Cleared Traditional

Persona Personalized Knee System

K221479 · Zimmer, Inc. · Orthopedic

Nov 2022

Decision

178d

Days

Class 2

Risk

About This 510(k) Submission

K221479 is an FDA 510(k) clearance for the Persona Personalized Knee System, a Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (Class II — Special Controls, product code JWH), submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on November 17, 2022, 178 days after receiving the submission on May 23, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K221479 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 23, 2022
Decision Date	November 17, 2022
Days to Decision	178 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	JWH — Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3560