TaperSet™ Hip System

TaperSet™ Hip System is an FDA 510(k)-cleared medical device (K252846) manufactured by Shalby Advanced Technologies, Inc. Dba Consensus Orthopedics. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 19, 2025. Regulation: 8.