Blue Belt Technologies Earns FDA Clearance for New Navio Surgical Application

Minneapolis, Minn.-based Blue Belt Technologies has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market their latest surgical application for the Navio surgical system, patellofemoral joint (PFJ) replacement surgery. The PFJ application expands the Navio surgical system’s indications from unicondylar knee replacement to offer the full suite of partial knee replacement options.

The addition of patellofemoral joint replacement enables Blue Belt customers to offer robotics-assisted surgery to a greater population of patients who may be suffering from early to mid-stage osteoarthritis and choose partial knee replacement as an alternative to total knee replacement.

“We are pleased to announce this major milestone in the continued success and evolution of our Navio platform,” said Eric Timko, president and CEO of Blue Belt Technologies. “We focus our technology development efforts on clinically relevant applications that can benefit from reproducible precision. Adding patellofemoral replacement was the logical next step for us. This PFJ application will continue to arm our surgeon customers with the next-generation in robotics-assisted tools to safely and effectively treat a greater population of patients.”

The Navio surgical system uses a CT- (computed tomography-) free, robotics-assisted approach for its partial knee replacement applications, and is notable for its open implant architecture. Smith and Nephew’s patellofemoral joint system, Journey PFJ, will be the first implant system available for use with the Navio PFJ application.

Blue Belt Technologies makes smart surgical instruments for initial use in orthopedic procedures and then for other surgical specialties including neurosurgery, spinal and otolaryngology.