REAL INTELLIGENCE™ CORI™ XT (CORI XT)

REAL INTELLIGENCE CORI XT is a robotic orthopedic surgical navigation and burring system that assists surgeons in planning and executing surgical implant placement by controlling the cutting engagement of a surgical bur. It uses passive infrared tracking and intraoperative software to create software-defined spatial boundaries for orientation and reference to anatomical structures during knee and shoulder arthroplasty procedures.

CORI XT employs the same fundamental technologies as its primary predicate (CORI K240139): passive infrared tracking camera navigation, intraoperative software-controlled bur cutting with two modes (exposure control and speed control), and automatic bur retraction or speed limitation when the surgeon approaches protected bone. The device maintains identical technological characteristics to the predicate while extending support to shoulder arthroplasty procedures.

Software verification per IEC 62304 (Medical device software lifecycle); biocompatibility per BS EN ISO 10993-1; safety and EMC testing per IEC 60601-1 and IEC 60601-1-2; usability engineering per IEC 62366-1:2015+A1:2020; and accuracy and usability validation testing through sawbone and cadaver models.

CORI XT is substantially equivalent because it has the same intended use and fundamental scientific technology as the primary predicate CORI (K240139) and shares shoulder arthroplasty indication alignment with secondary predicate ExactechGPS (K213546). Comparative cut-to-plan accuracy testing demonstrates equivalent implant placement accuracy to both predicates, and usability testing confirms representative users can safely and effectively operate the device in simulated surgical environments.