# The FDA Reclassification of Cervical Pedicle and Lateral Mass Screws: A Case Study in Regulatory History

## TL;DR

This paper examines how cervical spine screws were reclassified by the FDA after a 35-year delay, highlighting the collaboration between medical professionals and regulatory bodies.

## Contribution

The paper provides a detailed case study of the FDA reclassification process for cervical pedicle and lateral mass screws, emphasizing lessons for future regulatory decisions.

## Key findings

- The reclassification of cervical pedicle and lateral mass screws took 35 years due to legal challenges and lack of outcome data.
- Off-label use of thoracolumbar screws helped generate the data needed for reclassification.
- Collaboration between physicians and professional organizations was crucial in the reclassification process.

## Abstract

The classification of medical devices by the Food and Drug Administration (FDA) involves rigorous scrutiny from specialized panels that designate devices as Class I, II, or III depending on their levels of relative risk to patient health. Posterior rigid pedicle screw systems were first classified by the FDA in 1984 and have since revolutionized the treatment of many spine pathologies. Despite this early classification by the FDA, posterior cervical pedicle and lateral mass screws were not reclassified from unclassified to Class III and then to Class II until 2019, nearly 35 years after their initial classification. This reclassification process involved a decades-long interplay between the FDA, formal panels, manufacturers, academic leaders, practicing physicians, and patients. It was delayed by lawsuits and a paucity of data demonstrating the ability to improve outcomes for cervical spinal pathologies. The off-label use of thoracolumbar pedicle screw rigid fixation systems by early adopters assisted manufacturers and professional organizations in providing the necessary data for the reclassification process. This case study highlights the collaboration between physicians and professional organizations in facilitating FDA reclassification and underscores changes to the current classification process that could avoid the prolonged dichotomy between common medical practice and FDA guidelines.