Blue Belt Technologies announced another major regulatory win with FDA clearance for its Stride unicondylar knee device, designed to be paired with the company’s U.S.-approved NavioPFS orthopedic implantation system.
The win bolsters Pittsburgh, Pa.-based Blue Belt’s portfolio of robotic products designed to replace manual instruments used for knee surgery. The Stride unicondylar knee is an implant designed to treat medial and lateral compartment osteoarthritis, and Blue Belt expects to begin marketing the device in the U.S. right away.
Blue Belt will sell Stride alongside its existing NavioPFS, which was cleared in 2012. Together, the devices use 3D visualization and computer navigation to guide hand-held instruments during bone resurfacing and implants knee surgeries.
"We are excited to be able to offer the Stride implant on our NavioPFS surgical system. Our design team, led by Dr. Jess Lonner, focused on optimizing the Stride implant to integrate seamlessly with the NavioPFS system," Eric Timko, CEO, said in prepared remarks.
Mako recently won an injunction against Blue Belt Technologies and ex-Mako sales vice president Jeff Gellman, ending a breach of contract lawsuit between the robotic surgery companies.