Cleared Special

K103491 - SKYLINE ANTERIOR CERVICAL PLATE SYSTEM

K103491 is an FDA 510(k) clearance for SKYLINE ANTERIOR CERVICAL PLATE SYSTEM, manufactured by A Johnson & Johnson Company. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Special 510(k) pathway after a 80-day FDA review.

K103491 · A Johnson & Johnson Company · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
80d
Days
Class 2
Risk

K103491 is an FDA 510(k) clearance for the SKYLINE ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by A Johnson & Johnson Company (Raynham, US). The FDA issued a Cleared decision on February 14, 2011 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3060 - 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 - K103491

510(k) Number K103491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 2010
Decision Date February 14, 2011
Days to Decision 80 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
42d faster than avg
Panel avg: 122d · This submission: 80d
Pathway characteristics
Modification to existing cleared device.

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 663
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K103491.
NUVASIVE TRAVERSE PLATE SYSTEM
K103750 · Nuvasive, Inc. · Mar 2011
PSL ANTERIOR CERVICAL PLATE SYSTEM
K103819 · Precision Surgery , Ltd. · Feb 2011
FIXED VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM
K103838 · Precision Surgery , Ltd. · Feb 2011
VENUS ANTERIOR CERVICAL PLATE
K103137 · Verticor, Ltd. · Feb 2011
GOLDEN GATE ANTERIOR PLATE SYSTEM
K101353 · Ulrich GmbH & Co. KG · Feb 2011
POLARIS SPINAL SYSTEM
K103393 · Biomet Spine · Feb 2011
K103491 · SKYLINE ANTERIOR CERVICAL PLATE SYSTEM
Download PDF FDA Summary A Johnson & Johnson C…