Cleared Traditional

K050391 - PROTEX CT CERVICOTHORACIC SPINAL SYSTEM

K050391 is an FDA 510(k) clearance for PROTEX CT CERVICOTHORACIC SPINAL SYSTEM, manufactured by Globus Medical, Inc.. The device is a Class 2 Orthopedic device with product code KWP cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K050391 · Globus Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K050391

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.

KWP Device Classification - Class 2, Special Controls

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 387
Devices cleared under the same product code (KWP) and FDA review panel - the closest regulatory comparables to K050391.
MODIFICATION TO: XIA STAINLESS STEEL SYSTEM
K051973 · Stryker Spine · Aug 2005
PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES
K052069 · Globus Medical, Inc. · Aug 2005
MALIBU SPINAL SYSTEM
K051942 · Seaspine, Inc. · Jul 2005
ZODIAC SPINAL FIXATION SYSTEM
K050830 · Alphatec/Nexmed · Jun 2005
CD HORIZON SPINAL SYSTEM
K050809 · Medtronic Sofamor Danek USA, Inc. · Jun 2005
BASIS SPINAL SYSTEM
K050484 · Medtronic Sofamor Danek, Inc. · May 2005