Cleared Special

K031803 - DEPUY CERAMIC FEMORAL HEADS

K031803 is an FDA 510(k) clearance for DEPUY CERAMIC FEMORAL HEADS, manufactured by DePuy Orthopaedics, Inc.. The device is a Class 2 Orthopedic device with product code LZO cleared through the Special 510(k) pathway after a 20-day FDA review.

K031803 · DePuy Orthopaedics, Inc. · Orthopedic device
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Jul 2003
Decision
20d
Days
Class 2
Risk

K031803 is an FDA 510(k) clearance for the DEPUY CERAMIC FEMORAL HEADS. Classified as Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented (product code LZO), Class II - Special Controls.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 1, 2003 after a review of 20 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3353 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all DePuy Orthopaedics, Inc. devices

FDA 510(k) Submission Details - K031803

510(k) Number K031803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 2003
Decision Date July 01, 2003
Days to Decision 20 days
Submission Type Special
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
102d faster than avg
Panel avg: 122d · This submission: 20d
Pathway characteristics
Modification to existing cleared device.

LZO Device Classification - Class 2, Special Controls

Product Code LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3353
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 - LZO Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

All 451
Devices cleared under the same product code (LZO) and FDA review panel - the closest regulatory comparables to K031803.
MS-30 FEMORAL STEM STANDARD AND LATERAL
K040803 · Zimmer, Inc. · Apr 2004
MODIFICATION TO DEPUY CERAMIC FEMORAL HEAD
K040644 · DePuy Orthopaedics, Inc. · Apr 2004
STELKAST 32MM MODULAR CERAMIC FEMORAL HEAD
K033944 · Stelkast Company · Mar 2004
ALUMINA CERAMIC FEMORAL HEADS, 28 AND 32 MM
K030724 · Zimmer, Inc. · Jun 2003
ALUMINA V40 FEMORAL HEADS
K023901 · Howmedica Osteonics Corp. · Jan 2003
ASCENDENT ACETABULAR SYSTEM
K022985 · Sulzer Orthopedics, Inc. · Dec 2002