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NuVasive receives expanded FDA 510(k) clearance for magnetic, limb lengthening system
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The FDA has granted NuVasive expanded 510(k) clearance for the Precice system from NuVasive Specialized Orthopedics. The expanded indications now include open and closed fracture fixation, treatment for pseudarthrosis, malunions and nonunions, and bone transport.
According to a company press release, prior to the expanded clearance, the Precice system was indicated for limb lengthening of the femur and tibia. In addition to limb lengthening, the system is now indicated for bone transport of long bones, which allows for regeneration of bony tissue and is used to fill segmental bone loss due to trauma or infection.
The PRECICE system platform consists of an intramedullary (IM) device that, once implanted, uses an external remote controller to noninvasively compress and distract long bones. The key to the platform is magnetic interaction between the Precice IM nail and an external remote control.
“This FDA 510(k) clearance of Precice for expanded indications, including bone transport, demonstrates the evolving innovative capabilities of our technology to transform and expand the limb reconstruction and trauma markets,” Massimo Calafiore, president of NuVasive Specialized Orthopedics (NSO), said in the press release. “NSO remains committed to providing trauma surgeons with proper solutions to treat unmet clinical needs and challenging fractures.”
Reference:
www.nuvasive.com