Cleared Traditional

EMPHASYS? Dual Mobility System

K231522 · Depuy Ireland UC · Orthopedic

Feb 2024

Decision

265d

Days

Class 2

Risk

About This 510(k) Submission

K231522 is an FDA 510(k) clearance for the EMPHASYS? Dual Mobility System, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Depuy Ireland UC (Cork Munster, IE). The FDA issued a Cleared decision on February 15, 2024, 265 days after receiving the submission on May 26, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K231522 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 26, 2023
Decision Date	February 15, 2024
Days to Decision	265 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	LPH — Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3358