Cleared Special

K180025 - Centurion POCT System

K180025 is the FDA 510(k) clearance for Centurion POCT System by Orthofix, Inc.. It is a Class 2 Orthopedic device (product code NKG) cleared through the Special 510(k) pathway after a 19-day FDA review.

K180025 · Orthofix, Inc. · Orthopedic device
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Jan 2018
Decision
19d
Days
Class 2
Risk

K180025 is an FDA 510(k) clearance for the Centurion POCT System. Classified as Posterior Cervical Screw System (product code NKG), Class II - Special Controls.

Submitted by Orthofix, Inc. (Lewisville, US). The FDA issued a Cleared decision on January 22, 2018 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3075 - 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 Orthofix, Inc. devices

Submission Details

510(k) Number K180025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2018
Decision Date January 22, 2018
Days to Decision 19 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
103d faster than avg
Panel avg: 122d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

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 96
Devices cleared under the same product code (NKG) and FDA review panel - the closest regulatory comparables to K180025.
Reform® POCT System
K172495 · Precision Spine, Inc. · Apr 2018
NuVasive® VuePoint® II OCT System
K180198 · Nu Vasive, Incorporated · Mar 2018
The Solstice OCT System
K173047 · Life Spine, Inc. · Feb 2018
Proficient® Posterior Cervical Spine System
K172594 · Spine Wave, Inc. · Dec 2017
INFINITY™ OCT System
K163375 · Medtronic Sofamor Danek USA, Inc. · Aug 2017
Connector System
K172194 · Orthofix, Inc. · Aug 2017