SAN DIEGO, Feb. 21, 2023 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced that it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the use of its Modulus Cervical interbody implant with a bone void filler, further enhancing the Company’s C360 portfolio. The expanded indications deliver new value in the cervical segment to surgeons and hospitals.
“We believe that delivering differentiated procedural solutions that are clinically and economically advantageous is of paramount importance,” said Ryan Donahoe, chief technology officer at NuVasive. “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.”
Attrax Putty is the first synthetic bone graft substitute to receive FDA cleared Indications for Use in thoracolumbar interbody fusion spacers in December 2021. Subsequently published evidence clinically validated the combination of NuVasive’s Advanced Materials Science solutions, Modulus XLIF and Attrax Putty, as having clinical and economic advantages over traditional, non-porous interbody implants and premium-priced biologics.1
“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.
1. Malone H, Mundis GM, Collier M, et al. A novel approach to evaluating lateral lumbar interbody fusion using a 3D-Printed Porous Titanium Interbody Device. 27th International Meeting on Advanced Spine Techniques. Online. July-August 2020.
About NuVasive
NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, with a mission to transform surgery, advance care, and change lives. The Company’s less-invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. The Company’s comprehensive procedural portfolio includes surgical access instruments, spinal implants, fixation systems, biologics, software for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative neuromonitoring technology and service offerings. With more than $1 billion in net sales, NuVasive operates in more than 50 countries serving surgeons, hospitals, and patients. For more information, please visit www.nuvasive.com.
Forward-Looking Statements
NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons and hospitals, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products, the Company’s ability to adequately manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.
SOURCE NuVasive, Inc.