The additional information has been submitted already since October 2016. This is the time Ed said they submitted the information there is a PR already in regards to this. Please do not twist my words, if you have a question about what I said just ask.
This news is already known to many here. BIEL submitted the extra information to FDA couple of months back,while FDA is reviewing the hugs registry data we are waiting. If FDA feels it's not enough (Thousands of registry data should be enough) then they can clear Knee and insole and wait for more time for the rest. BIEL is providing all the info needed by FDA to have a single clearance for all applications.