Cleared Traditional

K150184 - Dymaxeon Spine System

K150184 is an FDA 510(k) clearance for Dymaxeon Spine System, manufactured by Back 2 Basics Direct, LLC. The device is a Class 2 Orthopedic device with 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.

View all Back 2 Basics Direct, LLC devices

FDA 510(k) Submission Details - K150184

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
Combination Product No
PCCP Authorized No
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.

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 Consultant

Musculoskeletal Clinical Regulatory Advisers, LLC
Samuel Pollard

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NKB Thoracolumbosacral Pedicle Screw System

All 874
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K150184.
Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System
K151488 · Orthofix, Inc. · Jul 2015
GALAXY MIS Screw System
K143110 · Bm Korea · Jun 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
Iliad Pedicle Screw System and Zenius Pedicle Screw System
K142835 · Medyssey USA, Inc. · Jun 2015
Mercury Spinal System
K151215 · Spinal Elements, Inc. · Jun 2015
APEX-DL Spine System
K143683 · Spinecraft, LLC · May 2015