NuVasive has announced that it has received US Food and Drug Administration (FDA) 510(k) clearance for expanded indications of use for Attrax Putty with its thoracolumbar interbody portfolio for spine surgery.
Attrax Putty is a synthetic, bioactive and osteoconductive bone void filler designed to drive bone fusion. It features a surface microarchitecture which the company says provides an optimised environment for bone formation without added cells or growth factors.
Ryan Donahoe, chief technology officer at NuVasive, said: “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.
“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.
Robert Eastlack, an orthopaedic spine surgeon at Scripps Health (San Diego, USA) and board member of the San Diego Spine Foundation, added: “I’m excited to see the FDA recognising that the clinical results support the safe and effective use of these advanced implant combinations.
“In my practice and clinical research, patients treated with optimised 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.”