510(k) K241059

Pantheon Proximal Femur Reconstruction (PFR) System by Adler Ortho S.P.A — Product Code LPH

K241059 is an FDA 510(k) premarket notification submitted by Adler Ortho S.P.A for the device "Pantheon Proximal Femur Reconstruction (PFR) System". The FDA issued a decision of Substantially Equivalent on January 13, 2025. The device falls under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented), a Class II device regulated under 21 CFR 888.3358.