Cleared Traditional

K052546 - AEGIS ANTERIOR LUMBAR PLATE SYSTEM

K052546 is an FDA 510(k) clearance for AEGIS ANTERIOR LUMBAR PLATE SYSTEM, manufactured by Depuy Spine, Inc.. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K052546 · Depuy Spine, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K052546

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.

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 552
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K052546.
SLIMPLICITY ANTERIOR CERVICAL PLATE SYSTEM
K060025 · Spinal USA · Apr 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
SPIDER CERVICAL PLATING (SCP) SYSTEM
K052292 · X-Spine Systems, Inc. · Oct 2005
HYBRID ANTERIOR CERVICAL PLATE SYSTEM
K052552 · Depuy Spine, Inc. · Oct 2005