Cleared Special

K041106 - REVISION KNEE SYSTEM

K041106 is the FDA 510(k) clearance for REVISION KNEE SYSTEM by Smith & Nephew, Inc.. It is a Class 2 Orthopedic device (product code JWH) cleared through the Special 510(k) pathway after a 64-day FDA review.

K041106 · Smith & Nephew, Inc. · Orthopedic device
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Jul 2004
Decision
64d
Days
Class 2
Risk

K041106 is an FDA 510(k) clearance for the REVISION KNEE SYSTEM. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on July 1, 2004 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3560 - 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 Smith & Nephew, Inc. devices

Submission Details

510(k) Number K041106 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 28, 2004
Decision Date July 01, 2004
Days to Decision 64 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
58d faster than avg
Panel avg: 122d · This submission: 64d
Pathway characteristics
Modification to existing cleared device.

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 777
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K041106.
LPS (LIMB PRESERVATION SYSTEM) LOWER EXTREMITY DOVETAIL INTERCALARY
K041085 · Depuy, Inc. · Jul 2004
LPS METAPHYSEAL SLEEVE (LIMB PRESERVATION SYSTEM)
K040281 · DePuy Orthopaedics, Inc. · Jul 2004
LPS
K033959 · Depuy, Inc. · Jul 2004
TITANIUM FEMORAL KNEE COMPONENTS (MAXIM AND AGC)
K041466 · Biomet Manufacturing Corp · Jul 2004
TECRES SPACER-K TEMPORARY KNEE PROSTHESIS
K032522 · Exactech, Inc. · May 2004
SCORPIO TOTAL KNEE SYSTEM - POSTERIOR STABILIZED TIBIAL INSERTS
K040964 · Howmedica Osteonics Corp. · May 2004