Spinal Elements receives FDA 510(k) clearance for expandable interbody device


Spinal Elements has received 510(k) clearance from the US Food and Drug Administration (FDA) to market a line of expandable interbody fusion devices. 

The clearance includes expandable interbody devices for posterior, anterior, and lateral access to the lumbar spine. The expandable interbody devices are designed to be placed in the intervertebral space of the spine at a collapsed height, and expand vertically to increase in height.

Additionally, the posteriorly-placed and anteriorly-placed devices are intended to increase in lordotic angle during expansion, and the laterally-placed devices can change coronal tilt during expansion.

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, medical director at The Spine Institute and professor of Surgery at Cidars-Sinai Medical Center in Los Angeles, USA, comments, “I am excited to get this device into a clinical setting, as 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 sagittal balance from a posterior approach unlike other devices I have experienced.”

The company plans to begin clinical procedures with the expandable devices later this year with an initial launch in early 2017.