New Total Ankle Replacement cleared in the US
HINTERMANN H2 ANKLE REPLACEMENT CLEARED IN U.S. (Orthopedics This Week)
The Hintermann Series H2 Total Ankle Replacement System (H2) manufactured by DT MedTech, LLC is now cleared for sale in the U.S.
The H2 is a semi-constrained, total ankle replacement prosthesis developed by Professor Beat Hintermann, M.D., a foot and ankle surgeon based in Liestal, Switzerland.
The 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).
It 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.
In a November 8, 2017 announcement of the FDA 510(k) clearance, the company said it anticipates a limited release of the system in early December 2017 outside the U.S., as it has already received the CE mark for the device, along with registrations in other markets. The company said it will be focusing on training, sales, and distribution of the system in all markets through DT MedTech International Limited, DTM’s subsidiary and distribution arm located in Dublin, Ireland, in the upcoming months.
DT MedTech maintain offices in Baltimore, Maryland; Dublin, Ireland; Saint-Louis, France; and Liestal, Switzerland