FDA Reclassifies Pedicle Screws

It’s official and completes a long regulatory, legal and scientific journey. Effective December 30, 2016, pedicle screw systems became classified as a Class II/special controls device by the FDA.

The agency is also renaming the device “thoracolumbosacral pedicle screw systems.”

Four years ago, after years of off-label use, the FDA’s orthopedic panel finally recommended that the FDA acknowledge what practitioners were already doing.

The devices are intended to treat degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1, or degenerative spondylolisthesis with objective evidence of neurologic impairment.

Pedicle screw spinal systems are one of the remaining pre-amendments Class III devices, which means that they were marketed prior to the Medical Device Amendments of 1976. FDA originally classified them as the highest-risk Class III, but to date they’ve been approved for the U.S. market via the less-stringent 510(k) premarket notification process.

FDA staff recommended the down-classification based on data provided by some 20 manufacturers in response to a 2009 FDA request for information that safety and effectiveness of pedicle screws can be assured through non-clinical testing, material composition, sterilization validation and labeling.

The agency published a proposed order to propose different classifications for rigid pedicle screw systems and semi-rigid systems (SRSs) in the Federal Register of November 12, 2014. Moreover, on May 22, 2013, the FDA held a classification meeting of the Orthopedic and Rehabilitation Devices Panel to discuss pedicle screw systems, which include rigid pedicle screw systems and SRSs. The agency received and has considered all the comments on the 2014 Proposed Order and met the legal requirements to reclassify the device.

Since the original 1998 classification, the agency wrote that changes in technological characteristics have occurred, “leading to the emergence of a new type of pedicle screw system, SRSs, previously referred to as dynamic stabilization systems (DSSs). SRSs are a subset of the pedicle screw systems. SRSs are defined as systems that contain one or more non-uniform and/or non-metallic longitudinal elements (e.g., polymer cords, moveable screw heads, springs) that allow more motion or flexibility (e.g., bending, rotation, translation) compared to rigid systems and do not provide immediate rigid fixation to the spinal column as an adjunct to spinal fusion procedures.”

This final classification puts to rest long legal battles resulting from the off-label uses of the screws that were originally only approved for use in the long bones of the arms and legs.