FDA Expands 510(k) Clearance for NuVasive’s Limb Lengthening Platform to Include Bone Transport

Novel magnetic implantable technology cleared to treat fractures and orthopedic indications.

Integrated medical device manufacturer NuVasive, Inc. a company focused on introducing less-invasive surgical solutions to orthopedics, released the FDA has granted expanded 510(k) clearance to the company’s PRECISE® system, which remotely controls the compression and distraction of long bones, to include new indications including bone transport.

Originally approved to treat patients with limb-length discrepancies, deformities and chronic nonunions, Indications for the platform, administered intramedullary and developed by the company’s specialized orthopedics NOS division, now include open and closed fracture fixation, pseudoarthrosis, malunions, nonunions and to effectively support bone transport.

The company said that prior to the expanded FDA clearance, its PRECISE system was primarily indicated to lengthen femurs and tibias, but is now indicated for bone transport, a technique that supports the regeneration of bony tissue and can be used to fill segmental bone loss due to trauma or infection.

According to the company, the key element of the PRECISE platform is its magnetic interaction between the device’s intramedullary nail and its external control. It features a complex internal gear system that is activated remotely and controlled by permanent magnets. “This advancement in limb reconstruction allows for a precision controlled distraction phase with the ability to non-invasively customize treatment,” said NuVasive.

"This FDA 510(k) clearance of PRECICE for expanded indications … demonstrates the evolving innovative capabilities of our technology to transform and expand the limb reconstruction and trauma markets,” said Massimo Calafiore, President of NuVasive’s NSO division. “NSO remains committed to providing trauma surgeons with proper solutions to treat unmet clinical needs and challenging fractures. This allows us to treat more patients suffering from debilitating segmental bone defects through the use of PRECICE in bone transport procedures," he added.

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PRECICE® system from NuVasive Specialized Orthopedics™ (NSO) 

Guy Tiene

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