The Food and Drug Administration (FDA) has cleared the Navio PFS system, made by Blue Belt Technologies, Inc., for performing unicondylar knee replacement (UHR) surgeries. Company officials say the system aims to provide improved control to surgeons when they are shaving the bone tissue in preparation for placement of an implant. Blue Belt is located in Pittsburgh, Pennsylvania.
The NavioPFS consists of a 3D camera, a visualization system, and a handheld resurfacing device that provides real-time robotic control of the tip in a manner that is similar to a CAD/CAM. The system received European approval in February 2012 and the device has since been used in surgeries in Belgium and the UK.
Blue Belt literature describes the NavioPFS™ surgical system as a device that packs advanced robotic technology into a handheld form. The PFS hand-piece embodies multiple intelligent control algorithms that allow the surgeon to precisely resurface bone based on a predefined plan. The navigation system, which tracks real-time position of the hand-piece, allows only the targeted bone to be removed while the robotics enforces a safety zone.
