Cleared Special

PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES (K052069) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K052069 · Globus Medical, Inc. · Orthopedic device
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Aug 2005
Decision
16d
Days
Class 2
Risk

K052069 is an FDA 510(k) clearance for the PROTEX STABILIZATION SYSTEM WITH ADDITIONAL COMPONENTES. 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 August 17, 2005 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3050 - the FDA orthopedic device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Globus Medical, Inc. devices

Submission Details

510(k) Number K052069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 2005
Decision Date August 17, 2005
Days to Decision 16 days
Submission Type Special
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
106d faster than avg
Panel avg: 122d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

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 K052069.
MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM
K052376 · Medtronic Sofamor Danek · Sep 2005
VERTEX RECONSTRUCTION SYSTEM
K052402 · Medtronic Sofamor Danek · Sep 2005
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM
K052180 · Medtronic Sofamor Danek · Aug 2005
PROTEX CT CERVICOTHORACIC SPINAL SYSTEM
K050391 · Globus Medical, Inc. · Jul 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