Ankle replacements moving main stage and one manufacturer took on the FDA of recent, and it has been so long that the patent has now run out so in effect it appears to be open ball game on the device that is currently used outside the US and has been for years.  BD

“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.”

WASHINGTON – What was left of Dan Sivia's ankle simply didn't work. He limped through his 30s by sheer force of will, one foot almost completely immobile from repeated broken bones and surgeries. Then a doctor offered his last hope: An ankle replacement. A what? Sivia knew about hip, knee, even shoulder replacements. But ankles?

His confusion is understandable: The first ankle replacements of the 1970s were abandoned when they couldn't withstand the pounding of daily life. A second generation in the '90s lasted longer but never became really popular.

Now the nation is embarking on a new generation of artificial ankles designed to work more like the joint you're born with, a move specialists hope finally will offer less pain and more function to thousands who hobble — although it's too soon to be sure.

In Europe, doctors also can use a similar but three-piece artificial ankle, where the plastic cushion is free-floating. Amid questions about whether that approach is better or worse, the FDA is evaluating whether to allow it here.

Related Reading from an earlier post

FDA Shackled at the Ankles?

UPDATE:  Endotec urged the agency to lower the classification to eliminate the need for more clinical studies in the past and were never accepted.  Then in 2006 the FDA filed a lawsuit.  Now the patient has expired and the judge stated patients can continue to benefit from the ankle replacement, but what else does this mean?  Well now that the patent protection is gone, other can manufacture such products, for a simple example, DePuy, a division of Johnson & Johnson, is conducting a clinical trial on a similar design.  There were issues with the original clinical trials, but the company still contends the device should have been downgraded and not in the same category as Class III devices, which include heart valves, pacemakers and some joint replacements and require clinical trials.  So where do you go when you need an ankle, out of the country?  BD





Technorati Tags: ,,


  1. While the expiration of patent protection is a hopeful sign for those awaiting new ankle replacement designs, the current functional design philosophy itself excludes many patients with severe ankle injuries from being 'good' candidates for replacement.

    Many of the designs being explored function via talar implants, but if patients have had catastrophic talar injuries, such a device may create additional difficulties related to mobility, pain, etc.

    The talus has a singularly difficult blood supply issue, and disruption and potential bone death as a result (avascular necrosis) are all complications ankle implant designers must take into account.

    How do I know? I'm waiting for a viable ankle replacement option after severe talar fractures and multiple surgical repairs.

    There is some great work in talar reconstruction going on at the University of Maryland Medical Center and Georgetown University Hospital in DC, so to answer your earlier question (do you have to go out of the country to get ankle replacements?), nope, you sure don't - just head to the Baltimore/DC area.

    Great article!

    Jen McCabe Gorman

  2. Thank you Jen for the update. Good information to help others and I hope your surgery goes well!


Google Analytics Alternative