Cleared Special

EMPHASYS Femoral Stems

K233233 · Depuy Ireland UC · Orthopedic

Oct 2023

Decision

13d

Days

Class 2

Risk

About This 510(k) Submission

K233233 is an FDA 510(k) clearance for the EMPHASYS Femoral Stems, 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 October 11, 2023, 13 days after receiving the submission on September 28, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3353.

Submission Details

510(k) Number	K233233 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 28, 2023
Decision Date	October 11, 2023
Days to Decision	13 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