Implants made by Additive Manufacturing process approved by USFDA

mpfizer

Involved In Discussions
#1
Hi,

Would like to know which are the orthopedic implants approved by USFDA manufactured by using Additive manufacturing process .

Also which are the metallic materials approved by USFDA for AM process and their relevant ISO / ASTM standards.

Are there any PEEK implants manufactured by AM process and approved by USFDA .

Thanks

Michella
 
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QM_123

Starting to get Involved
#2
Hi,

Here you can find some ASTM standards related with AM:
Additive Manufacturing Technology Standards

I have no idea on orthopaedic implants manufactured through AM process, but I know some spinal and cervical cages have got FDA approval. You can find them with a google search ( Sorry, I don't want to give the 510k link of any company here so as not to be advertising). Hope this helps.
 
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