FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

DT MedTech Earns Premarket Approval for Ankle Replacement Implant

June 6, 2019

DT MedTech’s Hintermann Series H3, a total ankle replacement system, has received the FDA’s premarket approval.

The three-piece, mobile-bearing implant is indicated for use as a non-cemented implant to replace a painful arthritic ankle joint due to primary osteoarthritis, post-traumatic osteoarthritis or arthritis secondary to inflammatory disease.

The implant, which has been approved and used successfully outside of the U.S., was developed by Swiss foot and ankle surgeon Beat Hintermann.

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