K2M received 510(k) clearance from the U.S. Food and Drug Administration to market the NILE Alternative Fixation Spinal System.
The system intends to provide stabilization between the spine and the rod, and to allow for reduction, translation, compression and distraction while sparing the anatomy. The system has also received the CE Mark.
The first surgical case using NILE in the United States was completed in March by Burt Yaszay, MD, a pediatric orthopedic surgeon, at Rady Children's Hospital in San Diego.