FDA Issues Proposed Rule to Classify Posterior Cervical Screw Systems

Today the FDA issued a proposed rule to classify posterior cervical screw systems. These systems are intended to immobilize and stabilize the cervical spine (neck) as part of spinal fusion surgery. The FDA believes there is enough information to establish special controls to help lessen known risks of the device, as outlined in the proposed rule. We believe that general and special controls provide a reasonable assurance of safety and effectiveness of these devices and are proposing to classify the devices into class II. This proposed rule does not apply to pedicle screw spinal systems, which are used in other spinal areas.

If the proposed rule becomes final, manufacturers without a cleared premarket submission (510(k)) will have to submit a 510(k) and demonstrate compliance with the special controls outlined in the rule. The FDA does not intend to require new 510(k)s, 510(k) amendments, or add-to-files for devices already on the market.

The proposed rule can be found by searching for docket number FDA-2015-N-3785 on www.regulations.gov. The comment period will be open for 90 days.

Thank you,

Food and Drug Administration
Center for Devices and Radiological Health