First-time US FDA clearance for Nuvasive’s greater than two-level cervical interbody implant system

Nuvasive CoRoent

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Nuvasive for the CoRoent small interbody system indicated for intervertebral body fusion at multiple contiguous levels in the cervical spine. This marks the first US clearance for a cervical cage to be used at up to four contiguous levels.

The NuVasive CoRoent small interbody system is an interbody cage manufactured from PEEK-Optima (Invibio) that provides stabilisation 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).