www.fdanews.com/articles/193271-implanet-earns-510k-clearance-for-cemented-version-of-total-knee-prosthesis
Implanet Earns 510(k) Clearance for Cemented Version of Total Knee Prosthesis
October 30, 2019
Implant maker Implanet received 510(k) clearance from the FDA for the cemented version of its Madison total knee prosthesis.
The French device manufacturer supported its application with data accumulated over seven years from 17,000 implanted knee prostheses.
With the agency’s clearance, the knee prosthesis is now available in multiple versions, including cemented and cementless with hydroxyapatite coating.