# K130859: Hammertoe Correction System

- Pathway: 510(k) (Traditional)
- Applicant: Arthrosurface, Inc.
- Decided: Jul 25, 2013 after 119 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: 4 generations back to K960385 (1996). 9 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110445: Flexfusion (TM) Fixation Implant, Nextremity Solutions, LLC (2011) Summary page 2.
- K101165: Pro-Toe VO Hammertow Implant System, Wrightmedicaltechnologyinc (2010) Summary page 2.
- K990804: Stayfuse, Pioneer Surgical Technology (1999) Summary page 2.

## Most influential descendants
- K183228: HammerToe Compression System (2019), 0 descendants of its own
- K162685: 2-Piece Hammertoe Correction System (2017), 0 descendants of its own
- K170350: ToeMATE® Hammertoe Correction System (2017), 0 descendants of its own
- K151241: Synchro-Medical TIGER TRACK Screw System (2015), 0 descendants of its own

## 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/K130859
Methodology: https://510kreport.com/methodology