ZIMMER BIOMET INC 230H3002 The Tether™

MAXIO V2 is a stereotactic accessory intended for the spatial positioning and orientation of an instrument guide to assist in manual advancement of one or more instruments for image guided procedures. It provides Preoperative planning and intra operative guidance to the surgeon by visually representing the targeted path and position(s) on the image based model of the target organ along with the data provided by the instrument manufacturer.

The device is intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging of the human body and provides measurements of shear wave speed and tissue stiffness, ultrasound tissue brightness parameters such as ultrasound beam attenuation and backscattering coefficient, and estimates of speed of sound, in internal structures of the body. The device is intended to be used by trained healthcare professionals, in a healthcare environment.The device is indicated for imaging of anatomical structures in the abdomen and measurements of physical properties in the liver and the spleen.In particular, the device is intended to provide:Linear distance measurements of anatomical structures,Measurement of shear wave speed at selected shear wave frequencies, and estimates of tissue stiffness in the liver and the spleen,Estimates of ultrasound tissue brightness parameters in the liver at selected ultrasound frequencies,Measurement of brightness ratio between structures and in particular between the liver and the kidney,Estimates of speed of sound in the liver.The shear wave speed measurements, ultrasound tissue brightness parameters, elastic properties estimates, brightness ratio may be used as an aid to the diagnosis, monitoring and clinical management of adult and pediatric patients with liver disease.