Complete transcript is available at: http://www.fda.gov/ohrms/dockets/ac/cdrh06.html#orthopaedic
The Orthopaedic and Rehabilitation Devices Panel (the Panel) met on Friday, June 2, 2006 in Gaithersburg, MD.
The Panel made a recommendation to the Food and Drug Administration (FDA) on the RS Medical reclassification petition (Docket 2005P-0121) to reclassify the non-invasive bone growth stimulator from class III into Class II.
RS Medical proposed reclassification of the non-invasive bone growth stimulator intended for the treatment of an established nonunion acquired secondary to trauma and as an adjunct to lumbar spinal fusion surgery at 1 or 2 levels.
The device does not include invasive bone growth stimulators (Product code LOE) or ultrasonic non-invasive bone growth stimulators (Product code LPQ). The device is not intended for the treatment of congenital pseudoarthrosis or as an adjunct to cervical fusion surgery in patients at high risk for non-fusion.
RS Medical, the petition sponsor, presented a summary of the reclassification petition. A FDA reviewer presented the agency’s review of the proposed reclassification. A group of three manufacturers (The Bone Growth Stimulator Reclassification Opposition Group) and several public speakers presented their views regarding the proposed reclassification to the Panel. After deliberation on the 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 four to two to recommend that non-invasive bone growth stimulators are retained in class III.
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