Cleared Traditional

K150184 - Dymaxeon Spine System

K150184 is the FDA 510(k) clearance for Dymaxeon Spine System by Back 2 Basics Direct, LLC. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K150184 · Back 2 Basics Direct, LLC · Orthopedic device
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Jun 2015
Decision
139d
Days
Class 2
Risk

K150184 is an FDA 510(k) clearance for the Dymaxeon Spine System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Back 2 Basics Direct, LLC (Independence, US). The FDA issued a Cleared decision on June 15, 2015 after a review of 139 days - within the typical 510(k) review window.

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: 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 K150184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2015
Decision Date June 15, 2015
Days to Decision 139 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
17d slower than avg
Panel avg: 122d · This submission: 139d
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 650
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K150184.
Nautilus Spinal System
K151196 · Life Spine, Inc. · Jul 2015
Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System
K151488 · Orthofix, Inc. · Jul 2015
Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360º Spinal Fixatoin System, Title 2 Polyaxial Spinal System
K142752 · Zimmer Spine, Inc. · Jun 2015
Mercury Spinal System
K151215 · Spinal Elements, Inc. · Jun 2015
Response 5.5/6.0 Spine System
K150600 · OrthoPediatrics Corp. · May 2015
NuVasive Reline System
K143684 · Nu Vasive, Incorporated · Apr 2015