ExactechGPS® System

The ExactechGPS® System is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. TKA Pro software application is specifically indicated for Total Knee Arthroplasty.

The ExactechGPS® System is intended for use during stereotaxic surgery to aid the surgeon in locating anatomical structures and aligning the endoprostheses with the anatomical structures. TKA Pro software application is specifically indicated for Total Knee Arthroplasty.

The ExactechGPS® System proposed in this submission is a modification of the ExactechGPS® System cleared per 510(k) #K193618. The ExactechGPS® System is an image-guided surgery, or navigation, system intended to be used during orthopedic surgical procedures to intraoperatively assist surgeons during arthroplasty. The ExactechGPS® System enables surgeons to acquire intraoperative data by computing and displaying information such as distances, angles, and placement of prosthetic components in order to identify and characterize bone cuts necessary to achieve surgical goals. The ExactechGPS® System works with ExactechGPS® hardware trackers that communicate intraoperative data to the ExactechGPS® hardware station to provide surgeons with real-time information on the positions of patient anatomical structures and instrumentation used to prepare bone during stereotaxic surgery. The proposed modifications do not change the ExactechGPS® System general intended use, general design features, or basic fundamental scientific technology.