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[rotzputzen]

The new Fitbone nail seems to support full weight bearing below 200lbs. Seems to be much better than the mechanical nails (G-nail, Betzbone). Seems like a PMax replacement worth considering. Am I missing something?
Why is it not discussed more around here?

[1team]

Where did you hear it supported full weight bearing below 200lbs?

[rotzputzen]

A few people were discussing it on the d server. Also in a recent consult with Victor (Cyborg4Life) he mentioned something similar. Like the PMax it only has a weight-approval of much less but the max fatigue load seems to be not much different from the PMax. Birkholtz started using it on a few CLL patients. Still off-label for increased weight bearing. This is just what I have heard, thus my thread

[1team]

I heard from an orthofix rep that it has been pulled from market for more testing, date of return is unknown at this stage.

[Body Builder]

Fitbone was always very unreliabe. Many times it stopped working.
I wouldn't trust it as an alternative to precise max.

[rotzputzen]

Fitbone was always very unreliabe. Many times it stopped working.
I wouldn't trust it as an alternative to precise max.

I just looked at the literature. In this study (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9940487/) there were not many additional complications compared to the precice system. Also this study by Peter Thaller https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7744673/ also does not seem to have many device-related complications.

Given the renewed delay of the PMax, the question becomes whether the weight-bearing abilities outweigh the small increase in device-related complications.

[wes07]

What's the cost for 2 nails only?

[ax]

this discussions is point less until the nail is approved in your country (FDA, CE, MHRA etc. etc)

I would not use any nail until approved by them and a reputable surgeon offers it

[Rockstarz5]

Yeah dr paley and his team really sucks

[rotzputzen]

No 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

[wes07]

Do you know the price of the nails?

[ax]

No 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

[rotzputzen]

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

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.

[1team]

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.

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.