Ankles didn't’ come easy even with the FDA, as a matter of fact they sued on manufacturer and the company Endotec won. If you want one of their ankles I believe you still have to go out of the country as the battle began many years ago and the patent has now expired too.
“It's not often the little guy takes on the federal government and wins. Endotec, a small South Orange maker of orthopedic devices, did just that this summer after years of fighting with the Food and Drug Administration for permission to legally market its unique ankle joint replacement implant.”
As stated here, Medicare covers ankles but not too many insurance companies will do it. It must all be in those calculated algorithms they run to see if the benefit of the replacement is cost effective, never mind that the patient might enjoy a better quality of life with one. BD
It's been a decade since the U.S. Food and Drug Administration approved the first total ankle-replacement system for patients with severe ankle arthritis.
Since approving the first total ankle-replacement system in 1999, the FDA has approved two other systems and given tentative approval to a third system. In 2003, the American Orthopaedic Foot and Ankle Society issued a statement that said a total ankle replacement "is a viable option for the treatment of ankle arthritis." And Medicare routinely covers ankle replacements.
Nevertheless, several insurance companies still deny coverage. They base their decision on a "meta-analysis" that concluded an ankle replacement was not a preferred treatment option. The meta-analysis compiled data from previous studies. It was sponsored by insurance companies and based on studies published in 2002 or earlier, Pinzur wrote.
The FDA has approved ankle replacements, so why don't all insurance plans cover them?
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