REAL INTELLIGENCE™ CORI™

REAL INTELLIGENCE CORI is a robotic-assisted orthopedic surgical navigation and burring system that uses passive infrared tracking to help surgeons plan and execute bone cuts during knee and hip replacement surgeries. It provides software-defined spatial boundaries for orientation and reference to anatomical structures, assisting in unicondylar knee replacement (UKR), total knee arthroplasty (TKA), revision knee arthroplasty, and total hip arthroplasty (THA) procedures.

CORI controls cutting engagement through two modes: exposure control (retracting the bur inside a guard if the surgeon approaches bone not to be cut) and speed control (limiting drill speed near target surfaces). The modifications to this version add a pre-operative planning screen allowing users to modify surgical plans before intraoperative workflow and a new widget to adjust cut planes during revision TKA procedures. The fundamental technology and safety mechanisms remain unchanged from the predicate.

Not stated in this summary. The document references ISO 13485 quality management standards and mentions design verification/validation testing and summative usability testing, but does not cite specific consensus standards like ISO, IEC, or ASTM for the device's functional performance.

CORI is substantially equivalent to predicate device K240139 because it maintains the same intended use, indications for use, and fundamental technological characteristics. The two software modifications (pre-operative planning screen and cut plane adjustment widget) do not impact system safety or effectiveness. Design verification, validation testing, and summative usability testing all demonstrated the device meets design requirements and is as safe and effective as the predicate in simulated surgical environments.