HINTERMANN ANKLE REPLACEMENT RECEIVES RARE FDA APPROVAL (Orthopedics This Week)
After almost three years of FDA review, DT MedTech, LLC has won FDA premarket approval (PMA) for its Hintermann Series H3 total ankle replacement system.
PMAs are a big deal. No 510(k)-clearance tinkering at the edges to get a device to market in the cheapest, quickest way possible. The company submitted its application in August 2016. The FDA granted approval on June 4, 2019.
The System
According to a June 5, 2019 announcement by the company, the ankle replacement system is a three-piece, mobile-bearing implant “…...
