Cleared Special

K062066 - OMEGA 3 SYSTEM

K062066 is the FDA 510(k) clearance for OMEGA 3 SYSTEM by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code KTT) cleared through the Special 510(k) pathway after a 25-day FDA review.

K062066 · Howmedica Osteonics Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2006
Decision
25d
Days
Class 2
Risk

K062066 is an FDA 510(k) clearance for the OMEGA 3 SYSTEM. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Howmedica Osteonics Corp. (Mahwah, US). The FDA issued a Cleared decision on August 15, 2006 after a review of 25 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - 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 Howmedica Osteonics Corp. devices

Submission Details

510(k) Number K062066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2006
Decision Date August 15, 2006
Days to Decision 25 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
97d faster than avg
Panel avg: 122d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
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 - KTT Appliance, Fixation, Nail/blade/plate Combination, Multiple Component

All 276
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K062066.
OMEGA 3 SUPRACONDYLAR PLATE
K070454 · Howmedica Osteonics Corp. · Apr 2007
DEPUY PEAK FX HIP PLATE
K063509 · DePuy Orthopaedics, Inc. · Jan 2007
AEQUALIS HUMERAL PLATE
K063551 · Tornier · Dec 2006
UNITY HUMERAL PLATE
K060545 · Tornier · Apr 2006
VARIAX LOCKING PLATE SYSTEM
K060613 · Howmedica Osteonics Corp. · Apr 2006
REPROCESSED EXTERNAL FIXATION DEVICES
K052918 · Alliance Medical Corp. · Jan 2006