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) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K040544 · Depuy, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
87d
Days
Class 2
Risk

K040544 is an FDA 510(k) clearance for the DURALOC OPTION ACETABULAR CUP SYSTEM, MODELS 1599-01-044 TO -066, 1599-11-044.... Classified as Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented (product code LPH), Class II - Special Controls.

Submitted by Depuy, Inc. (Warsaw, US). The FDA issued a Cleared decision on May 28, 2004 after a review of 87 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3358 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Depuy, Inc. devices

Submission Details

510(k) Number K040544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 122d · This submission: 87d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3358
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - LPH Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

All 324
Devices cleared under the same product code (LPH) and FDA review panel - the closest regulatory comparables to K040544.
VERSYS HIP SYSTEM BEADED MIDCOAT LOW HEAD CENTER HIP PROSTHESIS, MODEL 00-7840-XXX-XX
K042776 · Zimmer, Inc. · Nov 2004
EXACTECH 12/14 TOTAL HIP SYSTEM
K041906 · Exactech, Inc. · Sep 2004
ZIMMER ANATOMIC II HIP PROSTHESIS
K041109 · Zimmer, Inc. · Jul 2004
TRIFLANGE II ACETABULAR CUP SYSTEM
K040383 · DePuy Orthopaedics, Inc. · May 2004
DEPUY PINNACLE ACETABULAR CUP SYSTEM, ESL MARATHON POLYETHYLENE LINERS, AND DEPUY ULTIMA UNIPOLAR FEMORAL HEADS
K033273 · DePuy Orthopaedics, Inc. · May 2004
SPECTRUM MODULAR SYSTEM
K033893 · DePuy Orthopaedics, Inc. · Mar 2004