Cleared Traditional

K021740 - TOTAL KNEE CEMENTED, SEMI-CONSTRAINED

K021740 is an FDA 510(k) clearance for TOTAL KNEE CEMENTED, manufactured by Dj Orthopedics, LLC. The device is a Class 2 Orthopedic device with product code JWH cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K021740 · Dj Orthopedics, LLC · Orthopedic device
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Sep 2002
Decision
118d
Days
Class 2
Risk

K021740 is an FDA 510(k) clearance for the TOTAL KNEE CEMENTED, SEMI-CONSTRAINED. Classified as Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer (product code JWH), Class II - Special Controls.

Submitted by Dj Orthopedics, LLC (Vista, US). The FDA issued a Cleared decision on September 23, 2002 after a review of 118 days - within the typical 510(k) review window.

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 Dj Orthopedics, LLC devices

FDA 510(k) Submission Details - K021740

510(k) Number K021740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 2002
Decision Date September 23, 2002
Days to Decision 118 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 122d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JWH Device Classification - Class 2, Special Controls

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 879
Devices cleared under the same product code (JWH) and FDA review panel - the closest regulatory comparables to K021740.
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NEXGEN COMPLETE KNEE SOLUTION CRUCIATE RETAINING (CR)-FLEX FEMORAL COMPONENTS
K023211 · Zimmer, Inc. · Oct 2002
TOTAL KNEE FEMORAL COMPONENT
K022010 · Smith & Nephew, Inc. · Aug 2002
ANTERIOR STABILIZED TIBIAL BEARINGS
K022586 · Biomet Orthopedics, Inc. · Aug 2002
UKNEE TOTAL KNEE SYSTEM
K021657 · United Orthopedic Corp. · Aug 2002