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FDA clears orthopedic surgical system for UKR

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Blue Belt Technologies Inc. received 510(k) clearance from the FDA to market its NavioPFS orthopedic surgical system for unicondylar knee replacement.

According to a company press release, the NavioPFS system incorporates patented technology to provide precision to surgeons via smart instrumentation with robotic control. During the surgery, the system delivers intra-operative navigation and 3-D visualization based on a CT-free registration process.

"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 [unicondylar knee replacement] UKR procedures that takes into consideration the current economic environment in our health care system. We are confident that NavioPFS accomplishes these goals, and provides excellent results for patients,” Eric B. Timko, president and chief executive officer of Blue Belt Technologies, stated in the release.