Orthofix Granted Additional FDA Clearance for FIREBIRD SI Fusion

By Julie A. Vetalice

Orthofix Granted Additional FDA Clearance for FIREBIRD SI Fusion

Orthofix Medical received FDA 510(k) clearance for the NANOVATE™ nanotechnology feature of the FIREBIRD™ SI Fusion system. Initially cleared and launched earlier this year, FIREBIRD SI Fusion is reportedly the first 3D-printed titanium bone screw with nanotechnology specifically designed to compress and stabilize the sacroiliac joint (SI joint) during fusion.

The device is packed with autograft and/or allograft, like MTF Biologics' Trinity ELITE,  to promote fusion. FIREBIRD SI screws are available in an assortment of lengths and diameters.

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory