Cleared Traditional

K181307 - Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow

K181307 is an FDA 510(k) clearance for Zimmer Nexel Total Elbow, 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 256-day FDA review.

K181307 · Zimmer, Inc. · Orthopedic device
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Jan 2019
Decision
256d
Days
Class 2
Risk

K181307 is an FDA 510(k) clearance for the Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow. 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 January 28, 2019 after a review of 256 days - an extended review cycle.

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 - K181307

510(k) Number K181307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2018
Decision Date January 28, 2019
Days to Decision 256 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
134d slower than avg
Panel avg: 122d · This submission: 256d
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 K181307.
TEMA Elbow System
K181362 · Lima Corporate S.P.A. · Feb 2019
Comprehensive SRS/Nexel Elbow
K153398 · Biomet Manufacturing Corp · Feb 2016
Zimmer Nexel Total Elbow Ulnar Cement Diverter
K150501 · Zimmer, Inc. · Apr 2015
ZIMMER NEXEL TOTAL ELBOW
K123862 · Zimmer, Inc. · Mar 2013
DISCOVERY ELBOW - X-SMALL
K090473 · Biomet Manufacturing Corp · Mar 2009
ACCLAIM TOTAL ELBOW SYSTEM
K060696 · DePuy Orthopaedics, Inc. · Apr 2006