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SurGenTec announced today that it received FDA 510(k) clearance for its proprietary OsteoFlo NanoPutty quadphasic synthetic bone graft. Ferric Pyrophosphate
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 2020, and also plans to garner CE Mark approval to market it overseas.
“We are thrilled to announce the addition of OsteoFlo NanoPutty to our portfolio. Our team has put years into research and development to create this truly unique synthetic bone graft putty,” SurGenTec founder & CEO Travis Greenhalgh said in the release. “Our team managed to put four biocompatible materials with different resorption profiles into one particle with nano-surface technology. These particles are also suspended in a unique combination of bioresorbable polymers that give the product superior handling characteristics.”
Filed Under: 510(k), Food & Drug Administration (FDA), Orthopedics, Regulatory/Compliance Tagged With: FDA, SurGenTec
Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at firstname.lastname@example.org.
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