b-ONE MOBIO Total Knee System

b-ONE MOBIO Total Knee System is an FDA 510(k)-cleared medical device (K213673) manufactured by B-One Ortho, Corp.. This device is classified under the Orthopedic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 20, 2022. Regulation: 8.