FDA approves Nexxt Spine’s 3D printed Stand Alone Cervical System
Indiana-based medical device manufacturer Nexxt Spine has announced that its NEXXT MATRIXX Stand Alone Cervical System has been approved by the FDA, receiving FDA 510(k) clearance. The spinal solution is a stand-alone anterior cervical interbody fusion system manufactured using GE Additive’s Mlab 100R metal 3D printer.
Made from titanium, the recently approved NEXXT MATRIXX Stand Alone Cervical System is designed help treat degenerative disc disease in mature patients, functioning as an adjunct to fusion at one of two contiguous levels. The small but innovative spinal device comes with a built-in screw system and needs no other fixation inside the body.
The spinal solution adds to the company’s growing NEXXT MATRIXX brand, which now offers a range of 3D printed titanium spinal devices. The devices developed by the company are known for combining surface topography, cellular scaffolding and bone biology to fit seamlessly into the body and promote bone integration. The new system is available in a range of sizes to best fit the patient and comes with a number of drill and inserter options.
“This enhancement of the NEXXT MATRIXX portfolio was the next natural progression for Nexxt Spine,” commented Andy Elsbury, President of the company. “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.”
Earlier this year, Nexxt Spine invested in two additional GE Additive Concept Laser Mlab 100R 3D printers, bringing its total capacity to five machines. Though a relatively recent adopter of AM—Nexxt Spine started using 3D printing two years ago—the company has gone all in, scaling up its spinal implant production significantly with the 3D printers.
