The US Food and Drug Administration (FDA) has granted 510(k) approval to Blue Belt Technologies' orthopedic surgical system for use in Unicondylar Knee Replacement (UKR) procedures.
Using the company’s patented technology, the CE-marked NavioPFS system replaces the osteoarthritic portion with an implant prosthesis and provides precision to surgeons via smart instrumentation with robotic control.
Based on a seamless CT-free registration process, the system also delivers intra-operative navigation and 3D visualization during the surgery.
Studies conducted on NavioPFS system in Belgium and the UK have shown excellent early clinical results, claims the company.
Blue Belt Technologies president and CEO Eric Timko said, "The entire Blue Belt team, including our physician advisors, has remained committed to providing orthopedic surgeons and hospitals a more precise and consistent technique to perform UKR procedures that takes into consideration the current economic environment in our healthcare system."
In addition to the use in UKR applications, the company is planning to utilize NavioPFS system in precision bone shaping procedures.