Mako Total Knee Application (3.0); Hybrid Tip Pointer

Mako Total Knee Application (3.0); Hybrid Tip Pointer is an FDA 510(k)-cleared medical device (K250608) manufactured by Mako Surgical Corp.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 24, 2025. Regulation: 8.