FDA Ortho Panel to Consider Pedicle Screw Reclassification

The FDA's Orthopaedic and Rehabilitation Devices Panel is meeting on September 21, 2012 to discuss and make recommendations about classification of posterior cervical screws.

Posterior pedicle cervical screws are currently allowed on the market through the 510(k) clearance process.

Also included are pedicle and lateral mass screws. Cervical pedicle and lateral mass screws are components of rigid, posterior spinal screw and rod systems generally intended as an adjunct to fusion for the treatment of degenerative disc disease (as defined by neck pain confirmed by radiographic studies), trauma, deformity, failed previous fusion, tumor, infection, and inflammatory disorders in the cervical spine.

There are three FDA regulatory classifications of medical devices: Class I, Class II and Class III. The classifications are assigned by the risk the medical device presents to the patient and the level of regulatory control the FDA determines is needed to legally market the device. As the classification level increases, the risk to the patient and FDA regulatory control increase.

The North American Spine Society supports the reclassification petition submitted by the Orthopedic Surgical Manufacturers’ Association (OSMA) on November 22, 2011 to classify pedicle and lateral mass screws for cervical spine use from unclassified status to Class II.

To read OSMA's reclassification petition, click here.

The meeting will be held at the Hilton Washington DC North, Gaithersburg, Maryland.

The public is invited to present data, information, or views, orally or in writing. Written submissions may be made to the contact person listed below on or before September 14, 2012. Oral presentations from the public will be scheduled between approximately 12:15 p.m. and 1:15 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before September 6, 2012.

The contact person is: Sara J. Anderson, Food and Drug Administration, Center for Devices and Radiological Health, 10903 New Hampshire Ave., Bldg 66, rm. 1611, Silver Spring, Maryland 20993-0002. Her phone number is (301) 796-7047.