Spine Elements announces FDA 510(k) clearance for expandable interbody fusion devices

Spine Elements announced it has received FDA 510(k) clearance to market its line of expandable interbody fusion devices.

The FDA clearance covers expandable interbody devices for posterior, anterior and lateral access to the lumbar spine. According to a company release, the lordotic angle can be increased during expansion with posteriorly placed and anteriorly placed devices and the coronal tilt can be changed during expansion with laterally placed devices. The devices will be made primarily with radiolucent polyetheretherketone material and Spine Elements’ Ti-Bond porous titanium coating.

“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,” Jason Blain, president and cofounder of Spinal Elements, said in the release. “While these expandable devices will work well with our conventional spine surgery platforms, we also believe they will complement our [minimally invasive surgery] MIS procedural options as well, as we look to increase our presence in posterior MIS solutions.”

According to the release, Spine Elements expects to begin clinical procedures with the devices later this year and expects an initial launch of the expandable devices in early 2017.

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