510(k) K243615

Physica Porous Femoral Components by Lima Corporate S.P.A. — Product Code MBH

K243615 is an FDA 510(k) premarket notification submitted by Lima Corporate S.P.A. for the device "Physica Porous Femoral Components". The FDA issued a decision of Substantially Equivalent on December 18, 2024. The device falls under product code MBH (Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3565. Lima Corporate S.P.A. has at least 10 other 510(k) clearances on record.