The FDA gave San Diego company NuVasive expanded 510 (k) clearance for the company’s Precice system, which treats patients with limb length discrepancy and deformities.
With the news, NuVasive is poised for further gains in the limb reconstruction and trauma markets, the company said in a news release.
Prior to the expanded FDA clearance, the Precice system was for limb lengthening of the femur and tibia. Now it’s OK’d for open and closed fracture fixation, pseudoarthrosis, malunions, nonunions and bone transport, a technique that allows for regeneration of bony tissue, typically used to treat bone loss due to trauma or infection.
The proprietary technology includes a complex internal gear system, which is remotely activated and controlled by magnets.