Cleared Traditional

Persona Partial Knee

K251834 · Zimmer Biomet · Orthopedic

Aug 2025

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K251834 is an FDA 510(k) clearance for the Persona Partial Knee, a Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer (Class II — Special Controls, product code HSX), submitted by Zimmer Biomet (Warsaw, US). The FDA issued a Cleared decision on August 15, 2025, 60 days after receiving the submission on June 16, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3520.

Submission Details

510(k) Number	K251834 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 16, 2025
Decision Date	August 15, 2025
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	HSX — Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3520