# K221283: Hammertoe Truss System (HTS)

- Pathway: 510(k) (Traditional)
- Applicant: 4Web Medical, Inc.
- Decided: Sep 6, 2022 after 126 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: 11 generations back to K792022 (1979). 66 ancestors in all.
2 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)
- K190926: Hammertoe Truss System (HTS), 4Web, Inc. (2019) Summary page 4.

## Most influential descendants
- 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 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 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/K221283
Methodology: https://510kreport.com/methodology