DePuy Synthes announces 510(k) clearance for cement-augmented pedicle screw systems
DePuy Synthes announced it has received FDA 510(k) clearance for its Viper and Expedium fenestrated screw systems.
According to a company press release, the pedicle screws are intended to restore spinal column integrity when used with Confidence high viscosity spinal cement in patients with advanced spinal tumors. The screw systems can be used in either open or percutaneous spinal fusion surgery. According to the release, the fenestrated screws enable controlled cement delivery into the vertebra for immediate screw fixation.
“Metastatic disease in the spine can be severely painful and limiting for patients who are trying to maintain quality of life, and there is a significant need for spinal implants that enhance stability in metastatic bone disease so that these patients can continue to function freely,” William C. Horton, MD, vice president of Research & Development, DePuy Synthes Spine, said in the release. “We designed these fenestrated screw systems to help address those needs, and to facilitate minimally invasive solutions for patients suffering from this disease.”
DePuy Synthes expects both screw systems to be available in the United States later this year.