This article is more than 5 years old. Information may no longer be current.

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

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

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.

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