Cleared Traditional

K182182 - YUKON OCT Spinal System (FDA 510(k) Clearance)

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

K182182 · K2m · Orthopedic device
Nov 2018
Decision
94d
Days
Class 2
Risk

K182182 is an FDA 510(k) clearance for the YUKON OCT Spinal System. Classified as Posterior Cervical Screw System (product code NKG), Class II - Special Controls.

Submitted by K2m (Leesburg, US). The FDA issued a Cleared decision on November 15, 2018 after a review of 94 days - within the typical 510(k) review window.

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.

Submission Details

510(k) Number K182182 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2018
Decision Date November 15, 2018
Days to Decision 94 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 116d · This submission: 94d
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 28
Devices cleared under the same product code (NKG) and FDA review panel - the closest regulatory comparables to K182182.
CarboClear® Posterior Cervical Screw System
K254045 · CarboFix Orthopedics , Ltd. · Mar 2026
Infinity™ OCT System
K254165 · Medtronic Sofamor Danek USA, Inc. · Jan 2026
CMORE® CT System
K252327 · Icotec AG · Nov 2025
Infinity™ OCT System
K253129 · Medtronic Sofamor Danek USA, Inc. · Oct 2025
ANAX™ OCT Spinal System
K251725 · Cg Medtech Co., Ltd. · Jun 2025
Sovereign Posterior Cervical System
K250866 · Met One Technologies, LLC · May 2025