DYNAMIS™ Implant System

DYNAMIS™ Implant System is an FDA 510(k)-cleared medical device (K251075) manufactured by Promethean Restorative, LLC. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 24, 2025. Regulation: 8.