NuVasive (Nasdaq:NUVA) announced today that it received FDA 510(k) clearance for use of its Modulus Cervical interbody implant with a bone void filler.
The expanded indication creates new offerings in the cervical segment to surgeons and hospitals. It also further enhances the company’s C360 portfolio, according to a news release.
“We believe that delivering differentiated procedural solutions that are clinically and economically advantageous is of paramount importance,” said Ryan Donahoe, NuVasive CTO. “This clearance represents a significant milestone towards that goal, expanding our advanced materials combination of Modulus and Attrax Putty to our cervical interbody within the C360 portfolio.”
NuVasive’s Attrax Putty received FDA clearance for use in thoracolumbar interbody fusion spacers last year. In doing so, it became the first synthetic bone graft substitute to receive such clearance.
Subsequently published evidence clinically validated the combination of NuVasive’s Modulus XLIF and Attrax Putty. The evidence demonstrate clinical and economic advances over traditional, non-porous interbody implants and premium-priced biologics.
“When planning my interbody fusion cases, knowing that both the implant and the biological environment are participating in fusion gives me confidence for the longer constructs I usually perform in my practice,” said Chris Shaffrey, Duke Health University.