New Fitbone instead of the Precice Max?

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Do you know the price of the nails?

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Quote from: rotzputzen on October 06, 2024, 06:59:36 AMNo the discussion is not pointless as surgery can be done with Birkholtz or Germany, where the nail is already in use
Also, it has been FDA approved recently: https://www.medicaldevice-network.com/news/orthofix-fda-fitbone-system/

Here is the clearance letter: https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233867.pdf
According to the letter, it is available in 9, 11, and 13mm

Only the trochanteric (anterograde) entry nail for the femur has been cleared as far as I know

I could not find any source for CE mark approval of the new Fitbone nail. Do you have a source? because you said it is used in Germany.

In the US, no well known surgeon uses it for cosmetic. Do a search on the Fitbone surgeon directory.

South Africa is quite risky. I would not trust their medical board even if Dr Birkholtz is good. Getting a brand new nail inserted into both femur bones? better be sure that it has full regulatory approval of developed countries if you asking me

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Quote from: ax on October 06, 2024, 10:30:04 AMI could not find any source for CE mark approval of the new Fitbone nail. Do you have a source? because you said it is used in Germany.

In the US, no well known surgeon uses it for cosmetic. Do a search on the Fitbone surgeon directory.

South Africa is quite risky. I would not trust their medical board even if Dr Birkholtz is good. Getting a brand new nail inserted into both femur bones? better be sure that it has full regulatory approval of developed countries if you asking me

I sent Thaller an email but I guess you are corrent in that there is no EU approval yet only US - similar to the PMax nail.

Yes, you are correct in that using that nail in SA is probably quite risky. However, it does have regulatory approval by the FDA if that means anything. Also, I know of one Birkholtz patient who is 1.5cm into distraction with the new Fitbone and no issues thus far. Given the nail is made of Molybdenum it is unlikely to break - worst case scenario is probably that it stops distracting.
However, the P2.2 has issues with locking bolts.

The question still remains whether the increased weight-bearing during distraction outweighs the potential risks of it being a new decive.

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Quote from: rotzputzen on October 06, 2024, 12:19:44 PMI sent Thaller an email but I guess you are corrent in that there is no EU approval yet only US - similar to the PMax nail.

Yes, you are correct in that using that nail in SA is probably quite risky. However, it does have regulatory approval by the FDA if that means anything. Also, I know of one Birkholtz patient who is 1.5cm into distraction with the new Fitbone and no issues thus far. Given the nail is made of Molybdenum it is unlikely to break - worst case scenario is probably that it stops distracting.
However, the P2.2 has issues with locking bolts.

The question still remains whether the increased weight-bearing during distraction outweighs the potential risks of it being a new decive.

So far Birkholtz hasn't even used the new fitbone yet. Orthofix is saying it only had limited release in the US and has now put it on hold, it was still in the process of getting approval in South Africa before the hold so impossible for any patient there to have used it. No doubt the new fitbone is still a decent nail but all the delays mean surgeons will just go with the more popular Precise max when it's released again. Unfortunately Orthofix just took way too long to release the new fitbone when they could have had the market to themselves.

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Looks like the new precise is delayed until 2026, so Fitbone has an opportunity to capture the market this year. 

Anyone know why the delayed? Was it because of the precise max issues?

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Forget p max bro. Is out of the market

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    I do agreed. Pmax is just out even if goes out tomorrow I will chopse betz or other nail.. that ridiculous paley and that nail. They just can make a good FW nail, they just can’t .. after 5 years paley fail, 2 recalls is just a fail..

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I just got off a call with Dr. Birkholtz about my own surgery. He offers both the fitbone and p2.2, but he urged me to go with p2.2 since his installation and lengthening using p2.2 is a basic Tuesday, whereas fitbone is still experimental territory for him.

IMO this process is going to be filled with anxiety as is, and I don't want to be freaking out everyday over potential bent nail / alignment problems because I'm pushing the boundaries of a device that may or may not be properly weightbearing.

EDIT: grammar

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What's the cost of the surgery using fitbone nail with Dr. Birkholtz?

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same cost, I believe. He didn't mention any price difference.