Cleared Traditional

K040389 - COONRAD/MORREY ELBOW CEMENT RESTRICTOR

K040389 is an FDA 510(k) clearance for COONRAD/MORREY ELBOW CEMENT RESTRICTOR, manufactured by Zimmer, Inc.. The device is a Class 2 Orthopedic device with product code JDC cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K040389 · Zimmer, Inc. · Orthopedic device
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May 2004
Decision
90d
Days
Class 2
Risk

K040389 is an FDA 510(k) clearance for the COONRAD/MORREY ELBOW CEMENT RESTRICTOR. Classified as Prosthesis, Elbow, Constrained, Cemented (product code JDC), Class II - Special Controls.

Submitted by Zimmer, Inc. (Warsaw, US). The FDA issued a Cleared decision on May 17, 2004 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3150 - 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 Zimmer, Inc. devices

FDA 510(k) Submission Details - K040389

510(k) Number K040389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2004
Decision Date May 17, 2004
Days to Decision 90 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 faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDC Device Classification - Class 2, Special Controls

Product Code JDC Prosthesis, Elbow, Constrained, Cemented
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3150
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 - JDC Prosthesis, Elbow, Constrained, Cemented

All 27
Devices cleared under the same product code (JDC) and FDA review panel - the closest regulatory comparables to K040389.
COONRAD/MORREY TOTAL ELBOW, MODEL 8105 SERIES
K053189 · Zimmer, Inc. · Dec 2005
POROUS COATED DISCOVERY ELBOW
K051975 · Biomet, Inc. · Sep 2005
LPS UPPER EXTREMITY
K042664 · Depuy, Inc. · Dec 2004
DISCOVERY ELBOW-MOSAIC DISTAL HUMERAL REPLACEMENT SYSTEM
K033280 · Biomet, Inc. · Dec 2003
DISCOVERY ELBOW
K013042 · Biomet Orthopedics, Inc. · Oct 2001
BIOMET'S MINIMALLY CONSTRAINED ELBOW
K003253 · Biomet, Inc. · Jan 2001