ReBOSSIS Bone Scaffold Gains FDA Clearance in Spine

By Julie A. Vetalice

ORTHOReBIRTH USA gained FDA 510(k) clearance to market ReBOSSIS® biosynthetic bone scaffold for use in posterolateral spine procedures.

The first 510(k) clearance for ReBOSSIS occurred in 2014, with an application in the pelvis and extremities. Since then, the material has surpassed the milestone of 1,500 procedures performed.

The resorbable cottony flexible synthetic bone material comprises calcium carbonate + silicate + polylactic acid, which is electrospun into fiber and can be mixed with autograft.

Tests have reportedly validated the material's support of cell activation, retention and proliferation, and ReBOSSIS has also demonstrated a 54% compression recovery rate.



Product Labels: Synthetic Bone Graft

Tags: 510(k) Clearance, Regulatory