Cleared Traditional

Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella)

K240299 · Zimmer, Inc. · Orthopedic

Apr 2024

Decision

85d

Days

Class 2

Risk

About This 510(k) Submission

K240299 is an FDA 510(k) clearance for the Persona the Personalized Knee System (Persona OsseoTi 3-Peg Patella), 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 April 26, 2024, 85 days after receiving the submission on February 1, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3565.

Submission Details

510(k) Number	K240299 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 01, 2024
Decision Date	April 26, 2024
Days to Decision	85 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