VySpine Announces FDA Clearance for VyPlate Anterior Cervical Plate System
Wednesday, August 17, 2022
VySpine, a spine innovation leader using differentiated materials and designs, announced today that it has received 510(k) clearance from the FDA for its VyPlate Anterior Cervical Plate System. The VyPlate ACP system is indicated for stabilization of the anterior cervical spine from C2 to C7, employing unicortical screw fixation at the anterior face of the vertebral bodies.
The VyPlate ACP System features plates and screws manufactured from titanium alloy as specified by ASTM F-136. The system’s robust yet simple locking mechanism ensures that the bone screws are fully captured within the VyPlate.
“The VyPlate ACP System is a unique, elegantly simple system,” said Tom McLeer, CEO of VySpine. “It offers a great deal of versatility and flexibility while providing ease of use for the surgeon. The VyPlate is intuitive while also being robust and adaptable.”
The VyPlate ACP System is offered in numerous sizes, ranging from single level to five level plates. The VyPlate’s bone screws can either be variable (with a high degree of angulation), or in a fixed angle to the plate. Additionally, the VyPlate bone screws are available in self-drilling or self-tapping configurations. The screws come in a range of lengths and diameters to provide optimal fit with patient anatomy.