REAL INTELLIGENCE™ CORI™ XT (CORI XT)

REAL INTELLIGENCE CORI XT (CORI XT) is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. REAL INTELLIGENCE 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,
• anatomic total shoulder arthroplasty (aTSA), and
• reverse total shoulder arthroplasty (rTSA)
• total hip arthroplasty (THA).

REAL INTELLIGENCE CORI XT (CORI XT) is intended to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. REAL INTELLIGENCE 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.

The subject of this Traditional 510(k) is REAL INTELLIGENCE CORI XT (CORI XT), a robotic orthopedic surgical navigation and burring system. Like its predecessor, REAL INTELLIGENCE CORI (K240139), CORI XT uses established technologies of navigation via a passive infrared tracking camera. CORI XT aids the surgeon in planning the surgical implant location and in executing the surgical plan by controlling the cutting engagement of the surgical bur. CORI XT intraoperative 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. Speed control regulates the signal going to the motor control module. When the surgeon encroaches on a portion of bone that is not to be cut per the surgeon's plan, the robotic system will disable cutting by retracting the bur inside the guard or by limiting the speed of the drill. Alternatively, the surgeon can disable both cutting controls and operate the robotic drill as a standard navigated surgical drill.