Real Intelligence™ CORI™

REAL INTELLIGENCE CORI (CORI) is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. CORI is indicated for use in surgical procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. These procedures include:
• unicondylar knee replacement (UKR),
• total knee arthroplasty (TKA),
• revision knee arthroplasty, and
• total hip arthroplasty (THA).
CORI is intended to be used by trained medical professionals in a hospital or clinical setting equivalent to an orthopedic surgery suite.

REAL INTELLIGENCE CORI (CORI) is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. CORI is indicated for use in surgical procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined. These procedures include: unicondylar knee replacement (UKR), total knee arthroplasty (TKA), revision knee arthroplasty, and total hip arthroplasty (THA).

The subject of this Traditional 510(k) is REAL INTELLIGENCE CORI (CORI), a robotic-assisted orthopedic surgical navigation and burring system. CORI uses established technologies of navigation via a passive infrared tracking camera. For knee applications, CORI aids the surgeon in planning the surgical implant location and in executing the surgical plan by controlling the cutting engagement of the surgical bur. For knee applications, CORI software controls the cutting engagement of the surgical bur based on its proximity to the planned target surface. The cutting control is achieved with two modes: Exposure control adjusts the bur's exposure with respect to a guard. If the surgeon encroaches on a portion of bone that is not to be cut, the robotic system retracts the bur inside the guard, disabling cutting. Speed control regulates the signal going to the tool control unit itself and limits the speed of the drill if the target surface is approached. Alternatively, the surgeon can disable both controls and operate the robotic drill as a standard navigated surgical drill.