Cleared Traditional

DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062

K040544 · Depuy, Inc. · Orthopedic

May 2004

Decision

87d

Days

Class 2

Risk

About This 510(k) Submission

K040544 is an FDA 510(k) clearance for the DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044 TO -062 AND 1599-21-044 TO -062, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (Class II — Special Controls, product code LPH), submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on May 28, 2004, 87 days after receiving the submission on March 2, 2004. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3358.

Submission Details

510(k) Number	K040544 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 02, 2004
Decision Date	May 28, 2004
Days to Decision	87 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