Cleared Traditional

K153370 - Caspian OCT/MESA Mini/DENALI Mini Spina...

K153370 is an FDA 510(k) clearance for Caspian OCT/MESA Mini/DENALI Mini Spina..., manufactured by K2m, Incorporated. The device is a Class 2 Orthopedic device with product code NKG cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K153370 · K2m, Incorporated · Orthopedic device
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Feb 2016
Decision
85d
Days
Class 2
Risk

K153370 is an FDA 510(k) clearance for the Caspian OCT/MESA Mini/DENALI Mini Spinal System. Classified as Posterior Cervical Screw System (product code NKG), Class II - Special Controls.

Submitted by K2m, Incorporated (Leesburg, US). The FDA issued a Cleared decision on February 16, 2016 after a review of 85 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all K2m, Incorporated devices

FDA 510(k) Submission Details - K153370

510(k) Number K153370 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 23, 2015
Decision Date February 16, 2016
Days to Decision 85 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 122d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NKG Device Classification - Class 2, Special Controls

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 109
Devices cleared under the same product code (NKG) and FDA review panel - the closest regulatory comparables to K153370.
Gibralt® Spine System and Gibralt® Occipital Spine System
K160697 · Exactech, Inc. · Jun 2016
Certex Spinal Fixation System
K160428 · X-Spine Systems, Inc. · May 2016
PASS OCT Spinal System
K160756 · Medicrea International SA · Apr 2016
Zimmer Virage OCT Spinal Fixation System
K153631 · Zimmer Spine, Inc. · Feb 2016
Perla Posterior Cervico-Thoracic Fixation system
K153386 · Spineart · Jan 2016
VuePoint OCT System
K153336 · Nu Vasive, Incorporated · Jan 2016