Cleared Traditional

K041205 - EXPEDIUM ANTERIOR SPINE SYSTEM

K041205 is an FDA 510(k) clearance for EXPEDIUM ANTERIOR SPINE 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 102-day FDA review.

K041205 · Depuy Spine, Inc. · Orthopedic device
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Aug 2004
Decision
102d
Days
Class 2
Risk

K041205 is an FDA 510(k) clearance for the EXPEDIUM ANTERIOR SPINE 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 August 17, 2004 after a review of 102 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 - K041205

510(k) Number K041205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2004
Decision Date August 17, 2004
Days to Decision 102 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
20d faster than avg
Panel avg: 122d · This submission: 102d
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 K041205.
ORION ANTERIOR CERVICAL PLATING SYSTEM
K042499 · Medtronic Sofamor Danek · Oct 2004
ORION ANTERIOR CERVICAL PLATING SYSTEM
K042235 · Medtronic Sofamor Danek · Sep 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K042025 · Medtronic Sofamor Danek, Inc. · Aug 2004
NUVASIVE ANTERIOR CERVICAL PLATE SYSTEM
K041447 · Nuvasive, Inc. · Aug 2004
MACROPORE HYDROSORB SPINE SYSTEM
K041105 · Macropore Biosurgery, Inc. · Jul 2004
C-TEK C-THRU ANTERIOR CERVICAL PLATE SYSTEM
K041794 · Interpore Cross Intl. · Jul 2004