DT MedTech LLC has received FDA premarket approval for its Hintermann Series H3 Total Ankle Replacement System, according to a press release from the company.

Since its release in May 2000 and prior to the FDA approval, the non-cemented implant used to replace arthritic ankle joints was only available outside of the United States. An earlier model, the Hintermann Series H2, received 510(k) clearance in November 2017.