Cleared Special

Persona Revision Knee System

K210551 · Zimmer, Inc. · Orthopedic

Mar 2021

Decision

21d

Days

Class 2

Risk

About This 510(k) Submission

K210551 is an FDA 510(k) clearance for the Persona Revision 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 March 18, 2021, 21 days after receiving the submission on February 25, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K210551 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 25, 2021
Decision Date	March 18, 2021
Days to Decision	21 days
Submission Type	Special
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