US FDA downgrades class III pedicle screws to class II


The US Food and Drug Administration (FDA) has formally reclassified pedicle screws from class III to class II devices. The reclassification came into force on 30 December 2016.

Following a 2014 proposed order to reclassify the systems, the FDA began a two-year review process, receiving 15 public comments from individuals, and from groups including the Scoliosis Research Society (SRS), the North American Spine Society (NASS), and companies such as Medtronic and Invibio.

“The Scoliosis Research Society supports the recommendation… to down-classify rigid pedicle screw systems from class III to class II devices…the special controls as outlined in the Federal Register are adequate to ensure safety and efficacy of these devices,” the SRS comment reads. “It has become a well-accepted clinical standard among community and academic practitioners to utilise pedicle screws in this fashion. In fact it is unusual to not utilise pedicle screws.”

Similarly, Heidi Prather, then-president of NASS, wrote that the society “fully supports” the reclassification, commenting that, “NASS agrees with FDA that if properly manufactured and used, class II special controls, in addition to general controls, can be established to provide reasonable assurance of safety and effectiveness.”

According the FDA reclassification report, the organisation has also changed the name “pedicle screw spinal system” to “thoracolumbosacral pedicle screw system” to “clearly distinguish these devices from posterior cervical screw systems, which are not intended to be covered by the classification.”

Further to the general reclassification of rigid pedicle systems, the FDA also reclassified “dynamic stabilisation systems”, renaming the device subtype as “semi-rigid systems”. This follows claims from Invibio and Medtronic that rods made from PEEK should not be considered as dynamic stabilisation systems, “being technologically more similar to the rigid pedicle systems that will be defined as class II under the order,” according to Invibio. Medtronic similarly stated, “PEEK rods are not dynamic stabilisation systems and should not be classified as such.”

According to advice from SRS, “this action will decrease the regulatory burden associated with pedicle screws intended for rigid fixation. It will also allow greater opportunity for optimising instruction in their use.”