The Orthopaedic and Rehabilitation Devices Panel (the Panel) met on Thursday, December 11, 2003 in Gaithersburg, MD to make a recommendation to the Food and Drug Administration (FDA) on the FDA-proposed reclassification of the intervertebral body fusion device (cage) intended for spinal fusion procedures in skeletally mature adults with degenerative disc disease (DDD) at one or two levels from C2-C7 and L2-S1 using autogenous bone graft. The device does not include combination products, such as the intervertebral body fusion device using morphogenic proteins and scaffolds.
A FDA reviewer presented the agency’s reclassification proposal. A manufacturer’s association, a spine surgeon, and a manufacturer presented their views regarding the proposed reclassification to the Panel. After deliberation on the industry and FDA presentations and the background material FDA provided, the Panel considered FDA’s questions. The Panel then completed the reclassification questionnaire and summary data sheet.
The Panel then voted unanimously to recommend that FDA reclassify the device into class II. The Panel recommended three special controls to control to reasonably assure the safety and effectiveness of the device: 1) a guidance document, that may include clinical data for designs and materials beyond those currently approved, 2) device tracking (for all implants not just cages) for a limited period of time, and 3) testing guidelines, including fracture toughness, potential and response to wear particulates, and device retrieval analysis for a limited number of explanted devices.
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