FDA Clears Implants for Spinal Tumors/Infection Revisions

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The U.S. Food and Drug Administration (FDA) has granted two 510(k) clearances for implants which restore the integrity of the spine in tumor and infection cases.

According to the FDA documents, the first system is indicated to “provide the surgeon with a minimally invasive and open approach for posterior spinal surgery,” and is further intended to “restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion.”