FDA Panel Recommends Pedicle Screws Be Reclassified

The Orthopaedic and Rehabilitation Devices Panel of the U.S. Food and Drug Administration’s (FDA) Medical Devices Advisory Committee has recommended that pedicle screw systems for the thoracolumbosacral spine be reclassified as 510(k) Class II devices. They are currently classified as Class III, requiring a pre-market approval in order to reach market.

Panel members considered screws used in the thoracic, lumbar and sacral spine as adjuncts to fusion for degenerative disc disease (DDD) and non-severe spondylolisthesis at L5-S1 (the base of the spine where it connects to the coccyx) and spondylolisthesis coupled with proven signs of neurologic impairment. The screw systems use longitudinal rods, spinal anchors such as screws, hooks or wires, and optional transverse connectors to stabilize single or multiple spinal motion segments from the upper thoracic spine to the sacrum for spinal fusion. They are made from materials including stainless steel, stainless steel alloys and unalloyed titanium.

“We, as a panel, determined that they were indeed safe and effective, although there was significant interest in pursuing further clinical data,” said John D. Kelly IV, M.D., panel chair. “With the special controls that a class II device would require, we thought [the devices were] safe and effective for public usage. The biggest reason was the indications for this device that had already been approved for Class II were far more risky and dangerous than the indications presented today, which were for DDD and low-grade spondylolisthesis. If the indications for fusion are present for those two conditions, we thought there were sufficient data to suggest that pedicle screw usage would enhance and ensure more predictable fusion.”

Class III devices are considered high-risk, which is why they have the most stringent requirements before being placed on the market. Devices in this class have to be proven safe and effective, and are not allowed to be proven safe by comparison with previous similar devices. Proof for class III devices must come from clinical trials. Minor device modifications, labeling changes and manufacturing changes must be reported, and the manufacturing company must provide an annual report for the device to the FDA.

Companies are allowed to use predicate devices already on the market to prove the safety and efficacy of Class II devices.

An FDA spokesperson indicated that the agency would issue a proposed order to reclassify these pedicle screws to Class II, hold a public comment period, and issue a final order to reclassify the device.