Cleared Traditional

K182182 - YUKON OCT Spinal System

K182182 is the FDA 510(k) clearance for YUKON OCT Spinal System by K2m. It is a Class 2 Orthopedic device (product code NKG) cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K182182 · K2m · Orthopedic device
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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.

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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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 122d · 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 95
Devices cleared under the same product code (NKG) and FDA review panel - the closest regulatory comparables to K182182.
Perla® Posterior Cervico-Thoracic Fixation System
K190071 · Spineart · Feb 2019
M.U.S.T. Mini Extension
K182837 · Medacta International S.A. · Jan 2019
ANAX™ OCT Spinal System
K183383 · U&I Corporation · Dec 2018
Saxxony™ Posterior Cervical Thoracic System
K182508 · Nexxt Spine, LLC · Nov 2018
EVEREST Spinal System, RANGE (MESA and DENALI) Spinal System, CASPIAN OCT (MESA Mini and DENALI Mini) Spinal System, YUKON OCT Spinal System
K181603 · K2m, Inc. · Oct 2018
SYMPHONY™ OCT System
K181949 · Medos International SARL · Oct 2018