NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced the Company received U.S. Food and Drug Administration (FDA) 510(k) clearance for expanded indications of use for Attrax® Putty with its comprehensive thoracolumbar interbody portfolio for spine surgery.
Attrax Putty is the first synthetic biologic to receive indications for use in interbody fusions of the thoracolumbar spine.
“The expanded indications of Attrax Putty with thoracolumbar implants support the clinical efficacy of Attrax Putty and highlight the comparative clinical advantage over competitive biologic offerings in the market,” said Ryan Donahoe, chief technology officer at NuVasive. “This first and only 510(k) clearance of its kind demonstrates NuVasive’s commitment to advancing the standard of spine care—while delivering enhanced economic value to our customers.”
With this clearance, Attrax Putty can now be used with NuVasive’s procedurally integrated thoracolumbar interbody portfolio that includes the Advanced Materials Science™ (AMS) technologies of Modulus® porous titanium and Cohere® Porous PEEK™. These AMS implants are rooted in three key principles of surface, structure, and imaging and designed to enhance the osseointegration and biomechanical properties of implant materials.4,5
“I’m excited to see the FDA recognizing that the clinical results support the safe and effective use of these advanced implant combinations,” said Robert Eastlack, MD, orthopedic spine surgeon at Scripps Health in San Diego and board member of the San Diego Spine Foundation. “In my practice and clinical research, patients treated with optimized porous titanium cages like Modulus XLIF in combination with Attrax Putty have shown notable radiographic and clinical success. This implant combination for spinal fusion has driven cost-savings at my institution while continuing to provide clinical value for my patients.”