Initia T3 Acetabular Hemispherical Shell System

Initia T3 Acetabular Hemispherical Shell System is an FDA 510(k)-cleared medical device (K242045) manufactured by Kyocera Medical 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 April 9, 2025. Regulation: 8.