Vital Navigation System

Vital Navigation instruments are to be used during the preparation and placement of Vital and Vitality screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Vital Navigation instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

Vital Navigation instruments are to be used during the preparation and placement of Vital and Vitality screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. Vital Navigation instruments are specifically designed for use with the Medtronic StealthStation System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

The Vital Navigation System is comprised of nonsterile, reusable instruments including awls, probes, taps, and drivers that can be operated manually. These instruments are intended to be used with the Medtronic Synergy™ Experience StealthStation® System to assist surgeons in precisely locating anatomical structures in either open or minimally invasive procedures for preparation and placement of Vital and Vitality screws. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of these navigation systems provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement. Through the introduction of new styluses in this submission, the previously cleared Vital Navigation Taps and Reduction Driver (K191722) can be used with the existing Vital MIS PAT Handle (K203507) to allow the user to navigate while using the PAT or PASIT assembly. It is important to note that these styluses will not be navigated. As such, the toolcard for the NavLock taps or NavLock driver will not change with this new use scenario.