HipGuide (V 1.0.0.0)

HipGuide (V 1.0.0.0) is an FDA 510(k)-cleared medical device (K260321) manufactured by Orthopedic Driven Imaging, LLC. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 7, 2026. Regulation: 8.