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The Bolt Navigation System assists in the accurate placement of pedicle screws when used in conjunction with an intraoperative fluoroscope. It utilizes intraoperative fluoroscopic and pre- operative MRI or CT axial images to provide surgical planning and navigational telemetry relative to gravity, based on a fixed entry point ascertained by the user and validated by intraoperative fluoroscopic imaging. It is not intended to track patient position. The System is indicated for open and minimally invasive pedicle screw placement using a posterior approach in the thoracolumbar and sacral spine (T-9 to S1) where the patients' relevant rigid anatomical structures can be clearly identified on the imaging.

The BNS is comprised of the Bolt Navigation Unit (BNU) (an iPod touch® mobile digital device with the Bolt navigation software loaded on it), the Bolt single use case, and sterile drape. The BNS is intended to provide navigational guidance during spine surgery. The system uses preand perioperative imaging data, and input from the surgeon via the BNU touchscreen to construct the proper angular position of the instrumentation and implants relative to gravity, and communicates this information to the surgeon via the BNU screen attached to the instrument allowing the surgeon to look at both the surgical site and the navigation data at the same time, thus attenuating the risk of attention shift. The BNS provides guidance data by displaying the angular orientation of a surgical instrument (such as a pedicle probe or awl) relative to a surgeon selected entry point on the patient and gravity. Angular orientation of the instruments is linked to the imaging data via the BNS. The system is intended to be used for both image fusion and navigation for spine surgery applications where reference to relevant rigid structures can be identified relative to a perioperative image data of the anatomy and the gravity vector.