Vilex, LLC - FDA 510(k) Cleared Devices

Vilex, LLC is a dedicated lower extremity medical device company specializing in foot and ankle surgical solutions. Based in McMinnville, Tennessee, Vilex develops and markets an innovative portfolio of orthopedic implants and surgical systems designed by surgeons for surgeons.

The company has received 17 FDA 510(k) clearances from 17 total submissions since 2020. Vilex maintains a 100% clearance rate in the orthopedic device category, with its most recent FDA 510(k) clearance in 2026, demonstrating continued active development and regulatory engagement.

Vilex's product portfolio encompasses external fixation systems, total ankle replacement platforms, intramedullary nail systems, locking plating systems, compression staples, and minimally invasive surgical instruments. The company operates a Research and Education Center in Park City, Utah, and maintains a global distribution network of over 70 distributors and 250+ sales representatives.

Explore the complete list of Vilex FDA 510(k) cleared devices, including device names, product codes, and clearance dates in the database.

510(k) submissions have been managed by Telos Partners, LLC as regulatory consultant.