FDA clears SurGenTec synthetic bone graft

SurGenTec announced today that it received FDA 510(k) clearance for its proprietary OsteoFlo NanoPutty quadphasic synthetic bone graft.

Boca Raton, Fla.-based SurGenTec said in a news release that its novel OsteoFlo NanoPutty bone graft features the world’s first and only quadphasic synthetic bone graft particles with nano-surface technology for providing an “optimal resorption profile with unrivaled handling characteristics.”

OsteoFlo requires no mixing, reconstituting or preparation prior to use and is designed to maximize flowable properties when used in minimally invasive surgery. The putty does not harden and can flow through tiny apertures and voids.

The putty comes in two packaging configurations, either a standard syringe or a pre-filled, minimally invasive cartridge that can be used with SurGenTec’s GraftGun single-use bone graft delivery system.

SurGenTec is eyeing a launch for the OsteoFlo NanoPutty in October 20…

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