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RIGID PEDICLE BONE SCREW DOWNCLASSIFICATION TO CLASS II UNANIMOUSLY RECOMMENDED

This article was originally published in The Gray Sheet

Executive Summary

RIGID PEDICLE BONE SCREW DOWNCLASSIFICATION TO CLASS II UNANIMOUSLY RECOMMENDED for the treatment of degenerative spondylolisthesis and spinal fracture by FDA's Orthopedic and Rehabilitation Devices Advisory Panel at a July 22 meeting in Gaithersburg, Maryland. The recommendation, conditioned on the development of special controls for the devices, was based on data from a retrospective study presented at the meeting. Panel member Michael Mayor, MD, Dartmouth-Hitchcock Medical Center, Hanover, New Hampshire, stated that the study provided "more than enough data to give a downclassification recommendation to FDA."
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