Blue Belt’s Navio surgical system gets FDA marketing approval

17 July 2014 (Last Updated July 17th, 2014 18:30)

The US Food and Drug Administration (FDA) has granted marketing approval for Blue Belt Technologies' Navio surgical system, patellofemoral joint (PFJ) replacement surgery.

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The US Food and Drug Administration (FDA) has granted marketing approval for Blue Belt Technologies' Navio surgical system, patellofemoral joint (PFJ) replacement surgery.

The PFJ application expands the system's indications from unicondylar knee replacement to provide the full suite of partial knee replacement options.

According to the company, the addition of PFJ replacement allows its customers to provide robotics-assisted surgery to patients who may be suffering from early to mid-stage osteoarthritis and choose partial knee replacement as an alternative to total knee replacement.

Blue Belt Technologies president and CEO Eric Timko said: "We are pleased to announce this major milestone in the continued success and evolution of our Navio platform.

"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 surgical system, which is notable for its open implant architecture, uses a CT-free, robotics-assisted approach for its partial knee replacement applications.

"Smith and Nephew's Journey PFJ patellofemoral joint system will be the first implant system available for use with the Navio patellofemoral joint system application."

Blue Belt said that Smith and Nephew's Journey PFJ patellofemoral joint system will be the first implant system available for use with the Navio patellofemoral joint system application.

The company develops next-generation 'smart' surgical instruments for initial use in orthopedic procedures and then for other surgical specialties including neurosurgery, spinal and otolaryngology (ENT).

The Navio surgical system includes patented technology to provide precise robotic control to surgeons via an intelligent, handheld, computer-assisted bone cutting tool.

The system offers the surgeon increased safety and improved accuracy while performing bone shaping tasks through minimal incisions.

Earlier this month, Blue Belt signed an agreement with Smith & Nephew to support their Journey UNI knee system on Blue Belt's Navio Surgical System, which has an open-implant architecture that allows users to select a number of different manufacturers' implants.


Image: The Navio handpiece assists the surgeon in precision bone preparation. Photo: courtesy of Business Wire.