Cleared Traditional

K072426 - ATLAS SPINE PEDICLE SCREW SYSTEM

K072426 is an FDA 510(k) clearance for ATLAS SPINE PEDICLE SCREW SYSTEM, manufactured by Atlas Spine, LLC. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K072426 · Atlas Spine, LLC · Orthopedic device
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Oct 2007
Decision
51d
Days
Class 2
Risk

K072426 is an FDA 510(k) clearance for the ATLAS SPINE PEDICLE SCREW SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Atlas Spine, LLC (Jupiter, US). The FDA issued a Cleared decision on October 19, 2007 after a review of 51 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 Atlas Spine, LLC devices

FDA 510(k) Submission Details - K072426

510(k) Number K072426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2007
Decision Date October 19, 2007
Days to Decision 51 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
71d faster than avg
Panel avg: 122d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NKB Device Classification - Class 2, Special Controls

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 751
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K072426.
MANTIS SPINAL SYSTEM
K073151 · Stryker Corp. · Dec 2007
VALEO PEDICLE SCREW SPINAL SYSTEM
K072022 · Amedica Corp. · Nov 2007
INNOVASIS EXCELLA SPINAL SYSTEM, EXCELLA-M (MONOAXIAL SCREWS), EXCELLA-P (POLYAXIAL SCREWS)
K071921 · Innovasis, Inc. · Nov 2007
MERCURY SPINAL SYSTEM
K071914 · Spinal Elements, Inc. · Oct 2007
MODIFICATION TO TSRH SPINAL SYSTEM
K072429 · Medtronic Sofamor Danek · Sep 2007
EXPEDIUM SPINE SYSTEM
K070387 · Depuy Spine, Inc. · Sep 2007