Cleared Special

K040655 - SWIFT ANTERIOR CERVICAL PLATE SYSTEM

K040655 is the FDA 510(k) clearance for SWIFT ANTERIOR CERVICAL PLATE SYSTEM by Depuy Spine, Inc.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Special 510(k) pathway after a 82-day FDA review.

K040655 · Depuy Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
82d
Days
Class 2
Risk

K040655 is an FDA 510(k) clearance for the SWIFT ANTERIOR CERVICAL PLATE SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Depuy Spine, Inc. (Raynham, US). The FDA issued a Cleared decision on June 2, 2004 after a review of 82 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.

View all Depuy Spine, Inc. devices

Submission Details

510(k) Number K040655 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2004
Decision Date June 02, 2004
Days to Decision 82 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
40d faster than avg
Panel avg: 122d · This submission: 82d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 373
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K040655.
NUVASIVE ANTERIOR CERVICAL PLATE SYSTEM
K041447 · Nuvasive, Inc. · Aug 2004
CD HORIZON SPINAL SYSTEM
K041460 · Medtronic Sofamor Danek USA, Inc. · Jul 2004
ASSURE ANTERIOR CERVICAL PLATE SYSTEM
K040721 · Globus Medical, Inc. · Jun 2004
MODIFICATION TO BONE GRAFT WASHER
K041217 · Medtronic Sofamor Danek, Inc. · May 2004
ABC CAUDAL AND CRANIAL EXTENSION PLATE (E-PLATE)
K040017 · Aesculap, Inc. · May 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K040962 · Medtronic Sofamor Danek · May 2004