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Tuesday, 01/29/2019 2:33:49 PM

Tuesday, January 29, 2019 2:33:49 PM

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Now the other day I was PO'd they updated their website with "developing SiNi implants" and argued the implantation of a hip in 2011 to suggest they're not doing squat, or I`m mad at the lack of progress. So what's the big hold up on dropping sini coatings on chrome cobalt or Sintered femoral heads. Within their own literature they suggest a hip would require a 2-3 year clinical study and a knee would require a 510K. I guess the 2-3 year study is a big hold up to just shut it all down it's not happening and dissolution of the company due to loss of capital is the major concern. That looks almost behind them.

Now interesting that the stars aligned on the FDA's new systems of clearance. Even more interesting is a media blitz over metallosis over the weekend before that was announced, noted on the Chief of the FDA's own twitter as having no effect on the FDA's decisions to change the system as they where planning it before hand.
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