The STAR™ Ankle is used world-wide for more ankle replacements than any other device. It has a long clinical history – the current design has been in use for over 20 years, and prior generations of the STAR were approved for use as early as 1978. The STAR is the only 3-piece mobile bearing total ankle available in the United States, as approval for such a device in the US requires a rigorous FDA PMA process that is very expensive and time-consuming. The process to get the STAR approved took nearly 10 years, and was approved in 2009.
The STAR has been well documented and analyzed in papers. One of the best ways to understand the effectiveness of joint replacements is to consider a statistic called the ‘survivability’ of the implant – which is the likelihood that a device will remain implanted for a particular number of years. The STAR has been shown in clinical papers to have a 90% likelihood to remain implanted for 10 years. No other total ankle replacement approved for use in the US has published any survivability information for their implants.