Neurosurgery Supports FDA Action on Facet Screws and Bone Growth Stimulators
On Sept. 8, the FDA’s Center for Devices and Radiological Health’s Orthopaedic and Rehabilitation Devices Panel met to consider the classification of facet spinal screws, from the unclassified pre-amendments device type to the Class II device designation. The panel also considered reclassifying non-invasive bone growth stimulator devices from the Class III designation to Class II. AANS/CNS Drugs and Devices Committee chair, William C. Welch, MD, FAANS, presented comments supporting the Class II designation for facet screws. AANS/CNS Drugs and Devices Committee member, Charles A. Sansur, MD, FAANS, offered comments supporting the Class II designation for bone growth stimulator devices. Following the discussion, the panel agreed to recommend the Class II designation for both devices. Class II devices are typically cleared through the less onerous 510(k) process.