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# Icotec 510(k) Cleared for Vader Pedicle Screw
- URL: https://www.fdaweb.com/icotec-510-k-cleared-for-vader-pedicle-screw/
- Published: 2019-07-12T12:00:00.000Z
- Updated: 2026-09-15T01:37:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144523

FDA has cleared an Icotec 510(k) for the Vader One pedicle screw system for use in both minimally-invasive and open spine surgical procedures. The device, which is made from Icotec’s BlackArmor carbon/PEEK (polyetheretherketone) material, was designed for “secure stabilization and post-operative visualization, which is important after spinal tumor procedures,” the company says. It is produced using the company’s injection composite flow molding manufacturing technology. “This process allows for 3-dimensionally reinforced, nonmetallic implants providing both, the strength and radiolucency needed for oncology patients and their treatment,” it says.