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The Neo ADVISE™ System is indicated to calculate the relative positions and distances between implanted Neo Pedicle Screw System™ screws, as estimated by visually identifying screw guides, to estimate rod length, visualize rod positioning, and create a rod template that can be used to visually guide the manually creation a contoured rod by the surgeon, with a mechanical rod bender. The Neo ADVISE™ System can be used in posterior open or percutaneous spine surgery in the thoracic, lumbar, and/or sacral spine when using the Neo Pedicle Screw System™.

The Neo ADVISE system is a tool that supports the surgeon in open and percutaneous spinal surgeries performed with the Neo Medical Pedicle Screw System (K222256). After the placement of the pedicle screws, the software scans the the screw head positions and shows them in Augmented Reality (AR) on an iPad. Based on the scanned screw positions, the software displays the distance between the screw heads and calculates the minimum rod length. The surgeon can select any of the pre-bent or straight rods of the Neo PSS and check the placement of the rod in the patient's body without touching the body or taking X-Ray images. The software calculates the distance between the screw head and the rod in the coronal and sagittal plane for the selected rod, indicating possible screw head adjustments. Again, based on the scanned screw position, the software can generate a custom bent rod template that follows the path through all screw heads. This provides the surgeon with a rod template that assists the surgeon in rod bending. The rod template is displayed in a 1-1 scale on the device in the sagittal and coronal plane, allowing the surgeon to copy the rod shape according to the template. The scanning of the screw heads can be performed using two distinct scanning methods, 3D scanning and Marker detection. 3D Scanning does not require any additional hardware. The surgeon scans each guide separately by overlaying the physical guide with a virtual guide in AR. 3D Scanning of the guides is limited to 10 guides. The Marker Detection scanning method allows the scanning of up to 20 guides. This is achieved by the use of the Neo Markers and the Neo Marker Base. The Neo Markers are attached to each guide, providing the software with a defined pattern, similar to QR codes, that can be recognized by the software. The Neo ADVISE System consists of several components. The software runs on an Apple iPad, which is put into a sterile bag to allow use in the sterile environment of the patient's area. The Neo Markers and the Neo Marker Base are needed to allow the scanning of the guides using the Marker Detection scanning method.