Vortex5 Tailor's Bunion Correction System

Vortex5 Tailor's Bunion Correction System is an FDA 510(k)-cleared medical device (K260291) manufactured by Nvision Biomedical Technologies, Inc.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 24, 2026. Regulation: 8.