# K160264: Additive Orthopaedics Hammertoe Correction System

- Pathway: 510(k) (Traditional)
- Applicant: Additive Orthopaedics, LLC
- Decided: Jun 1, 2016 after 120 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: 9 generations back to K792022 (1979). 50 ancestors in all.
4 later devices descend from it; 1 cites it directly.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050259: Arthrex Bio-Pin, Arthrex, Inc. (2005) Summary page 4.
- K141420: Fastforward, MedShape, Inc. (2014) Summary page 4.
- K133477: Toegrip, Implant for Proximal Inter-Phalangeal Arthrodesis, Synchro Medical (2014) Summary page 4.

## Most influential descendants
- K190926: Hammertoe Truss System (HTS) (2019), 3 descendants of its own
- K221283: Hammertoe Truss System (HTS) (2022), 2 descendants of its own
- K231453: SnapHammer Hammertoe Correction System (2024), 1 descendant of its own
- K250613: SnapHammer Hammertoe Correction System (2025), 0 descendants of its own

## Indications for use
The Additive Orthopaedics Hammertoe Correction System is indicated for fixation of fractures, and fusion of small bones in the foot and hand; where such fragments are not under tension or load-bearing.

Source page: https://510kreport.com/device/K160264
Methodology: https://510kreport.com/methodology