Cleared Traditional

Persona? Revision Knee System (Persona Revision SoluTion? Femoral Components)

K243724 · Zimmer, Inc. · Orthopedic

Mar 2025

Decision

93d

Days

Class 2

Risk

About This 510(k) Submission

K243724 is an FDA 510(k) clearance for the Persona? Revision Knee System (Persona Revision SoluTion? Femoral Components), 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 6, 2025, 93 days after receiving the submission on December 3, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3560.

Submission Details

510(k) Number	K243724 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 03, 2024
Decision Date	March 06, 2025
Days to Decision	93 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