Cleared Traditional

EMPHASYS Acetabular Shell with RapiTite HA

K242084 · Depuy Ireland UC · Orthopedic

Oct 2024

Decision

83d

Days

Class 2

Risk

About This 510(k) Submission

K242084 is an FDA 510(k) clearance for the EMPHASYS Acetabular Shell with RapiTite HA, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Depuy Ireland UC (Cork, IE). The FDA issued a Cleared decision on October 7, 2024, 83 days after receiving the submission on July 16, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K242084 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 16, 2024
Decision Date	October 07, 2024
Days to Decision	83 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