AnyPlus Navigated Instruments System

The AnyPlus Navigated Instrument System is indicated for the preparation and placement of the Poly-Axial Screws of the AnyPlus Spinal Fixation System during a navigated thoracolumbar fusion procedure to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. This system is intended to be used in conjunction 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. The use of the AnyPlus Navigated Instrument system is limited to use only with the AnyPlus Spinal Fixation System.

The AnyPlus Navigated Instrument System is indicated for the preparation and placement of the Poly-Axial Screws of the AnyPlus Spinal Fixation System during a navigated thoracolumbar fusion procedure to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. This system is intended to be used in conjunction 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 vertebra, can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks of the anatomy. The use of the AnyPlus Navigated Instrument system is limited to use only with the AnyPlus Spinal Fixation System.

The AnyPlus Navigated Instrument system and the Primary Predicate: AnyPlus Spinal Fixation System (K091717), have identical material, the same technological characteristics, and the principle of operation (to implant an AnyPlus Screw). The Subject Device: AnyPlus Navigated Instruments, and the Additional Predicate: Navigated CD Horizon® Solera® Screwdrivers and Taps (K140454), have identical indications for use/intended use. Both the subject device and additional predicate's Taps and driver are intended to place the pedicle screws during the spinal surgery with the help of the Medtronic StealthStation® system. Both the subject device and additional predicate Taps and driver have equivalent critical lengths with a +/-0.15mm difference in tolerance. This minor difference between the subject device and the additional predicate instruments' critical length does not raise new questions of safety and effectiveness.