Cleared Special

DSS STABILIZATION SYSTEM (K113625) - FDA 510(k) Clearance

Class II Orthopedic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K113625 · Paradigm Spine, LLC · Orthopedic device
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Jan 2012
Decision
33d
Days
Class 2
Risk

K113625 is an FDA 510(k) clearance for the DSS STABILIZATION SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Paradigm Spine, LLC (Washington, US). The FDA issued a Cleared decision on January 10, 2012 after a review of 33 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Paradigm Spine, LLC devices

Submission Details

510(k) Number K113625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received December 08, 2011
Decision Date January 10, 2012
Days to Decision 33 days
Submission Type Special
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d faster than avg
Panel avg: 122d · This submission: 33d
Pathway characteristics
Modification to existing cleared device.

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 358
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K113625.
REVERE STABILIZATION SYSTEM
K122226 · Globus Medical, Inc. · Oct 2012
BEACON STABILIZATION SYSTEM
K121922 · Globus Medical, Inc. · Jul 2012
REVERE 4.5 STABILIZATION SYSTEM
K113395 · Globus Medical, Inc. · Jun 2012
REVOLVE ADDITIONAL IMPLANTS
K111449 · Globus Medical, Inc. · Aug 2011
REVERE CROSSTOP
K111479 · Globus Medical, Inc. · Aug 2011
REVLOK FENESTRATED SCREW SYSTEM
K110280 · Globus Medical, Inc. · Jul 2011