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.
Premarket approval for the latest version of the implant, also known as the H3, was backed by data that showed 95.9% of patients were moderately satisfied to very satisfied at 5 years post-surgery, according to a summary of FDA data included in the press release.
“I am proud of this achievement. Since implanting the first H3, it has been a dream to bring the H3 to the U.S. market and enhance patient care and outcomes,” Beat Hintermann, MD, developer of both H3 and H2 implants, said in the release.
The H3 is a three-piece, mobile-bearing implant used in cases of pain due to primary osteoarthritis, arthritis secondary to inflammatory disease or post-traumatic OA.
“We are pleased to have received this approval for the H3,” David Reicher, president and CEO of DT MedTech, said in the release. “I want to thank Dr. Beat Hintermann and his team, everyone at M Squared Associates, our advisors and key stakeholders, and all of our Data Trace employees for their perseverance and tireless work in achieving this momentous goal.”