RE: Classification of posterior cervical screws, including pedicle and lateral
mass screws [Docket No. FDA–2012–N–0001] FDA Orthopaedic and
Rehabilitation Devices Panel of the Medical Devices Advisory Committee
Dear Ms. Anderson:
The American Association of Neurological Surgeons (AANS), the Congress of Neurological Surgeons
(CNS), and the AANS/CNS Joint Section on Disorders of the Spine and Peripheral Nerves appreciate the
opportunity to provide comments to the Food and Drug Administration in advance of the meeting of the
Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Committee regarding the
classification of posterior cervical screws.
Currently, these screw devices are approved for use in the thoracic spine and are classified as a Class II
device. Their use in the posterior cervical spine is considered off-label, with respect to the products’
FDA-approval and labeling. Given the benefits to neurosurgical patients — due to the anatomical and
biomechanical advantages over current FDA approved techniques — the posterior cervical screws have
become the standard of care in managing trauma, degenerative disease, and deformity. We therefore
request that posterior cervical screws, including pedicle and lateral mass screws, remain FDA
Class II devices. Additionally, we recommend that the manufacturers provide data to the FDA for
on-label use of these screw devices in the posterior cervical spine.
…
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