SPINEART Navigation Instrument System

The SPINEART Navigation reusable instruments are intended to be used during the preparation and placement of SPINEART PERLA TL screws during thoracolumbar spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SPINEART Navigation reusable instruments are specifically designed for use with the eCential Op.n PERLA® TL Nay System. It is indicated for population with medical conditions requiring the placement of spinal screws and for which the use of stereotactic surgery may be considered to be appropriate and where reference to a rigid anatomical structure, such as a vertebra, can be identified. The guidance is based on an intra-operative surgical plan developed with Op.n PERLA® TL Nay Software and based on intraoperative 3D images provided by a compatible imaging system.

The SPINEART Navigation reusable instruments are intended to be used during the preparation and placement of SPINEART PERLA TL screws during thoracolumbar spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The SPINEART Navigation reusable instruments are specifically designed for use with the eCential Op.n PERLA® TL Nay System. It is indicated for population with medical conditions requiring the placement of spinal screws and for which the use of stereotactic surgery may be considered to be appropriate and where reference to a rigid anatomical structure, such as a vertebra, can be identified. The guidance is based on an intra-operative surgical plan developed with Op.n PERLA® TL Nay Software and based on intraoperative 3D images provided by a compatible imaging system.

The Spineart® Navigation reusable instruments are surgical instruments to be used with a Navigation System to assist surgeons in precisely locating anatomical structures in either open, minimally invasive, or percutaneous procedures for preparation and placement of pedicle screw system implants. Currently cleared Spineart® Navigation reusable instruments (K210472) feature a connecting area for the tracker compatible with the Navlock Tracker to be navigated with the Medtronic StealthStation® Navigation System. The purpose of this submission is to get clearance to include Spineart's eCential® Navigation Adapter (subject device) designed to enable navigation of Spineart Navigation Instruments with the eCential Op.n® Navigation System to the cleared range of SPINEART® Navigation Instrument System.