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FDA proposes new classification of posterior cervical screw systems
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The FDA recently proposed to classify posterior cervical screw systems into class II, referred to as special controls, and to continue to require premarket notification in an effort to allow for reasonable assurance for the safety and effectiveness of these devices.
According to information from an FDA release, if the classification is approved then it will help establish special controls to lessen known risks of the device. The proposed rule does not apply to pedicle screw spinal systems, however, which are used in other spinal areas.
According to the official classification docket, the FDA is proposing posterior cervical screw systems be classified into class II as an adjunct to fusion for several acute and chronic instabilities of the cervical spine and craniocervical junction. Among these instabilities are traumatic spinal fractures and/or traumatic dislocations, instability or deformity, failed previous fusions, tumors involving the cervical spine, degenerative disc disease and others.
If the proposed rule is approved, manufacturers without a cleared premarket submission will have to submit a 510(k) application and demonstrate compliance with the new special controls.
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