# K243408: TACTIX Vector Syndesmosis System

- Pathway: 510(k) (Special)
- Applicant: Vilex, LLC
- Decided: Nov 27, 2024 after 26 days
- Product code: HTN (Washer, Bolt Nut)
- Device class: 2
- Regulation: 21 CFR 888.3030
- 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 K904436 (1990). 64 ancestors in all.
No later device cites it as a predicate yet.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240035: TACTIX Vector Syndesmosis System, Vilex, LLC (2024) Summary page 5.

## Indications for use
The TACTIX Vector Syndesmosis System is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting. Specifically, the TACTIX Vector Syndesmosis System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis (syndesmosis disruptions) in connection with Weber Band C ankle fractures.

Source page: https://510kreport.com/device/K243408
Methodology: https://510kreport.com/methodology