Cleared Traditional

K033148 - ART ANTERIOR SPINAL SYSTEM

K033148 is an FDA 510(k) clearance for ART ANTERIOR SPINAL SYSTEM, manufactured by Advanced Medical Technologies AG. The device is a Class 2 Orthopedic device with product code KWQ cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K033148 · Advanced Medical Technologies AG · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
195d
Days
Class 2
Risk

K033148 is an FDA 510(k) clearance for the ART ANTERIOR SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Intervertebral Body (product code KWQ), Class II - Special Controls.

Submitted by Advanced Medical Technologies AG (Round Rock, US). The FDA issued a Cleared decision on April 12, 2004 after a review of 195 days - an extended review 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: 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 Advanced Medical Technologies AG devices

FDA 510(k) Submission Details - K033148

510(k) Number K033148 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2003
Decision Date April 12, 2004
Days to Decision 195 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d slower than avg
Panel avg: 122d · This submission: 195d
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 503
Devices cleared under the same product code (KWQ) and FDA review panel - the closest regulatory comparables to K033148.
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K040962 · Medtronic Sofamor Danek · May 2004
MODIFICATION TO CYCLONE ANTERIOR CERVICAL PLATE SYSTEM
K040397 · Encore Medical, L.P. · May 2004
REFLEX HYBRID ANTERIOR CERVICAL PLATE SYSTEM
K040261 · Stryker Spine · Apr 2004
EAGLE ANTERIOR CERVIAL PLATE SYSTEM
K040197 · Depuyacromed · Apr 2004
SYNTHES VENTROFIX MIS SYSTEM
K031100 · Synthes (Usa) · Mar 2004
SYNTHES ANTERIOR CERVICAL COMPRESSION SYSTEM
K033844 · Synthes (Usa) · Feb 2004