FDA Clears NuVasive’s Cervical Interbody Implant System

NuVasive Inc. a medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, announced U.S. Food and Drug Administration (FDA) 510(k) clearance of the CoRoent Small Interbody System indicated for intervertebral body fusion at multiple contiguous levels in the cervical spine. This marks the first U.S. clearance for a cervical cage to be used at up to four contiguous levels.
 
Cervical radiculopathy and myelopathy secondary to cervical degenerative discs are common diagnoses in adult patients and have been shown to cause significant disability and loss of productivity.¹ As a result of this common condition, more than 200,000 cervical surgical procedures are performed in the U.S. per year.²
 
“This FDA 510(k) clearance is another key milestone for NuVasive as we continue to deliver new innovation to the spine market. The ability to treat multi-level cervical disc degeneration in patients displaying cervical radiculopathy and myelopathy is a meaningful advancement for spine surgeons,” said Jason Hannon, NuVasive’s president and chief operating officer. “This first and only clearance is an example of NuVasive’s commitment to defining the components necessary to properly address an unmet clinical need and expand our presence and competitive positioning in the cervical market.”
 
The NuVasive CoRoent Small Interbody System is an interbody cage manufactured from PEEK-Optima that provides stabilization of the spinal motion segment while fusion takes place. A hollow core allows for packing of autogenous and/or allogeneic bone graft comprised of cancellous, cortical, and/or corticocancellous bone graft material to help promote a solid fusion. Rows of teeth on the surface of each end of the device serve to grip the adjacent vertebrae to resist migration and expulsion of the device. The device includes marker pins composed of titanium alloy or tantalum.
 
The implants included in the CoRoent Small Interbody System clearance are CoRoent Small (S), CoRoent Small Lordotic (SL), CoRoent Small Lordotic Plus (SLP), CoRoent Small Hyperlordotic (SHL), and CoRoent Small Contoured (SC).
 
References
¹Grasso G: Clinical and radiological features of hybrid surgery in multilevel cervical degenerative disease. Eur Spine J 2015;24(Suppl 7):S842-8.
²American Associated of Neurological Surgeons. Artificial cervical disc surgery. [AANS web site]. May 2016. Available here. Accessed March 27, 2017.