Cleared Traditional

K032659 - DEPUY ASR RESURFACING FEMORAL HEADS

K032659 is an FDA 510(k) clearance for DEPUY ASR RESURFACING FEMORAL HEADS, manufactured by DePuy Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code KXA cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K032659 · DePuy Orthopaedics, Inc. · Orthopedic device
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Dec 2003
Decision
98d
Days
Class 2
Risk

K032659 is an FDA 510(k) clearance for the DEPUY ASR RESURFACING FEMORAL HEADS. Classified as Prosthesis, Hip, Femoral, Resurfacing (product code KXA), Class II - Special Controls.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on December 4, 2003 after a review of 98 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3400 - 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: Standard predicate-based submission. Standard predicate reliance. 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

FDA 510(k) Submission Details - K032659

510(k) Number K032659 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 2003
Decision Date December 04, 2003
Days to Decision 98 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
24d faster than avg
Panel avg: 122d · This submission: 98d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KXA Device Classification - Class 2, Special Controls

Product Code KXA Prosthesis, Hip, Femoral, Resurfacing
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3400
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 - KXA Prosthesis, Hip, Femoral, Resurfacing

All 17
Devices cleared under the same product code (KXA) and FDA review panel - the closest regulatory comparables to K032659.
DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS
K070292 · Zimmer GmbH · Apr 2007
CONSERVE FEMORAL RESURFACING COMPONENT
K062960 · Wrightmedicaltechnologyinc · Dec 2006
BIOPRO TARA FEMORAL RESURFACING COMPONENT
K043542 · Biopro, Inc. · May 2005
PRESS-FIT HEAD RESURFACING DEVICE
K023188 · Biomet Orthopedics, Inc. · Dec 2002
CEMENTED FEMORAL HEAD RESURFING DEVICE
K021799 · Biomet Orthopedics, Inc. · Jun 2002
CORMET 2000 HEMI HIP METALLIC RESURFACING PROSTHESIS
K994153 · Corin USA · Feb 2000