Cleared Special

Persona the Personalized Knee System

K243247 · Zimmer, Inc. · Orthopedic

Oct 2024

Decision

18d

Days

Class 2

Risk

About This 510(k) Submission

K243247 is an FDA 510(k) clearance for the Persona the 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 29, 2024, 18 days after receiving the submission on October 11, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number	K243247 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 11, 2024
Decision Date	October 29, 2024
Days to Decision	18 days
Submission Type	Special
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