510(k) K253189

Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs) by Zimmer, Inc. — Product Code MBH

K253189 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)". The FDA issued a decision of Substantially Equivalent on March 9, 2026. 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.