Cleared Traditional

K140260 - SKYHAWK LATERAL PLATE SYSTEM

K140260 is an FDA 510(k) clearance for SKYHAWK LATERAL PLATE SYSTEM, manufactured by Orthofix, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K140260 · Orthofix, Inc. · Orthopedic device
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Jul 2014
Decision
149d
Days
Class 2
Risk

K140260 is an FDA 510(k) clearance for the SKYHAWK LATERAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Orthofix, Inc. (Lewisville, US). The FDA issued a Cleared decision on July 2, 2014 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 Orthofix, Inc. devices

FDA 510(k) Submission Details - K140260

510(k) Number K140260 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2014
Decision Date July 02, 2014
Days to Decision 149 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
27d slower than avg
Panel avg: 122d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KWQ Device Classification - Class 2, Special Controls

Product Code KWQ Appliance, Fixation, Spinal Intervertebral Body
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3060
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 - KWQ Appliance, Fixation, Spinal Intervertebral Body

All 589
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K140260.
OPTIO-C ANTERIOR CERVICAL SYSTEM
K141500 · Zimmer Spine, Inc. · Sep 2014
GENESYS SPINE ANTERIOR BUTTRESS PLATE SYSTEM
K133911 · Genesys Spine · Sep 2014
DIVERGENCE MINI-PLATE ANTERIOR CERVICAL FUSION SYSTEM
K140417 · Medtronic Sofamor Danek, Inc. · Jul 2014
DIAMOND RATTLESNAKE SYSTEM
K133194 · Eminent Spine · Jun 2014
META-C CERVICAL PLATE
K140361 · Medacta International · Jun 2014
ASPIRON ACP SYSTEM
K140234 · U&I Corp. · Jun 2014