510(k) K243293

Zimmer® Persona® Personalized Knee System by Zimmer Biomet — Product Code MBH

K243293 is an FDA 510(k) premarket notification submitted by Zimmer Biomet for the device "Zimmer® Persona® Personalized Knee System". The FDA issued a decision of Substantially Equivalent on December 20, 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 Biomet has at least 4 other 510(k) clearances on record.