Michael Barbella, Managing Editor02.21.23
NuVasive Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use of its Modulus Cervical interbody implant with a bone void filler, further enhancing the company's C360 portfolio.
"We believe that delivering differentiated procedural solutions that are clinically and economically advantageous is of paramount importance," NuVasive Chief Technology Officer Ryan Donahoe said. "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.
NuVasive Inc. develops spinal technologies via less-invasive, procedurally integrated surgical solutions that aim to deliver reproducible and clinically proven outcomes. The company's 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. A $3.1 billion merger deal with Globus Medical is pending.
Reference
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.
"We believe that delivering differentiated procedural solutions that are clinically and economically advantageous is of paramount importance," NuVasive Chief Technology Officer Ryan Donahoe said. "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.
NuVasive Inc. develops spinal technologies via less-invasive, procedurally integrated surgical solutions that aim to deliver reproducible and clinically proven outcomes. The company's 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. A $3.1 billion merger deal with Globus Medical is pending.
Reference
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.