# K190926: Hammertoe Truss System (HTS)

- Pathway: 510(k) (Traditional)
- Applicant: 4Web, Inc.
- Decided: Jul 23, 2019 after 105 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: 10 generations back to K792022 (1979). 65 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160264: Additive Orthopaedics Hammertoe Correction System, Additive Orthopaedics, LLC (2016) Summary page 4.
- K151838: PRO-TOE Hammertoe Fixation System, Wrightmedicaltechnologyinc (2015) Summary page 4.

## Most influential descendants
- 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 Hammertoe Truss System (HTS) is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants in the Hammertoe Truss System (HTS) can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).

Source page: https://510kreport.com/device/K190926
Methodology: https://510kreport.com/methodology