Medical Devices; Orthopedic Devices; Classification of Posterior Cervical Screw Systems

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to classify posterior cervical screw systems into class II (special controls) and to continue to require a premarket notification (510(k)) to provide a reasonable assurance of safety and effectiveness of the device. A posterior cervical screw system is a device used to provide immobilization and stabilization in the cervical spine as an adjunct to spinal fusion surgery. The term "posterior cervical screw systems" is used to distinguish these devices from currently classified thoracolumbosacral pedicle screw systems for use in other spinal regions.