Universal Pilot Guidance Instrument System

The CTL Amedica Navigation Instrument System is intended to be used during the preparation and placement of CTL Amedica screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The CTL Amedica Navigation Instrument System is 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 vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

The CTL Amedica Navigation Instrument System is intended to be used during the preparation and placement of CTL Amedica screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open or minimally invasive procedures. The CTL Amedica Navigation Instrument System is 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 vertebra can be identified relative to a CT or MR based model, fluoroscopy images, or digitized landmarks for the anatomy.

The CTL Amedica Navigation Instrument System are manual surgical instruments for use with the Medtronic® StealthStation™ 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. This surgical imaging technology provides surgeons visualization for complex and MIS procedures and confirms the accuracy of advanced surgical procedures. Use of this navigation system provides the surgeon access to real-time, multi-plane 3D images (and 2D images) providing confirmation of hardware placement. The Navigation Instruments include the following: Drivers, Taps, Awls, Probes. Use of the Navigated Instrument System is limited to Taps ranging in sizes from 4.5mm to 8.5mm in diameter. The Navigation Instruments are to be used with the following CTL Amedica Systems but not limited to: RAPHAEL™ Pedicle Screw System Family, PICASSO II™ MIS Spinal System Family, TAURUS™ Pedicle Screw System Family. The CTL Amedica Navigation Instruments are designed for use only with the hardware and software of the Medtronic StealthStation Navigation System. The CTL Amedica Navigation Instruments are manufactured from Stainless Steel and Aluminum. All of these materials conform to ASTM F899.