Nexxt Spine
Nexxt Spine FDA
Nexxt Spine's NEXXT MATRIXX FDA 510 (k) cleared Stand Alone Cervical System device.
Nexxt Spine has received FDA clearance of its 3D printed NEXXT MATRIXX Stand Alone Cervical System.
This stand-alone cervical interbody fusion system is the latest addition to the NEXXT MATRIXX portfolio and has been made available for pre-order to current distributor partners. Like the rest of the NEXXT MATRIXX series, the Stand Alone Cervical System has been additively manufactured with GE Additive’s Concept Laser Mlab technology. With FDA 510 (k) clearance, the device is adjudged to be at least as safe and effective as products already on the market.
The Stand Alone Cervical System is designed to be used as an adjunct to fusion at one or two contiguous levels when treating skeletally mature patients for degenerative disc disease. It is being introduced to market by Nexxt Spine with ‘eager anticipation’. The company increased its investment in additive manufacturing earlier this year and believes its products are benefitting from a marriage of design expertise and quality manufacturing, ‘mastering the trifecta’ of surface topology, cellular scaffolding and bone biology relevance within the Stand Alone Cervical System.
When expanding its fleet of GE Additive Concept Laser machines to five in April, the company remarked how it had been able to accelerate product development, making a ‘seamless jump’ from R&D to serial production. The launch to market of the Stand Alone Cervical System is further proof of that.
“This enhancement of the NEXXT MATRIXX portfolio was the next natural progression for Nexxt Spine,” commented company President Andy Elsbury. “With patient care always top of mind, we strive to develop end products that surgeons prefer, and hardware patients can count on. Our Stand Alone Cervical is no exception and will showcase the propensity of NEXXT MATRIXX technology to facilitate the body’s natural power of cellular healing for fortified fusion.”
