Another doctor has just told me that Nuvasive will meet with the FDA next week, and that will determine if Stryde is allowed to be used during this months in the States. He also states that is realistic to expect this to be solved by summer and, in the worst case, to have at least Precice 2. I think that this meeting with the FDA will be really telling.
I thought Stryde was already FDA approved?
This is all just really confusing at the moment. Like las vegas said how are they going to prove or disprove anything in the space of just a few months, especially in terms of device toxicity. Really hope this was something that was blown out of proportion but its worrying that these questions are even being raised at all. This isn't like some consumer product with a flaw that gets taken off the shelves, peoples lives could be at risk.
You can be FDA approved and then have that approval revoked. Happens all the time. ISKD was an FDA approved nail that kept lengthening and was not accurate in distraction.
I had a consultation with Mahoubian a few days ago. He says that he definitely does not believe that the Stryde nail could be chipping off and causing cancer. He mentioned that he is waiting to hear back from the FDA - and should in two weeks. He has halted all new Stryde patients until then.
Just a question here: how much worse of an alternative is betzbone v2?
Betzbone break allot
What about fitbone? Some doctors are considering it
Quote from: Giotikas2021 on February 03, 2021, 08:39:12 PMWhat about fitbone? Some doctors are considering it
Eh it’s kinda stupid tbh, everyone needs to just calm down and wait. I’m sure within 3-6 months max stryde will be back. If not they will develop something else before the year ends I’m sure. I’ll be fkdd if I’m expected to pay the same price as stryde for a crappier product, betz/fit bone is trash compared to stryde, they’re not terrible but definitely not worth the same price
One of Paley's papers about the development of stryde states that they avoided a cobalt chrome based due to the potential for toxicity.
Stryde is stainless steel, precise titanium which are used in lots of implants but I don't know if the lengthening mechanism is different between the two nails and their components. If it is different then hopefully the issue won't be across both nails.
Most components should have gone through toxicity testing, I would imagine the tests will be looking at what forces release what quantities of components which should be fairly quick to perform to see if they reach potential toxic levels
Quote from: HeightGain on February 03, 2021, 09:47:15 PMOne of Paley's papers about the development of stryde states that they avoided a cobalt chrome based due to the potential for toxicity.
Stryde is stainless steel, precise titanium which are used in lots of implants but I don't know if the lengthening mechanism is different between the two nails and their components. If it is different then hopefully the issue won't be across both nails.
Most components should have gone through toxicity testing, I would imagine the tests will be looking at what forces release what quantities of components which should be fairly quick to perform to see if they reach potential toxic levels
Awesome post, really appreciate your insight.
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