RIWOtrack Navigation System

The RIWOtrack Navigation System is intended to continuously display the position and orientation of RIWOspine surgical instruments relative to the anatomy in medical image data in either open or minimal invasive orthopedic procedures. The use 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 the spine or pelvis, can be identified relative to images of the anatomy. This can include spinal procedures, where the target point for the procedure itself or for the access to the area of interest, is a rigid landmark, such as:
• Transforaminal procedure
• Interlaminar procedure

The RIWOtrack Navigation System is intended to continuously display the position and orientation of RIWOspine surgical instruments relative to the anatomy in medical image data in either open or minimal invasive orthopedic procedures. The use 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 the spine or pelvis, can be identified relative to images of the anatomy. This can include spinal procedures, where the target point for the procedure itself or for the access to the area of interest, is a rigid landmark, such as: • Transforaminal procedure • Interlaminar procedure.

The RIWOtrack Navigation System is an image-guided surgery system classified as Class II per 21 CFR 882.4560. It utilizes electromagnetic tracking to localize sensors attached to instruments within a defined electromagnetic field. The system includes an Intel-based PC and operates with x-ray (fluoroscopy) imaging modalities, providing AP and Lateral View, Video Input. The field generator is an NDI Navigation sensor Aurora mounted to an articulating metal arm. RIWOtrack instruments are tracked by electromagnetic sensors which can be attached to RIWOspine surgical instruments. The method of registration involves autodetection of x-ray markers of a reference device in intraoperative fluoroscopy images, achieving a mean system level accuracy with position error < 2mm and angular error < 2°.