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DT MedTech Granted PMA for Hintermann H3 Total Ankle

DT MedTech received FDA premarket approval (PMA) for the Hintermann Series H3™ Total Ankle Replacement. The three-piece mobile-bearing system is indicated for non-cemented use, and has been implanted in more than 20,000 patients ex-U.S. since launch in 2000.

The H3 was developed by Prof. Dr. Beat Hintermann, a world-renowned foot and ankle surgeon based in Liestal, Switzerland. 

Prof. Dr. Hintermann stated, "I am very 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. We have seen stellar H3 results outside of the U.S. and look forward to now being able to provide American surgeons with this TAR."

Clinical data used in the PMA showed that 95.9% of H3 patients were moderately to very satisfied with the procedure at five years post-implantation, with survivorship of 88% at seven years. Further, patients receiving the H3 had fewer serious device-related adverse events (other than a revision or removal) at two years post-op vs. those receiving another similar system.

DTM will market H3 alongside the Hintermann Series H2® two-piece, cemented, semi-constrained system that received FDA 510(k) clearance to market in 4Q17.

The H3 ankle is the second FDA-approved three-piece mobile bearing ankle implant on the U.S. market, following Stryker's Scandinavian Total Ankle Replacement (STAR).

 



Julie A. Vetalice
is ORTHOWORLD’s Editorial Assistant.

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