DePuy Synthes Spine (now part of J&J) received FDA clearance to offer its EXPEDIUM, VIPER, and VIPER 2 pedicle screw systems for treatment of adolescent idiopathic scoliosis (AIS).
The devices already had clearance to be used on adults with scoliosis.
From DePuy:
The EXPEDIUM technology was first introduced in 2004. The VIPER and VIPER2 Spine Systems have been used in minimally invasive spine surgery for a wide range of pathologies since 2005 and 2008, respectively.
The new indication, which was received last month, clears the way for the devices to be used in posterior non-cervical pedicle screw fixation in adolescent patients and for the company to provide training and education about its appropriate use.
Press release: DEPUY SYNTHES SPINE RECEIVES 510(k) CLEARANCE FOR USE OF EXPEDIUM® AND VIPER® SPINE SYSTEMS FOR ADOLESCENT IDIOPATHIC SCOLIOSIS (AIS)…
