510(k) K242543

Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs) by Zimmer, Inc. — Product Code MBH

K242543 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)". The FDA issued a decision of Substantially Equivalent on November 22, 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. Zimmer, Inc. has at least 10 other 510(k) clearances on record.