Pedicle-Screw Fixation in the Lumbar Spine.

This article provides a perspective on the development of pedicle-screw fixation in the lumbar spine, the biomechanics of its application, the possible complications, and the scientific evidence that supports specific applications in selected disorders. The overall goal is to objectify the debate currently surrounding the use of these devices. Lumbar-pedicle fixation devices are currently considered class III med-ical devices. According to the Food and Drug Administration, such devices are investigational or experimental, have not been proved safe and effective, and may potentially pose a risk to patients.