FDA Clears Camber Spine Interbody Fusion Implant

FDA has cleared a Camber Spine 510(k) for the SPIRA-C Open Matrix Cervical Interbody device, an interbody fusion implant. The 3D-printed titanium implant is designed to enhance fusion, according to the company. It uses the company’s SPIRA Arch Technology that creates an environment for cell proliferation and bone growth. For short-term stability, “newly forming bone follows the multiple arches incorporated with the ‘Surface-By-Design’ to encourage ongrowth and ingrowth throughout the cage,” the company says.

The device is indicated for use at one or two contiguous levels in the cervical spine, from C3-C7, in skeletally mature patients who have had six weeks of non-operative treatment for the degenerative disk disease with up to Grade 1 spondylolisthesis, the company says. It is also intended to be used with additional FDA-cleared supplemental fixation systems.