STAR ankle 510K Protection Expired?

I have heard that the 5 year window that the FDA grants to protect new devices from being 510K has recently expired and is open up to anyone making similar devices. Can anyone confirm this?

 

you are speaking jibberish. I don't work at sbi, but that's not the way fda works. total ankles are a PMA. any other ankle will also be a pma. 510k only applies to new products that are similar to products that were already on the market (and essentially grandfathered) prior to the 1976 Act.

 

wtf? lol, so, the FDA is now a patent office? you don't have any idea of what you're speaking about