Nuvasive today announced that its Attrax Putty received FDA 510(k) clearance for expanded indications in thoracolumbar interbody spine surgery.
Attrax Putty is a synthetic, bioactive and osteoconductive bone void filler that drives bone fusion. San Diego–based Nuvasive designed it with a surface microarchitecture that has an optimized environment for bone formation without added cells or growth factors.
A level I randomized controlled trial supports the bone grafting device as a bone graft substitute in posterolateral spinal fusions. In addition, recent studies demonstrated that Attrax Putty performs comparably to autograft bone in thoracolumbar interbody fusions, according to Nuvasive.
“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,” chief technology officer Ryan Donahoe said in a news release. “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.”
The expanded indication allows the company to use Attrax Putty with its procedurally integrated thoracolumbar interbody portfolio, including the Advanced Materials Science technologies of Modulus porous titanium and Cohere porous PEEK.
“I’m excited to see the FDA recognizing that the clinical results support the safe and effective use of these advanced implant combinations,” Robert Eastlack, an orthopedic spine surgeon at Scripps Health in San Diego, said. “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.”