FDA WARNING_LETTER - Spinal Elements, Inc - January 15, 2014

On June 12, 2014, the FDA issued a Warning Letter to Spinal Elements, Inc. following an inspection from January 6-15, 2014. The inspection revealed that the firm's Lucent and Lucent Ti-Bond Intervertebral Body Fusion Devices were adulterated and misbranded.

The devices were found to be adulterated under section 501(f)(1)(B) of the Act because the firm lacked an approved premarket approval (PMA) application or an investigational device exemption. They were also misbranded under section 502(o) for failure to notify the FDA of intent to introduce the devices into commercial distribution via a 510(k) submission.

Specifically, the firm made major design changes to the Lucent and Lucent Ti-Bond devices, including adding a "bulleted" design, new sizes (10x27mm & 10x32mm), and a 5-degree lordosis angle to certain sizes (10x22mm, 10x27mm, 10x32mm & 12x27mm). These changes significantly affect safety and effectiveness and require a new 510(k).

Furthermore, the devices were adulterated and misbranded due to unsubstantiated claims in labeling and on the website regarding the Ti-Bond coating. Claims such as "