TACTIX Vector Syndesmosis System— 510(k) K243408

Name: FDA 510(k) clearance K243408
Creator: U.S. Food and Drug Administration
Published: 2024-11-27

Substantially Equivalent

Vilex, LLC

FDA 510(k) clearance K243408 for TACTIX Vector Syndesmosis System, Substantially Equivalent on 2024-11-27. Applicant: Vilex, LLC. Device class: 2.

Clearance details

Applicant: Vilex, LLC
Product code: Code HTN
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2024-11-01
Decision date: 2024-11-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Mcminnville, TN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code HTN

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K253115 — LARS ACJ2026-06-10
K252081 — SportLinc Syndesmosis Device2026-03-27
K253727 — Syndesmosis TightRope PRO2025-12-22
K251643 — Synchfix EVT2025-10-29
K251134 — RipCord2025-07-11

More clearances from Vilex, LLC

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K260900 — DYNEX® External Fixation Systems2026-04-17
K250304 — TITANEX Screw Systems2025-03-05
K240475 — Hintermann Series H2 Total Ankle System2024-12-02
K233816 — REDEMPTION Charcot Plating System2024-08-28
K240035 — TACTIX Vector Syndesmosis System2024-08-01

Adverse events under product code HTN

product code HTN

Injury: 310
Malfunction: 639
Total: 949

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.