Cleared Traditional

K170989 - Dymaxeon Spine System

K170989 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 49-day FDA review.

K170989 · Back 2 Basics Direct, LLC · Orthopedic device
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May 2017
Decision
49d
Days
Class 2
Risk

K170989 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 May 22, 2017 after a review of 49 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 Back 2 Basics Direct, LLC devices

Submission Details

510(k) Number K170989 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2017
Decision Date May 22, 2017
Days to Decision 49 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
73d faster than avg
Panel avg: 122d · This submission: 49d
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 K170989.
OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System
K171813 · L & K Biomed Co., Ltd. · Jul 2017
Palisade™ Pedicular Fixation System
K171438 · Spineology, Inc. · Jun 2017
M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws
K171170 · Medacta International S.A. · May 2017
Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory
K170496 · Stryker Corporation · May 2017
CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems
K170679 · Medtronic Sofamor Danek · May 2017
Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline Fixation Screw, Phoenix CDX MIS Spinal Fixation System, Firebird NXG Spinal Fixation System
K171082 · Orthofix, Inc. · May 2017