Cleared Traditional

K042544 - UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM

K042544 is the FDA 510(k) clearance for UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM by Depuy Spine, Inc.. It is a Class 2 Orthopedic device (product code KWQ) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K042544 · Depuy Spine, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Nov 2004
Decision
64d
Days
Class 2
Risk

K042544 is an FDA 510(k) clearance for the UNIPLATE 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 November 23, 2004 after a review of 64 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Depuy Spine, Inc. devices

Submission Details

510(k) Number K042544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 20, 2004
Decision Date November 23, 2004
Days to Decision 64 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
58d faster than avg
Panel avg: 122d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K042544.
PIONEER ANTERIOR CERVICAL PLATE SYSTEM
K043066 · Pioneer Surgical Technology · Feb 2005
GAPP GRAFT CONTIANMENT DEVICE ORTHOPEDICS
K031782 · Medtronic Sofamor Danek · Feb 2005
MODIFICATION TO: CD HORIZON SPINAL SYSTEM
K043151 · Medtronic Sofamor Danek · Feb 2005
VENTURE ANTERIOR CERVICAL PLATING SYSTEM
K042922 · Medtronic Sofamor Danek, Inc. · Nov 2004
ORION ANTERIOR CERVICAL PLATING SYSTEM
K042499 · Medtronic Sofamor Danek · Oct 2004
ORION ANTERIOR CERVICAL PLATING SYSTEM
K042235 · Medtronic Sofamor Danek · Sep 2004