FDA on the low end of the Endotec Ruling - Mobile Ankle devices are ok - Medical Devices

This is amazing that the battle has gone on over 25 years to restrict these devices from use in the US. The judge said they are"custom-made medical devices exempt from FDA regulation". This marks the first loss in the court room for the FDA on a suit they brought to task.

The judge asked who had been harmed by the device...well there was a blank slate there. As time marches on there no doubt will be a more transparent FDA in the future. BD

But, if the Food and Drug Administration (FDA) had its way, Capricci would have never received the surgery that allows him to hunt, fish and bike. In 2006, the FDA sued Endotec claiming the company had distributed unapproved joint replacement devices. For 25 years the FDA has pursued a policy which has prevented custom mobile bearings ankle joints from reaching the US market. Mobile bearing ankle devices are used exclusively outside the US, which means that US citizens must travel abroad for this treatment.