August 1998 AAOS Report

FDA reclassifies pedicle screw to class II device

The Food and Drug Administration (FDA) has issued a final rule reclassifying pedicle screw spinal systems to class II from class III for certain indications. The final rule, published in the Federal Register July 27, 1998, states that sufficient information exists to demonstrate the safety and effectiveness of pedicle screw spinal systems intended to provide immobilization and stabilization of spinal systems in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudarthrosis). The reclassification specifically does not include spinal systems intended for use in the cervical spine or in pediatric populations. The full text can be found at www.gpo.gov.

In 1994, the FDA Advisory Panel on Orthopaedic and Rehabilitative Devices recommended the classification change after an indepth review and meta-analysis of the literature; review of publicly-released investigational device exemption data from patients treated with pedicle screws; and consideration of a cohort study of patients treated with the device which found pedicle screw fixation to be as safe and effective for degenerative spondylolisthesis and spinal fractures as other means of achieving spinal fusion, and in some respects clearly superior.

"The Academy is pleased that a final rule has been issued reclassifying the pedicle screw spinal systems to class II for specific purposes," said William W. Tipton Jr., MD, Academy executive vice president. "It ends years of confusion about a treatment that many orthopaedic surgeons believe is effective and in the best interest of patients with appropriate indications."

In related action, the medical societies have been granted summary judgments in five cases in four jurisdictions with five different judges in the pedicle screw litigation; there have been no cases where the court considered summary judgment for the medical societies and denied it. As a result, the Plaintiffs Legal Committee has dropped at least one lawsuit against the medical societies with prejudice (the case cannot be appealed or retried).


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