HyperFlex® Bunion Correction System

HyperFlex® Bunion Correction System is an FDA 510(k)-cleared medical device (K252997) manufactured by Hyperflex Medical. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 10, 2025. Regulation: 8.