SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS)

SixFix™ Hexapod Fixator and Deformity Analysis and Correction Software (DACS) is an FDA 510(k)-cleared medical device (K250472) manufactured by Amdt Holdings, 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 August 7, 2025. Regulation: 8.