Medtronic receives FDA 510(k) clearance for cement-augmented pedicle screws
Medtronic announced it has received FDA 510(k) clearance for its CD Horizon fenestrated screw set, which can be used in patients with advanced stage tumors involving the thoracic or lumbar spine. According to a company press release, this marks the first FDA clearance for cement-augmented pedicle screws.
The CD Horizon fenestrated screw set has cannulated pedicle screws with six holes near the end of the screw that reportedly allow for controlled cement injection into the vertebral body following screw placement. According to the release, the fenestrated screws are used with the company’s HV-R fenestrated screw cement, which is a polymethylmethacrylate cement. The continuous tract delivery system used for cement injection reportedly helps to reduce cement leakage at the adapter/screw interface and is compatible with minimally invasive surgery and open procedures.
“Palliative care is important for people with cancer, and Medtronic’s cement-augmented screws are a meaningful innovation that are designed to restore the integrity of the spinal column in patients with debilitating spinal tumors,” Doug King, senior vice president and president of Medtronic’s Spinal Division, which is part of the Restorative Therapies Group at Medtronic, said in the release. “The availability of our CD Horizon Fenestrated screw set represents an important advance for surgeons and provides them with another option for a complex procedure.”
According to the release, the CD Horizon fenestrated screw set is expected to be available this fall.