510(k) K250980

Physica System (Physica CR Porous Femoral components) by Lima Corporate S.P.A. — Product Code MBH

K250980 is an FDA 510(k) premarket notification submitted by Lima Corporate S.P.A. for the device "Physica System (Physica CR Porous Femoral components)". The FDA issued a decision of Substantially Equivalent on May 22, 2025. 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.