Thursday, March 30, 2023

Osseointegration U.S.

Dennis Farrell, CP

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
Milwaukee, WI

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