Yes, good catch on the joint implants. They are a higher class in the EU than the US. The impression in general is that EU classifications are somehow less strict or easier or lower, and that’s not actually true in modern times. As you can see with the joints, it’s often the reverse.

Another example: in the EU any device with a new biomaterial is automatically Class III, even if other devices that do the same thing are a lower class. In the US you could get a good regulatory person to pass that off as a Class II in many cases.