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?
Where did you hear it supported full weight bearing below 200lbs?
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
I heard from an orthofix rep that it has been pulled from market for more testing, date of return is unknown at this stage.
Fitbone was always very unreliabe. Many times it stopped working.
I wouldn't trust it as an alternative to precise max.
Quote from: Body Builder on October 05, 2024, 10:05:45 AMFitbone 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.
What's the cost for 2 nails only?
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
Yeah dr paley and his team really sucks
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
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