Cleared Traditional

PROTEX CT CERVICOTHORACIC SPINAL SYSTEM (K050391) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K050391 · Globus Medical, Inc. · Orthopedic device
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Optimized for regulatory review, auditing and printing
Jul 2005
Decision
155d
Days
Class 2
Risk

K050391 is an FDA 510(k) clearance for the PROTEX CT CERVICOTHORACIC SPINAL SYSTEM. Classified as Appliance, Fixation, Spinal Interlaminal (product code KWP), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Phoenixville, US). The FDA issued a Cleared decision on July 21, 2005 after a review of 155 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - 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

Submission Details

510(k) Number K050391 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2005
Decision Date July 21, 2005
Days to Decision 155 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
33d slower than avg
Panel avg: 122d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KWP Appliance, Fixation, Spinal Interlaminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3050
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 - KWP Appliance, Fixation, Spinal Interlaminal

All 98
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K050391.
VERTEX RECONSTRUCTION SYSTEM
K052402 · Medtronic Sofamor Danek · Sep 2005
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K052180 · Medtronic Sofamor Danek · Aug 2005
PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES
K052069 · Globus Medical, Inc. · Aug 2005
CD HORIZON SPINAL SYSTEM
K050809 · Medtronic Sofamor Danek USA, Inc. · Jun 2005
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K043053 · Medtronic Sofamor Danek · Apr 2005
CD HORIZON SPINAL SYSTEM
K050079 · Medtronic Sofamor Danek USA, Inc. · Feb 2005