Cleared Traditional

K040442 - PROTEX STABILIZATION SYSTEM

K040442 is an FDA 510(k) clearance for PROTEX STABILIZATION SYSTEM, manufactured by Globus Medical, Inc.. The device is a Class 2 Orthopedic device with product code MNH cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K040442 · Globus Medical, Inc. · Orthopedic device
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May 2004
Decision
90d
Days
Class 2
Risk

K040442 is an FDA 510(k) clearance for the PROTEX STABILIZATION SYSTEM. Classified as Orthosis, Spondylolisthesis Spinal Fixation (product code MNH), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Phoenixville, US). The FDA issued a Cleared decision on May 20, 2004 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 Globus Medical, Inc. devices

FDA 510(k) Submission Details - K040442

510(k) Number K040442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2004
Decision Date May 20, 2004
Days to Decision 90 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
32d faster than avg
Panel avg: 122d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNH Device Classification - Class 2, Special Controls

Product Code MNH Orthosis, Spondylolisthesis Spinal Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
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 - MNH Orthosis, Spondylolisthesis Spinal Fixation

All 277
Devices cleared under the same product code (MNH) and FDA review panel - the closest regulatory comparables to K040442.
MX POLYAXIAL PEDICLE SCREW
K043001 · Scient'X · Dec 2004
UNI-THREAD SPINAL SYSTEM
K042640 · Spine Vision, Inc. · Nov 2004
MX MONOAXIAL PEDICLE SCREW
K042964 · Scient'X · Nov 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K034056 · Medtronic Sofamor Danek · Apr 2004
NUVASIVE SPINAL SYSTEM
K033546 · Nuvasive, Inc. · Apr 2004
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K040072 · Medtronic Sofamor Danek, Inc. · Feb 2004