Cleared Traditional

K040627 - DEPUY ASR MODULAR ACETABULAR CUP SYSTEM (FDA 510(k) Clearance)

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K040627 · DePuy Orthopaedics, Inc. · Orthopedic device
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Aug 2005
Decision
514d
Days
Class 3
Risk

K040627 is an FDA 510(k) clearance for the DEPUY ASR MODULAR ACETABULAR CUP SYSTEM. Classified as Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component) (product code KWA), Class III - Premarket Approval.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on August 5, 2005 after a review of 514 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3330 - 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: High-complexity regulatory submission. High regulatory complexity profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Orthopedic submissions.

View all DePuy Orthopaedics, Inc. devices

Submission Details

510(k) Number K040627 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 09, 2004
Decision Date August 05, 2005
Days to Decision 514 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
392d slower than avg
Panel avg: 122d · This submission: 514d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KWA Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 888.3330
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.