Spinal Elements Gains FDA Clearance of Lucent XP-Curved Expandable TLIF

By Julie A. Vetalice

Spinal Elements Gains FDA Clearance of Lucent XP-Curved Expandable TLIF

Spinal Elements was granted FDA clearance to market the Lucent® XP-Curved Expandable Interbody. Lucent XP-Curved is the third platform in the Lucent XP line of expandable devices, and the fifth expandable device within the company's MIS Ultra™ suite of products and procedures. Launch is expected within coming months.

The device and its instrumentation allow for steerable placement of the intervertebral implant, followed by expansion of the implant’s height once surgically placed.

The device will be offered in three lengths, with multiple lordotic options of up to 15° to assist surgeons in restoring normal spinal alignment and balance during open or MIS TLIF approaches. Devices in the Lucent XP family are made primarily of PEEK and feature Ti-Bond®, a hydrophilic porous titanium coating with nano-scale surface features.

“With the recently announced acquisition of [Benvenue's] Orbit discectomy technology and the introduction of new expandable platforms such as Lucent XP-Curved, Spinal Elements is able to provide an increasing number of comprehensive solutions to our spine surgeon customers,” said Jason Blain, President and CEO.

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory