Fusion Robotic Navigation System

The Fusion Robotic Navigation System is indicated for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures in reference to rigid patient anatomy and fiducials that can be identified on a 3D imaging scan. The Fusion Robotic Navigation System is indicated for assisting the surgeon in placing pedicle screws in vertebrae in the posterior lumbar region (L1-S1). The system is designed for lumbar pedicle screw placement with the patient in the prone position and is compatible with the ATEC Invictus® Spinal Fixation System.

The Fusion Robotic Navigation System is indicated for use as an aid for precisely locating anatomical structures and for the spatial positioning and orientation of a tool holder or guide tube to be used by surgeons for navigating and/or guiding compatible surgical instruments in open or percutaneous spinal procedures in reference to rigid patient anatomy and fiducials that can be identified on a 3D imaging scan. The Fusion Robotic Navigation System is indicated for assisting the surgeon in placing pedicle screws in vertebrae in the posterior lumbar region (L1-S1). The system is designed for lumbar pedicle screw placement with the patient in the prone position and is compatible with the ATEC Invictus® Spinal Fixation System.

The proposed Fusion Robotic Navigation System is considered substantially equivalent to the REMI Robotic Navigation System (K223070). The only change to the indications for use is the replacement of Accelus LineSider with ATEC Invictus® Spinal Fixation System. The IFU is also updated with the addition of the Invictus Guide Tube, Invictus 8mm Guide Tube Sleeve and Invictus MIS Driver. The principles of operation, mode of operation, and performance are the same as the predicate. To facilitate the use of the ATEC Invictus® Spinal Fixation System with the Fusion Robotic Navigation System three additional instruments were added: the Invictus Guide Tube (P1012), Invictus 8mm Guide Tube Sleeve (P1021), and Invictus MIS Screwdriver (P1067). All of these instruments are manufactured from the same materials used in the predicate system and also follow the same manufacturing processes.