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boston745

11/04/22 9:52 PM

#38609 RE: madg #38608

Yet it literally says it's for acquiring third party IPR&D. Sorry if thats inconvienent.

Now why do you ignore that fact that a third party company submitted a Si3N4 related arthroplasty device to a regulatory agency? Its not Sintx that submitted it. That means its either Zimmer utilizing Sintx MC2 femoral head or a different company working on Si3N4 femoral head. Based on the information in Sintx 10k only MC2 could be submitted via a 510k as its substantially equivalent to Biolox Delta. The coating they are working on would require PMA if I understood it correctly. But Sintx isnt submitting a hip implant so that means a partner is required.
If Zimmer submitted, as evidence suggests, then the submission is based on Sonnys design at Missouri S&T. Payment for that IP would be required. It makes sense for Zimer to have acquired the IP in 2017 after femoral head testing was complete. It could then take over the project from there.