NuVasive Cleared Expanded 510(k) for Precice System

FDA has cleared a NuVasive 510(k) for an expanded use of its Precice system to now include open and closed fracture fixation, pseudoarthrosis, malunions, nonunions, and bone transport. Previously, the device was indicated for limb lengthening of the femur and tibia. The new clearance now covers bone transport of long bones in addition to limb lengthening. “Bone transport is a technique that allows for regeneration of bony tissue and is typically used to fill segmental bone loss due to trauma or infection, i.e. infected nonunions, segmental defect, and chronic bone infections,” the company says.

The system comprises an intramedullary device that once implanted utilizes an external remote controller to compress and distract long bones. It includes a “complex internal gear system remotely activated and controlled by permanent magnets,” the company says.