Cleared Traditional

K052546 - AEGIS ANTERIOR LUMBAR PLATE SYSTEM

K052546 is the FDA 510(k) clearance for AEGIS ANTERIOR LUMBAR 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 140-day FDA review.

K052546 · Depuy Spine, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Feb 2006
Decision
140d
Days
Class 2
Risk

K052546 is an FDA 510(k) clearance for the AEGIS ANTERIOR LUMBAR 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 February 3, 2006 after a review of 140 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 Depuy Spine, Inc. devices

Submission Details

510(k) Number K052546 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2005
Decision Date February 03, 2006
Days to Decision 140 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
18d slower than avg
Panel avg: 122d · This submission: 140d
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 K052546.
VENTURE ANTERIOR CERVICAL PLATE SYSTEM
K061274 · Medtronic Sofamor Danek · May 2006
EBI ANTERIOR CERVICAL PLATE SYSTEM
K060379 · Ebi, L.P. · Mar 2006
NUVASIVE SMARTPLATE GRADIENT PLUS SYSTEM
K053581 · Nuvasive, Inc. · Feb 2006
PACP SYSTEM
K053053 · Pioneer Surgical Technology · Nov 2005
HYBRID ANTERIOR CERVICAL PLATE SYSTEM
K052552 · Depuy Spine, Inc. · Oct 2005
BLACKSTONE UNITY ANTERIOR LUMBAR PLATE FIXATION SYSTEM
K043548 · Blackstone Medical, Inc. · Jun 2005