Cleared Traditional

Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)

K253189 · Zimmer, Inc. · Orthopedic

Mar 2026

Decision

164d

Days

Class 2

Risk

About This 510(k) Submission

K253189 is an FDA 510(k) clearance for the Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs), a Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer (Class II — Special Controls, product code MBH), submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on March 9, 2026, 164 days after receiving the submission on September 26, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number	K253189 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 2025
Decision Date	March 09, 2026
Days to Decision	164 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MBH — Prosthesis, Knee, Patello/femorotibial, Semi-constrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3565