Blue Belt Tech. Receives FDA Clearance

The company's initial clearance of the NavioPFS in the United States is for partial knee replacements.

December 11, 2012
Manufacturing Group
Assembly Materials Devices/Implants/Equipment Quality/Metrology People/Facilities

Blue Belt Technologies Inc., an innovative medical technology company focused on commercializing a precision robotic solution for orthopedic surgery, has received 510(k) clearance from the FDA to market its NavioPFS orthopedic surgical system.

The company's initial clearance in the United States is for Unicondylar Knee Replacement (UKR) which is commonly known as partial knee replacement. A partial knee replacement is surgery that may replace the osteoarthritic portion of the inside (medial) and/or outside (lateral) compartment of the knee with an implant prosthesis. The majority of partial knee replacement surgeries are currently performed using manual instruments which can be inconsistent and lead to high revision and retreatment rates.

Blue Belt's NavioPFS system incorporates patented technology to provide precision to surgeons via smart instrumentation with robotic control. The NavioPFS delivers intra-operative navigation and 3D visualization during the surgery based on a seamless CT-free registration process.

The company's NavioPFS, for use in UKR surgery, received CE Mark in February 2012 and the Company has completed clinical casework since then in Belgium and the United Kingdom where the system has produced excellent early clinical results.

Eric B. Timko, president and CEO of Blue Belt Technologies says, "We could not be any more excited to gain FDA clearance of our NavioPFS system. 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. We are confident that NavioPFS accomplishes these goals, and provides excellent results for patients."

The company will commence commercialization in the United States immediately for the UKR application and is continuing to develop other applications where the system can be utilized to perform precision bone shaping procedures.