Blue Belt Technologies has announced it has received FDA clearance for a new orthopedic surgical system, according to a news release.
The initial clearance of the NavioPFS surgical system is for unicondylar knee replacement surgery.
"We could not be any more excited to gain FDA clearance of our NavioPFS system," said Mr. Eric B. Timko, president and CEO of Blue Belt Technologies, in the release. "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 said it is continuing to develop other applications where the system can be used to perform precision bone shaping procedures.
Blue Belt Technologies, a technology company focused on commercializing a precision robotic solution for orthopedic surgery, is headquartered in Pittsburgh, Pa.
Related Articles on FDA Clearances:
LENSAR Cataract Laser System Receives FDA Clearance for Corneal Incisions
Merit Medical Receives FDA Clearance for the Endovascular Snare System
Ethicon Receives FDA Clearance for Sealant Patch