FDA is proposing to classify posterior cervical screw systems into Class II (special controls) and to continue to require premarket notification for the devices.
A posterior cervical screw system is a prescription device used to provide immobilization and stabilization in the cervical spine as an adjunct to spinal fusion. The term “posterior cervical screw system” is used to distinguish these devices from currently-classified pedicle screws cleared for use in other spinal regions.
FDA's panel supports this recommendation because special controls plus general controls would provide reasonable assurance of the safety and effectiveness of the device. The risks to health for this device type are known, and can be adequately mitigated by special controls (e.g., mechanical testing, biocompatibility and labeling).
FDA will accept comments through June 8, 2016.
Source: FDA, federalregister.gov
Click here to review the regulatory history of the posterior cervical screw system.