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Medical Devices / Submissions and Approvals

DT MedTech Wins FDA Clearance for Ankle Replacement System

Nov. 14, 2017

DT MedTech’s Hintermann Series H2 total ankle replacement system received 510(k) clearance from the FDA.

The device 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, primary arthritis, and secondary arthritis.

The Hintermann Series H2 is for patients with a failed total ankle replacement or non-union/mal-union of the ankle arthrodesis, if sufficient bone stock is present.

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