Cleared Special

K063551 - AEQUALIS HUMERAL PLATE

K063551 is the FDA 510(k) clearance for AEQUALIS HUMERAL PLATE by Tornier. It is a Class 2 Orthopedic device (product code KTT) cleared through the Special 510(k) pathway after a 28-day FDA review.

K063551 · Tornier · Orthopedic device
Download Printable Device Report (PDF)
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Dec 2006
Decision
28d
Days
Class 2
Risk

K063551 is an FDA 510(k) clearance for the AEQUALIS HUMERAL PLATE. Classified as Appliance, Fixation, Nail/blade/plate Combination, Multiple Component (product code KTT), Class II - Special Controls.

Submitted by Tornier (Saint-Ismier Cedex, FR). The FDA issued a Cleared decision on December 22, 2006 after a review of 28 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 Tornier devices

Submission Details

510(k) Number K063551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2006
Decision Date December 22, 2006
Days to Decision 28 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
94d faster than avg
Panel avg: 122d · This submission: 28d
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 271
Devices cleared under the same product code (KTT) and FDA review panel - the closest regulatory comparables to K063551.
BIOMET VISION FOOTRING SYSTEM
K071395 · Biomet Manufacturing Corp · Jul 2007
OMEGA 3 SUPRACONDYLAR PLATE
K070454 · Howmedica Osteonics Corp. · Apr 2007
DEPUY PEAK FX HIP PLATE
K063509 · DePuy Orthopaedics, Inc. · Jan 2007
OMEGA 3 SYSTEM
K062066 · Howmedica Osteonics Corp. · Aug 2006
UNITY HUMERAL PLATE
K060545 · Tornier · Apr 2006
VARIAX LOCKING PLATE SYSTEM
K060613 · Howmedica Osteonics Corp. · Apr 2006