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DT MedTech Receives 510(k) Clearance for Hintermann Total Ankle

DT MedTech (DTM) received FDA 510(k) clearance to market the Hintermann Series H2™ Total Ankle Replacement, a semi-constrained cemented prosthesis for primary or revision surgery. Limited launch is slated for late 4Q17 ex-U.S., where it has already secured CE Mark Approval.

Developed by Dr. Beat Hintermann, the Hintermann Series H2 is also indicated for patients with a failed total ankle replacement or non-union/mal-union of the ankle arthrodesis, provided that there is enough bone stock. Series H2 will be distributed in the U.S. by HealthLink Europe, based in Raleigh, North Carolina, and through specialized and select distributors. 

DTM already markets the mobile-bearing Hintermann Series H3 total ankle in over 30 countries ex-U.S., where the product has a reported 17 years of established clinical efficacy. Hintermann products for the lower extremity also include the Kalix® II subtalar arthrodesis implant to treat flatfoot deformities and instrumentation to support the implantable devices.

DT MedTech is a medical device manufacturer with a focus on lower extremities. The company has a U.S. location in Baltimore and European locations in Dublin and the Netherlands.

Source: DT MedTech, LLC

 

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