Cleared Traditional

ULTIMA METAL-ON-METAL ACETABULAR CUP (K001523) - FDA 510(k) Clearance

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

K001523 · DePuy Orthopaedics, Inc. · Orthopedic device
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Aug 2000
Decision
86d
Days
Class 3
Risk

K001523 is an FDA 510(k) clearance for the ULTIMA METAL-ON-METAL ACETABULAR CUP. 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 10, 2000 after a review of 86 days - a notably fast clearance cycle.

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. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all DePuy Orthopaedics, Inc. devices

Submission Details

510(k) Number K001523 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2000
Decision Date August 10, 2000
Days to Decision 86 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
36d faster than avg
Panel avg: 122d · This submission: 86d
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.

Regulatory Peers - KWA Prosthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)

All 57
Devices cleared under the same product code (KWA) and FDA review panel - the closest regulatory comparables to K001523.
DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
K003523 · DePuy Orthopaedics, Inc. · Dec 2000
PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS
K002883 · DePuy Orthopaedics, Inc. · Oct 2000
M2A 28MM RINGLOC LINER
K002379 · Biomet, Inc. · Aug 2000
METAL ON METAL ACETABULAR SYSTEM
K993438 · Biomet, Inc. · May 2000
OMNIFLEX NORMALIZED HIP STEM FOR PRESS-FIT FIXAT.
K872768 · Osteonics Corp. · Jan 1988
(MODIFIED) OMNIFIT THREADED ACETABULAR COMPONENT
K861723 · Osteonics Corp. · Jun 1986