FDA approves NavioPFS orthopedic surgical system (Blue Belt Technologies) for Knee Replacement
Blue Belt Technologies has received 510(k) clearance from the FDA to market its NavioPFS orthopedic surgical system. The clearance is for Unicondylar Knee Replacement, commonly known as partial Knee Replacement. The NavioPFS system incorporates technology to provide precision information to surgeons via smart instrumentation with robotic control. It delivers intra-operative navigation and 3D visualization during the surgery based on a seamless CT-free registration process. The company received CE Mark in February 2012 and has completed clinical studies since then in Belgium and the United Kingdom where the system has produced excellent early clinical results.
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