Cleared Traditional

Zimmer Persona Personalized Knee System

K222566 · Zimmer, Inc. · Orthopedic

Oct 2022

Decision

54d

Days

Class 2

Risk

About This 510(k) Submission

K222566 is an FDA 510(k) clearance for the Zimmer Persona Personalized Knee System, 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 October 17, 2022, 54 days after receiving the submission on August 24, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number	K222566 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 24, 2022
Decision Date	October 17, 2022
Days to Decision	54 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