Spinal Elements Receives FDA Clearance

A line of expandable interbody fusion devices, made by Spinal Elements, Inc., has received 510(k) clearance from the U.S. Food and Drug Administration. This clearance includes devices for posterior, anterior, and lateral access to the lumbar spine. The expandable devices are placed in the intervertebral space of the spine at a collapsed height and expanded vertically to increase in height. The posteriorly placed and anteriorly placed devices can increase in lordotic angle during expansion, and the laterally placed devices can change the side-to-side tilt during expansion.

According to the news release, the expandable devices will be made primarily from radiolucent PEEK material and feature Spinal Elements’ Ti-Bond® porous titanium coating at the endplate contacting surfaces.

Hyun Bae, M.D., medical director at The Spine Institute and professor of Surgery at Cedars-Sinai Medical Center, Los Angeles, commented, “I believe the application of the device will help me address the needs of my patients. The ability of the device to expand as well as increase lordosis post-implantation will help me achieve saggital balance from a posterior approach unlike other devices I’ve experienced.”

Jason Blain, president and co-founder of Spinal Elements, added, “We believe the market for expandable interbody devices will continue to grow and the devices that were cleared will allow us to continue to grow our portfolio of proprietary solutions for our customers. Spinal Elements plans to begin clinical procedures with the expandable devices later this year with an initial launch in early 2017.