DePuy Synthes Receives FDA Clearance for Cement-Augmented Pedicle Screws

By Julie A. Vetalice

DePuy Synthes received FDA 510(k) clearance to market VIPER® and EXPEDIUM® Fenestrated Screw Systems for use with cement to restore spinal column integrity in the treatment of advanced stage tumors. The screws may be used in open or percutaneous spinal fusion. Launch is slated for mid-2017.

A cannulated design along with fenestrations above the screw tip support controlled delivery of CONFIDENCE™ High Viscosity Spinal Cement into the vertebra, providing immediate fixation.

Source: DePuy Synthes

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory