510(k) K251166

Mfinity Femoral System by Medacta International S.A. — Product Code MEH

K251166 is an FDA 510(k) premarket notification submitted by Medacta International S.A. for the device "Mfinity Femoral System". The FDA issued a decision of Substantially Equivalent on June 13, 2025. The device falls under product code MEH (Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate), a Class II device regulated under 21 CFR 888.3353. Medacta International S.A. has at least 10 other 510(k) clearances on record.