter-digital fusion of the fingers, toes and small bones.

Source page: https://510kreport.com/device/K170350
Methodology: https://510kreport.com/methodology