Cleared Traditional

ARTICUL/EZE Ceramic Heads

K222296 · Depuy Ireland UC · Orthopedic

Jan 2023

Decision

158d

Days

Class 2

Risk

About This 510(k) Submission

K222296 is an FDA 510(k) clearance for the ARTICUL/EZE Ceramic Heads, a Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (Class II — Special Controls, product code LZO), submitted by Depuy Ireland UC (Cork, IE). The FDA issued a Cleared decision on January 6, 2023, 158 days after receiving the submission on August 1, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K222296 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 01, 2022
Decision Date	January 06, 2023
Days to Decision	158 days
Submission Type	Traditional
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