Dear list members,
Is anyone aware of pending changes to the current status of FDA approval
for osseointegration procedures?
In 2015 osseoanchored prostheses were designated for ‘Humanitarian Use’.
I have been asked by an amputee if the FDA designation will be expanded.
Apparently he was advised by an orthopedic surgeon that he is a candidate
for the procedure and will be their initial case, but that they are awaiting
FDA expansion of the approved use.
Thank you for any insights.
Dennis Farrell, CP