Cleared Special

K201481 - Centurion POCT System

K201481 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 11-day FDA review.

K201481 · Orthofix, Inc. · Orthopedic device
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Jun 2020
Decision
11d
Days
Class 2
Risk

K201481 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 June 15, 2020 after a review of 11 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 K201481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2020
Decision Date June 15, 2020
Days to Decision 11 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
111d faster than avg
Panel avg: 122d · This submission: 11d
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 K201481.
Invictus™ OCT Spinal Fixation System
K203125 · Alphatec Spine, Inc. · Dec 2020
M.U.S.T. MINI Posterior Cervical Screws System
K203149 · Medacta International S.A. · Nov 2020
LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation System
K200793 · L & K Biomed Co., Ltd. · Oct 2020
Invictus™ CT Spinal Fixation System
K200936 · Alphatec Spine, Inc. · May 2020
PERLA® Posterior Occipito-Cervico-Thoracic Fixation System
K200571 · Spineart · May 2020
Tiger® Occipital-Cervical-Thoracic Spinal Fixation System
K200863 · Corelink, LLC · Apr 2020