Klassic Knee System-Sombrero Patella

Klassic Knee System-Sombrero Patella is an FDA 510(k)-cleared medical device (K150105) manufactured by Total Joint 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 February 16, 2015. Regulation: 8.