# K240035: TACTIX Vector Syndesmosis System

- Pathway: 510(k) (Traditional)
- Applicant: Vilex, LLC
- Decided: Aug 1, 2024 after 210 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: 10 generations back to K904436 (1990). 63 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201522: Arthrex Syndesmosis TightRope XP Buttress Plate Implant System, Arthrex, Inc. (2020) Summary page 4.
- K173278: ToggleLoc System, Biomet, Inc. (2018) Summary page 4.

## Most influential descendants
- K243408: TACTIX Vector Syndesmosis System (2024), 0 descendants of its own

## 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 TACTIC 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 B and C ankle fractures.

Source page: https://510kreport.com/device/K240035
Methodology: https://510kreport.com/methodology