Cleared Special

K022676 - ORTHOGUARD AB ANTIMICROBIAL SLEEVE

K022676 is an FDA 510(k) clearance for ORTHOGUARD AB ANTIMICROBIAL SLEEVE, manufactured by Smith & Nephew, Inc.. The device is a Class 2 Orthopedic device with product code JEC cleared through the Special 510(k) pathway after a 42-day FDA review.

K022676 · Smith & Nephew, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2002
Decision
42d
Days
Class 2
Risk

K022676 is an FDA 510(k) clearance for the ORTHOGUARD AB ANTIMICROBIAL SLEEVE. Classified as Component, Traction, Invasive (product code JEC), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on September 23, 2002 after a review of 42 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3040 - 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.

FDA 510(k) Submission Details - K022676

510(k) Number K022676 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2002
Decision Date September 23, 2002
Days to Decision 42 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
80d faster than avg
Panel avg: 122d · This submission: 42d
Pathway characteristics
Modification to existing cleared device.

JEC Device Classification - Class 2, Special Controls

Product Code JEC Component, Traction, Invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3040
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 - JEC Component, Traction, Invasive

All 84
Devices cleared under the same product code (JEC) and FDA review panel - the closest regulatory comparables to K022676.
FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM
K032427 · Meridan Medical · Oct 2003
HOFFMANN II COMPACT BALTIMORE COUPLING
K031941 · Howmedica Osteonics Corp. · Jul 2003
WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS
K030519 · Hand Biomechanics Lab, Inc. · Jun 2003
SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X
K022065 · Sintea Biotech, Inc. · Aug 2002
AMC ANTIMICROBIAL PIN/WIRE SLEEVE
K012193 · Smith & Nephew, Inc. · Jul 2002
AUTOGENESIS AUTOMATOR, MODEL M1000
K013818 · Autogenesis, Inc. · Dec 2001
K022676 · ORTHOGUARD AB ANTIMICROBIAL SLEEVE
Download PDF FDA Summary Smith & Nephew, Inc.