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# Icotec Carbon Fiber Spinal Infection Implant Cleared
- URL: https://www.fdaweb.com/icotec-carbon-fiber-spinal-infection-implant-cleared/
- Published: 2025-01-14T12:00:00.000Z
- Updated: 2026-09-14T14:50:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158485

FDA has cleared an Icotec 510(K) for the use of its BlackArmor carbon fiber implants for treating de novo spinal infections, including discitis, osteomyelitis, pyogenic infection of the intervertebral disc, and other spondylopathies. Icotec’s implant offers “reduced artifacts from radiolucent Carbon/PEEK material,” which the company says enables improved imaging and infection monitoring in post-operative settings.

“Over 15,000 patients receive spinal stabilizations due to an infection in the spine in the U.S. every year,” a company release says. The clearance was based on clinical study data that demonstrated safety and equivalent complication rates to titanium implants, it adds.