TACTIX Vector Syndesmosis System
FDA 510(k)Class II (US FDA 510(k))
by Vilex, Inc.
Identifiers
- 510(k) Number
- K240035 FDA 510(k)
- FDA Product Code
- HTN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3030 FDA 510(k)
- Regulation Number
- 888.3030 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The TACTIX Vector Syndesmosis System is a knotless fixation device designed for syndesmosis repair, specifically addressing syndesmotic disruptions in Weber B and C ankle fractures. It employs adjustable, measurable tension to stabilize the distal tibiofibular joint during the healing process, ensuring proper alignment and fixation of the syndesmosis. This system is intended for orthopedic applications where secure fixation is critical to restoring ankle integrity following traumatic injury.
The device is supplied as a sterile, single-use orthopedic implant and is regulated under FDA 510(k) clearance (K240035) as a substantially equivalent traditional submission. It is intended for use in operating room settings by trained surgeons and requires proper handling and storage as per manufacturer guidelines. Compatibility with MRI is not specified, and the system is available in configurations tailored for syndesmosis fixation. No additional regulatory approvals beyond the stated 510(k) clearance are referenced in the available data.
Frequently asked questions
What is the TACTIX Vector Syndesmosis System used for?
The TACTIX Vector Syndesmosis System is designed specifically for syndesmosis repair in Weber B and C ankle fractures. It provides adjustable, measurable tension to stabilize the distal tibiofibular joint, ensuring proper alignment and fixation during the healing process. This is critical for restoring ankle integrity after traumatic injury, particularly in cases where secure fixation is required to prevent complications.
How is the TACTIX Vector Syndesmosis System supplied and is it reusable?
The system is supplied as a sterile, single-use orthopedic implant. It is intended for one-time use in an operating room setting by trained surgeons. Single-use design ensures sterility and reduces the risk of cross-contamination, which is essential for patient safety in surgical applications.
What configurations or sizes are available for the TACTIX Vector Syndesmosis System?
The TACTIX Vector Syndesmosis System is available in configurations tailored for syndesmosis fixation. While specific sizes or models are not detailed in the provided data, the system is designed to accommodate varying anatomical needs for distal tibiofibular joint stabilization. For precise sizing, refer to the manufacturer’s guidelines or product documentation.
How should the TACTIX Vector Syndesmosis System be stored?
The system must be stored according to the manufacturer’s instructions to maintain sterility and functionality. This typically includes keeping it in its original packaging, away from direct sunlight or extreme temperatures, and ensuring the sterile barrier remains intact until use. Proper storage is critical to prevent degradation and ensure the device performs as intended during surgery.
Is MRI compatibility specified for the TACTIX Vector Syndesmosis System?
The provided data does not specify MRI compatibility for the TACTIX Vector Syndesmosis System. If MRI imaging is required post-surgery, clinicians should consult the manufacturer’s guidelines or additional documentation to confirm whether the system is safe for MRI use. Always verify compatibility before scheduling MRI scans.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Tactix Vector | Vilex, Vilex, PDF Surgical Technique - cdn.prod.website-files.com, K240035 - TACTIX Vector Syndesmosis System | FDA 510 (k), TACTIX Vector Syndesmosis System — FDA K240035
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K240035 | Class II | Active |
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Manufacturer
- Manufacturer
- Vilex, Inc.
- FDA Applicant
- Vilex, LLC
Sources (1)
- FDA 510(k) K240035 24 fields · synced Oct 1, 2026