Cleared Traditional

LPS METAPHYSEAL SLEEVE (LIMB PRESERVATION SYSTEM) (K040281) - FDA 510(k) Clearance

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

K040281 · DePuy Orthopaedics, Inc. · Orthopedic device
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Jul 2004
Decision
154d
Days
Class 2
Risk

K040281 is an FDA 510(k) clearance for the LPS METAPHYSEAL SLEEVE (LIMB PRESERVATION SYSTEM). Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by DePuy Orthopaedics, Inc. (Warsaw, US). The FDA issued a Cleared decision on July 9, 2004 after a review of 154 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - 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

Submission Details

510(k) Number K040281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 2004
Decision Date July 09, 2004
Days to Decision 154 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
32d slower than avg
Panel avg: 122d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3560
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 - JWH Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

All 523
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K040281.
NEXGEN COMPLETE KNEE SOLUTION LPS-FLEX PROLONG HIGHLY CROSSLINKED POLYETHYLENE ARTICULAR SURFACES
K042271 · Zimmer, Inc. · Oct 2004
SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS
K041591 · Howmedica Osteonics Corp. · Sep 2004
LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY
K041085 · Depuy, Inc. · Jul 2004
LPS
K033959 · Depuy, Inc. · Jul 2004
REVISION KNEE SYSTEM
K041106 · Smith & Nephew, Inc. · Jul 2004
TECRES SPACER-K TEMPORARY KNEE PROSTHESIS
K032522 · Exactech, Inc. · May 2004