NuVasive Inc. (NSDQ:NUVA) said today it won expanded FDA 510(k) clearance for tis Precice magnetic limb lengthening system, now cleared to include open and closed fracture fixation, psuedoarthrosis, malunions, nonunions and bone transport.
The San Diego, Calif.-based company’s Precice system is designed to treat patients with limb length discrepancy, limb deformities and chronic nonunions and consists of an intermedullary device that is implanted and can be remotely controlled to compress and distract long bones.
The device operates around magnetic interaction between the intramedullary nail and an external remote control and features a complex internal gear system that is remotely activated and controlled by permanent magnets, NuVasive said.
“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. 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,” Nuvasive Specialized Orthopedics prez Massimo Calafiore said in a press release.
Prior to the expansion, the device was cleared for limb lengthening of the femur and tibia, the company said.
Earlier this week, NuVasive leveled a lawsuit against former CEO Patrick Miles, who jumped ship for Alphatec (NSDQ:ATEC) earlier this month, alleging that he enacted a year-long scheme to secretly back Alphatec while discouraging NuVasive from acquiring the smaller company.