Cleared Traditional

K231850 - QUARTEX Occipito-Cervico-Thoracic Spina...

K231850 is the FDA 510(k) clearance for QUARTEX Occipito-Cervico-Thoracic Spina... by Globus Medical, Inc.. It is a Class 2 Orthopedic device (product code NKG) cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K231850 · Globus Medical, Inc. · Orthopedic device
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Mar 2024
Decision
265d
Days
Class 2
Risk

K231850 is an FDA 510(k) clearance for the QUARTEX® Occipito-Cervico-Thoracic Spinal System ExcelsiusGPS® Instruments. Classified as Posterior Cervical Screw System (product code NKG), Class II - Special Controls.

Submitted by Globus Medical, Inc. (Audubon, US). The FDA issued a Cleared decision on March 14, 2024 after a review of 265 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3075 - 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 K231850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2023
Decision Date March 14, 2024
Days to Decision 265 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
143d slower than avg
Panel avg: 122d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKG Posterior Cervical Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3075
Definition Posterior Cervical Screw Systems Are Intended For Use In Fusion Procedures Of The Cervical Spine And/or Craniocervical Junction And/or Cervicothoracic Junction For: 1) Spinal Fractures And Dislocations; 2) Deformities; 3) Instabilities; 4) Failed Previous Fusions; 5) Tumors; 6) Inflammatory Disorders; 7) Spinal Degeneration, 8) Facet Degeneration With Instability; And 9) Reconstruction Following Decompression To Treat Radiculopathy And/or Myelopathy. These Systems Are Also Intended To Stabilize The Spine In The Absence Of Fusion For A Limited Time Period In Patients With Tumors Involving The Cervical Spine In Whom Life Expectancy Is Of Insufficient Duration To Permit Achievement Of 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 - NKG Posterior Cervical Screw System

All 95
Devices cleared under the same product code (NKG) and FDA review panel - the closest regulatory comparables to K231850.
Virage® OCT Spinal Fixation System
K250332 · Highridge Medical, LLC · Apr 2025
EUROPA™ Posterior Cervical Fusion System
K242516 · MiRus, LLC · Nov 2024
CarboClear® Posterior Cervical Screw System
K233989 · CarboFix Orthopedics , Ltd. · Mar 2024
Statera-C™ Spinal System
K233332 · K&J Consulting Corp. · Nov 2023
Posterior Cervical Spine System
K233078 · Double Medical Technology, Inc. · Nov 2023
SYMPHONY OCT System
K233366 · Medos International SARL · Nov 2023