FDA reclassifies pedicle screw systems from class III to class II devices

Issue: February 2017

The FDA has reclassified pedicle screw systems from a preamendments class III device to a class II device with special controls, effective Dec. 30, 2016.

Perspective from Todd J. Albert, MD

The final order was issued by the FDA after it re-evaluated data that pertained to pedicle screw systems.

In November 2014, the FDA proposed reclassification of pedicle screw spinal systems to distinguish the rigid pedicle screw systems from the semi-rigid pedicle screw systems.

Under the final order, pedicle screw systems were also renamed as “thoracolumbosacral pedicle screw systems.” The pedicle screw systems were renamed to delineate the devices from the posterior cervical screw systems, which are not going to be covered by that section of the order.

With the Dec. 30 order, dynamic stabilization systems — a subtype of pedicle screw systems regulated under product code NQP — were also reclassified into class II devices with special controls and were renamed “semi-rigid systems.” The FDA finalized the reclassification of rigid pedicle screws systems and revised the classification of the semi-rigid systems when the devices are intended for mobilization and stabilization of segments in the thoracic, lumbar and sacral spine as an addition to fusion for treatment of degenerative disc disease and spondylolisthesis at L5-S1 or degenerative spondylolisthesis in cases with neurological impairment.

According to the final order, a semi-rigid system that was marketed before the reclassification needs to submit an amendment to its previously cleared premarket 510(k) notification to demonstrate compliance with the special controls. This compliance with the special controls for semi-rigid pedicle screw systems will not be enforced until June 28, 2018.

Pedicle screw systems were first classified in 1998. The Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee met on May 22, 2013 to discuss the classification of rigid pedicle screw systems. ‒ by Monica Jaramillo

Reference:

www.gpo.gov

Perspective

Todd J. Albert, MD

The most recent reclassification of thoracolumbosacral screws to Class II devices is another important step for spinal surgeons treating patients who may require use of these devices. Although surgeons will generally use what they feel is needed and best for the patients, this change (as was the change for cervical lateral mass fixation) allows a broadening of appropriate teaching and promotion that allows most appropriate use. We must also remember that we, as surgeons, bear the responsibility to use the tools in the most appropriate manner for patients and help define which disease processes and indications are best suited for the devices.

Todd J. Albert, MD

Spine Surgery Today Editorial Board member

Disclosures: Albert reports he receives royalties from DePuy Synthes and Zimmer Biomet on cervical and thoracolumbar devices. He is president elect of the Scoliosis Research Society.