Cleared Traditional

REVERE 4.5 STABILIZATION SYSTEM (K113395) - FDA 510(k) Clearance

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

K113395 · Globus Medical, Inc. · Orthopedic device
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Jun 2012
Decision
210d
Days
Class 2
Risk

K113395 is an FDA 510(k) clearance for the REVERE 4.5 STABILIZATION SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on June 14, 2012 after a review of 210 days - an extended review cycle.

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

Submission Details

510(k) Number K113395 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received November 17, 2011
Decision Date June 14, 2012
Days to Decision 210 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
88d slower than avg
Panel avg: 122d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To Fusion.
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 - NKB Thoracolumbosacral Pedicle Screw System

All 401
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K113395.
REVERE STABILIZATION SYSTEM
K122226 · Globus Medical, Inc. · Oct 2012
BEACON STABILIZATION SYSTEM
K121922 · Globus Medical, Inc. · Jul 2012
CD HORIZON SPINAL SYSTEM
K121680 · Medtronic Sofamor Danek USA, Inc. · Jul 2012
CD HORIZON SPINAL SYSTEM
K113174 · Medtronic Sofamor Danek USA, Inc. · Nov 2011
CD HORIZON(R) SPINAL SYSTEM
K112555 · Medtronic Sofamor Danek USA, Inc. · Sep 2011
TSRH SPINAL SYSTEMS
K111942 · Medtronic Sofamor Danek USA, Inc. · Aug 2011