Cleared Special

Persona? Personalized Knee System

K230321 · Zimmer, Inc. · Orthopedic

Mar 2023

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K230321 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 March 8, 2023, 30 days after receiving the submission on February 6, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K230321 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 06, 2023
Decision Date	March 08, 2023
Days to Decision	30 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