SurGenTec Gains FDA Clearance for OsteoFlo NanoPutty

By Julie A. Vetalice

SurGenTec Gains FDA Clearance for OsteoFlo NanoPutty

SurGenTec received FDA 510(k) clearance to market OsteoFlo® NanoPutty®, a quadphasic synthetic bone graft. Product launch is slated for 4Q20.

Quadphasic scaffolding supports bone growth at different phases during the healing process. Nano surface technology increases surface area and stimulates cellular activity/osseointegration. Quadphasic scaffolding plus nano surface technology provide a synergistic effect to regenerate bone.

OsteoFlo requires no mixing, reconstituting or preparation, and is suitable for use in ambulatory surgical centers. The putty does not harden and can flow through tiny apertures and voids. Two packaging configurations are available: a standard syringe or a pre-filled minimally invasive cartridge that can be used with SurGenTec’s GraftGun® sterile single-use bone graft delivery system.

Travis Greenhalgh, Founder and Chief Executive Officer of SurGenTec, said, “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."

Product Labels: Synthetic Bone Graft

Tags: 510(k) Clearance, Regulatory