FDA grants 510(k) clearance for Nexxt Spine’s Matrixx system

5 October 2017 (Last Updated October 19th, 2017 11:28)

The US Food and Drug Administration (FDA) has granted 510(k) clearance for medical device manufacturer Nexxt Spine to market its Nexxt Matrixx system of 3D-printed porous titanium.

FDA grants 510(k) clearance for Nexxt Spine’s Matrixx system
Image: Nexxt Matrixx System Interbody and VBR. Photo: courtesy of Business Wire.

The US Food and Drug Administration (FDA) has granted 510(k) clearance for medical device manufacturer Nexxt Spine to market its Nexxt Matrixx system of 3D-printed porous titanium.

The new system uses next-generation technology to create interbody and vertebral body replacement (VBR) devices with optimised open architectural porosity, residue-free surface technology, and robust radiographic imaging performance.

According to several studies, textured titanium alloy surfaces produce a positive bone response, including an increase in osteoblast differentiation and surface osteointegration as compared to classically smooth surfaces.

Based on the studies, the company has combined its residue-free, surface technology with an open, varied porosity, titanium architecture.

The Nexxt Matrixx implants exhibit up to four times more surface area for bone apposition and up to two times more open pore volume than conventional spinal implants.

Nexxt Spine president Andy Elsbury said: “The Nexxt Matrixx System applies breakthrough technology to our company’s product portfolio and surgeon response has been overwhelmingly positive.

“The Nexxt Matrixx implants exhibit up to four times more surface area for bone apposition and up to two times more open pore volume than conventional spinal implants.”

“We will continue to expand our Nexxt Matrixx offering throughout 2017 and into 2018 to ensure this differentiated technology is available for all spinal fusion surgical approaches.”

The company noted that the first products to feature the Nexxt Matrixx technology are available in both interbody and VBR options in an assortment of height, length, width, and lordotic angulation combinations.

These products are designed to accommodate the unique anatomic and clinical circumstances of each patient.

Nexxt Spine is focused on designing, manufacturing and distributing new spinal solutions.