SurGenTec earned additional FDA clearance for its OsteoFlo HydroFiber, according to a July 22 news release.
The new 510(k) clearance adds indications for use as a bone void filler for the treatment of tumors, cysts, trauma, and osteomyelitis.
“Treating tumors and osteomyelitis presents significant challenges with limited options available,” Travis Greenhalgh, CEO and founder of SurGenTec, said in the release. “Our technology offers a powerful, autograft-equivalent solution, providing optimal clinical outcomes without the need for autograft harvesting. This allows physicians to avoid the invasive procedure and risks associated with autograft while still delivering exceptional results, positioning our product as the superior choice over allograft.”
OsteoFlo HydroFiber previously earned FDA clearance as a stand-alone equivalent to autografts in spine surgeries. It is designed for use in interbody fusion cages, disc spaces, and posterolateral fusions. The product can also be used with SurGenTec’s Graftgun for backfilling interbody cages.
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