Cleared Special

K081278 - OMEGA 3 TROCHANTERIC STABILIZING PLATE

K081278 is the FDA 510(k) clearance for OMEGA 3 TROCHANTERIC STABILIZING PLATE by Howmedica Osteonics Corp.. It is a Class 2 Orthopedic device (product code KTT) cleared through the Special 510(k) pathway after a 23-day FDA review.

K081278 · Howmedica Osteonics Corp. · Orthopedic device
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May 2008
Decision
23d
Days
Class 2
Risk

K081278 is an FDA 510(k) clearance for the OMEGA 3 TROCHANTERIC STABILIZING PLATE. 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 May 29, 2008 after a review of 23 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 K081278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2008
Decision Date May 29, 2008
Days to Decision 23 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
99d faster than avg
Panel avg: 122d · This submission: 23d
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 K081278.
REPROCESSED EXTERNAL FIXATION DEVICE
K081586 · Sterilmed, Inc. · Aug 2008
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K081342 · Sterilmed, Inc. · Aug 2008
VARIAX DISTAL FIBULA PLATE
K081284 · Howmedica Osteonics Corp. · Jul 2008
JET-X BAR SYSTEM CLAMPS, BARS AND POSTS-MR SAFE
K072212 · Smith & Nephew, Inc. · Mar 2008
HOFFMANN LIGHT SYSTEM
K073076 · Howmedica Osteonics Corp. · Feb 2008
VARIAX ELBOW SYSTEM
K073527 · Howmedica Osteonics Corp. · Feb 2008