Blue Belt Gets FDA Nod for Technology to Treat UKRs
Blue Belt Technologies Inc. has received 510(k) clearance from the U.S. Food and Drug Administration to market its NavioPFS orthopedic surgical system. The system is cleared to perform unicondylar knee replacements (UKRs), often simply known as partial knee replacements.
A partial knee replacement is surgery to 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 currently are performed using manual instruments that can, according to Blue Belt, be inconsistent and lead to high revision and retreatment rates.
The NavioPFS system incorporates smart instrumentation with robotic control designed to allow surgeons better precision. The system also delivers intra-operative navigation and 3D visualization during the surgery based on a computed tomography-free registration process.
NavioPFS received CE marking for use in UKR surgeries from European regulators in February this year. The company has completed clinical casework since then in Belgium and the United Kingdom where the system has produced positive early clinical results.
“We could not be any more excited to gain FDA clearance of our NavioPFS system,” said Eric B. Timko, president and CEO of Blue Belt Technologies. “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.”
Company officials said Blue Belt will start selling in the United States immediately for the UKR application, and the firm continues to develop other applications where the system can be used to perform precision bone-shaping procedures.
Based in Pittsburgh, Pa., Blue Belt Technologies develops smart surgical instruments with precision robotics for use in orthopedic procedures. Company officials hope to expand beyond the orthopedic market.