FDA Clears Nexxt Spine’s ALIF and Lateral Systems

Nexxt Spine LLC, a manufacturer of spinal surgery solutions, announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to its two lumbar-based systems; ALIF and lateral. This milestone will allow the company to commence in-house manufacturing of the two systems and plan for subsequent alpha launches in August and September, respectively.
 
Both systems will showcase the Nexxt Matrixx 3D printed titanium technology unique to the company. Recognized for sound science behind each interbody, Nexxt Spine has created the desired pore size and geometry that is now available in ALIF and Lateral.  Coupled with a modulus of elasticity lower than PEEK, microroughened surface technology and a 75 percent porous lattice there is no question Nexxt Spine is commanding industry attention.
 
“We are thrilled to be releasing these two powerhouses this year,” stated President Andy Elsbury. “Our engineering and 3D printing manufacturing teams has been working diligently to simultaneously develop and clear the two products after considerable surgeon demand for Nexxt Spine quality clinical outcomes for ALIF and lateral approaches.”
 
Forecasted summer launch dates are as follows: ALIF in August and lateral in September. An integrated plate system is expected to be launched for each product in the fourth quarter.
 
The FDA clearance follows the agency’s greelighting of the Nexxt Matrixx Corpectomy System earlier this spring. The company announced the first implantation of the Nexxt Matrixx Corpectomy System on April 3. Showcasing technology unique to the Nexxt Matrixx line of products, the corpectomy cage is an intentionally engineered 3D printed porous titanium implant.
 
The surgery was performed by Dr. Derek Taggard at Community Regional Medical Center in Fresno, Calif., on a trauma patient.
 
Dr. Taggard commented, “After much anticipation, I am very excited that the Nexxt Matrixx corpectomy implant is now available to the market. I am honored to have done the first live corpectomy implant. I believe this technology is the quickest path to successful arthrodesis for my patients. The spacious central cavity allows for a large amount of biologic and generous endplate contact; the porosity allows for lateral rapid in-growth as well.”
 
Dr. Taggard is recognized for his work as the director of Spinal and Neurotrauma at Community Regional Medical Center and as an associate professor of Neurosurgery at UCSF Fresno.