FDA Clears DT MedTech’s Hintermann Series H2 Total Ankle Replacement System

DT MedTech, LLC (DTM) announced that the Hintermann Series H2 Total Ankle Replacement System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA).
 
The Hintermann Series H2 is a semi-constrained, total ankle replacement prosthesis developed by Prof. Beat Hintermann, a world-renowned foot and ankle surgeon based in Liestal, Switzerland. The Hintermann Series H2 Total Ankle Replacement System is indicated for use with bone cement to treat ankle arthritis in either primary or revision surgery of ankle joints damaged by systemic arthritis of the ankle (e.g., rheumatoid arthritis, hemochromatosis), primary arthritis (e.g., degenerative disease), and secondary arthritis (e.g., post-traumatic, avascular necrosis). 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 sufficient bone stock is present. The Intellectual Property of the Hintermann Series H2 is protected by numerous patents with additional patents pending.
 
DTM’s Hintermann Series H2 sales and distribution in the United States will be handled directly through its logistics partner HealthLink Europe International from its US headquarters located in Raleigh, N.C., and through specialized and select distributors.
 
David Reicher, president and CEO of DTM, stated, “We are extremely pleased to receive marketing clearance from the FDA for our innovative Hintermann Series H2 Total Ankle Replacement System. I want to thank our employees, M Squared Associates and other advisors, and key stakeholders, who were all so instrumental in helping DT MedTech achieve this momentous milestone.”
 
DTM continues to market and distribute its Hintermann Series H3 mobile-bearing Total Ankle Replacement System outside of the United States in over 30 countries. The Hintermann Series H3 is a substantiated leader for the international ankle replacement market with more than 17 years of proven clinical efficacy outside of the United States.
 
Prof. Beat Hintermann, developer of the Hintermann Series Total Ankle Systems, stated, “I am looking forward to adding the H2 as a semi-constrained option for my patients alongside the H3* mobile-bearing prosthesis. With the addition of the new H2 prosthesis, I will be able to expand my indications and patient selection for total ankle replacements.”
 
DTM anticipates a limited release of the Hintermann Series H2 in early December 2017 outside the United States, as it has already received the CE mark for the device, along with registrations in many additional key markets. DTM will be focusing on training, sales, and distribution of the Hintermann Series H2 in the United States markets and in markets outside the United States through DT MedTech International Limited (DTMI), DTM’s subsidiary and distribution arm located in Dublin, Ireland, in the upcoming months.
 
*Hintermann Series H3 is not available for sale within the United States and its territories.