MedShape Receives FDA Clearance for DynaNail XL

By Julie A. Vetalice

MedShape received FDA 510(k) clearance to market DynaNail® XL, a tibiotalocalcaneal fusion system, which is slated for early 2018 launch. "XL" refers to new 260mm and 300mm lengths that extend DynaNail's use to patients with longer tibial anatomies or those with prior failed fusion procedures using an intramedullary nail.

The original DynaNail Intramedullary Fusion Nail was FDA-cleared in 2011 and clinically launched in 2012. The platform is reportedly the only internal fusion device that employs pseudoelastic properties of Nitinol to provide compression like that of an external frame.

At the end of 2Q17, the company launched DynaFrame™ CF, a carbon fiber-filled PEEK deployment system for implanting the DynaNail TTC Fusion system. Compared to the original PEEK, the CF system provides up to 18x more rigidity and also includes accommodations for larger patient anatomies.

Sources: MedShape, Inc.; ORTHOWORLD Inc.

Product Labels: Lower Extremity

Tags: 510(k) Clearance, Regulatory