Cleared Traditional

K180210 - CREO Stabilization System

K180210 is the FDA 510(k) clearance for CREO Stabilization System by Globus Medical, Inc.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K180210 · Globus Medical, Inc. · Orthopedic device
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Apr 2018
Decision
68d
Days
Class 2
Risk

K180210 is an FDA 510(k) clearance for the CREO® 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 April 2, 2018 after a review of 68 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Globus Medical, Inc. devices

Submission Details

510(k) Number K180210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2018
Decision Date April 02, 2018
Days to Decision 68 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
54d faster than avg
Panel avg: 122d · This submission: 68d
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 661
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K180210.
AXIS 5.5 Lumbar Pedicle Screw System
K180301 · Axis Orthopaedics · Apr 2018
Patriot Spinal Fixation System
K180324 · Valorus Spine · Apr 2018
K2M Patient Specific Rods
K180376 · K2m, Inc. · Apr 2018
CapLOX II® / TowerLOX® MIS Pedicle Screw System
K180475 · Captiva Spine, Inc. · Mar 2018
Mega Plus Spine System
K173180 · Bk Meditech, Co., Ltd. · Mar 2018
X-spine Cortical Bone Screw System
K180153 · X-Spine Systems, Inc. · Mar 2018