Spine devicemaker icotec earned FDA 510(k) clearance for its BlackArmor spine implants, according to a Jan. 14 news release.
The implants have indications to treat de novo spinal infections. Icotec is the first company to earn the FDA's clearance for stabilizing the spine in infection cases such as discitis, osteomyelitis, pyogenic infection of the intervertebral disc and other spondylopathies.
BlackArmor implants have reduced artifacts from radiolucent carbon/PEEK material, which improves imaging postoperatively.
Along with the FDA nod, CMS approved BlackArmor implants for its New Technology Add-on Payment, the release said.