510(k) for Interpore's AGF (autologous growth factor) collection system:
This article was originally published in Clinica
Executive Summary
The US FDA has cleared Interpore Cross International's UltraConcentrator permeability haemodialyser and automated processor. The products are components of a system used during bone grafting procedures for collecting autologous growth factors, a platelet-rich plasma derivative providing osteoinductive growth factors from the patient's blood. The automated processor provides a pneumatic, semi-automated method of driving a platelet-rich blood component called the buffy coat through the UltraConcentrator which, in turn, removes the water and concentrates the platelets and fibrin.