Medtronic Receives FDA 510(k) Clearance for Cement-Augmented Pedicle Screws
Medtronic received FDA 510(k) clearance to market the CD Horizon® Fenestrated Screw Set, indicated for treatment of advanced stage tumors in the thoracic and lumbar spine. This reportedly marks the first U.S. clearance for cement-augmented pedicle screws. The set will launch later this year.
The CD Horizon Fenestrated Screw Set is used with HV-R®, a PMMA-based cement, and are intended for use at spinal levels where the structural integrity of the spine is not severely compromised.
Source: Medtronic plc