November 1995 AAOS Report

FDA proposes reclassifying use of pedicle screws

The U.S. Food and Drug Administration (FDA) published a proposed rule in the Federal Register on Oct. 4 that would reclassify the use of the bone screw in the pedicle from class III to class II, when used for the treatment of degenerative spondylolisthesis and spinal trauma. This recommendation is based on the reports of the Orthopaedic and Rehabilitation Devices Panel. The FDA also is proposing, on its own initiative, to expand the intended uses of the device to include pedicle screw spinal systems intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities and deformities, including spondylolisthesis, fractures and dislocations, scoliosis, kyphosis, and spinal tumors. This proposed rule is open to public comment until Jan. 2, 1996. Comments received in response to this proposed rule, along with other relevant information that the agency may obtain, will be relied upon by the agency in developing a final regulation. The Academy will be submitting formal comments to the FDA in support of the proposed rule. In addition, individuals can send comments directly to the Dockets Management Branch (HFA-305), FDA, Room 1-23, 12420 Parklawn Dr., Rockville, Md. 20857.

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