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MedShape receives FDA 510(k) clearance for tibiotalocalcaneal fusion system

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MedShape Inc. announced it has received FDA 510(k) clearance for the DynaNail XL tibiotalocalcaneal fusion system, which the company expects to launch in early 2018.

According to a press release, the DynaNail is available in 260-mm and 300-mm lengths for patients with longer tibial anatomies or for those who underwent failed fusion procedures with an intramedullary (IM) nail. When combined with the DynaNail’s pseudoelastic nickel titanium compressive element, the DynaNail XL can decrease stress risers in the bone and therefore reduce the risk of tibial fractures.

“The recent additions the DyNaNail portfolio demonstrate our continued commitment toward improving upon the success of the company’s flagship product,” Kurt Jacobs, MedShape CEO, said in the release. “We have been pleased with the growing adoption of this unique technology by both orthopedic surgeons and podiatrists and anticipate continued growth with these new offerings.”

Reference:

www.medshape.com