Prime and DYNASTY® Additive Manufacturing Shells

Prime and DYNASTY® Additive Manufacturing Shells is an FDA 510(k)-cleared medical device (K202705) manufactured by Microport Orthopedics, 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 19, 2021. Regulation: 8.