Cleared Special

Zimmer Biomet Ceramic Heads (22.2mm diameter)

K250834 · Zimmer Biomet · Orthopedic

Apr 2025

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K250834 is an FDA 510(k) clearance for the Zimmer Biomet Ceramic Heads (22.2mm diameter), a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Zimmer Biomet (Warsaw, US). The FDA issued a Cleared decision on April 18, 2025, 30 days after receiving the submission on March 19, 2025. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K250834 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 19, 2025
Decision Date	April 18, 2025
Days to Decision	30 days
Submission Type	Special
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LZO — Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3353