Cleared Traditional

Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs)

K242543 · Zimmer, Inc. · Orthopedic

Nov 2024

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K242543 is an FDA 510(k) clearance for the Persona the Personalized Knee System (Persona Ti-Nidium PPS Femurs), 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 November 22, 2024, 88 days after receiving the submission on August 26, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number	K242543 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 26, 2024
Decision Date	November 22, 2024
Days to Decision	88 days
Submission Type	Traditional
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