Cleared Traditional

K173508 - Everest Spinal System

K173508 is the FDA 510(k) clearance for Everest Spinal System by K2m. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K173508 · K2m · Orthopedic device
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Jan 2018
Decision
57d
Days
Class 2
Risk

K173508 is an FDA 510(k) clearance for the Everest Spinal System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by K2m (Leesburg, US). The FDA issued a Cleared decision on January 9, 2018 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3070 - 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 devices

Submission Details

510(k) Number K173508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2017
Decision Date January 09, 2018
Days to Decision 57 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
65d faster than avg
Panel avg: 122d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKB Thoracolumbosacral Pedicle Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3070
Definition Intended To Provide Immobilization And Stabilization Of Spinal Segments In Thoracic, Lumbar, And Sacral Spine As An Adjunct To 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 - NKB Thoracolumbosacral Pedicle Screw System

All 649
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K173508.
DeGen Medical E3 MIS Pedicle Screw System
K173814 · Degen Medical · Jan 2018
Wiltrom Spinal Fixation System
K172548 · Wiltrom Corporation Limited · Jan 2018
VERTICALE® Posterior Spinal Fixation System/VERTICALE® System
K171421 · Silony Medical GmbH · Jan 2018
Solanas® Posterior Stabilization System
K173522 · Alphatec Spine, Inc. · Nov 2017
VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with Fenestrations
K173095 · Medos International SARL · Oct 2017
XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory
K172724 · Stryker Corporation · Oct 2017