Cleared Special

K090408 - MODIFICATION TO: DSS STABILIZATION SYSTEM

K090408 is an FDA 510(k) clearance for MODIFICATION TO: DSS STABILIZATION SYSTEM, manufactured by Paradigm Spine, LLC. The device is a Class 2 Orthopedic device with product code NKB cleared through the Special 510(k) pathway after a 30-day FDA review.

K090408 · Paradigm Spine, LLC · Orthopedic device
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Mar 2009
Decision
30d
Days
Class 2
Risk

K090408 is an FDA 510(k) clearance for the MODIFICATION TO: 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 March 20, 2009 after a review of 30 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

FDA 510(k) Submission Details - K090408

510(k) Number K090408 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received February 18, 2009
Decision Date March 20, 2009
Days to Decision 30 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
92d faster than avg
Panel avg: 122d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 731
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K090408.
CD HORIZON SPINAL SYSTEM
K090390 · Medtronic Sofamor Danek · May 2009
MODIFICATION TO EXPEDIUM SPINE SYSTEM
K090799 · Depuy Spine, Inc. · Apr 2009
XIA 3 SPINAL SYSTEM
K083393 · Stryker Spine · Apr 2009
EXPEDIUM SPINE SYSTEM
K090230 · Depuy Spine, Inc. · Mar 2009
MERCURY SPINAL SYSTEM
K082353 · Spinal Elements, Inc. · Jan 2009
NEWPORT SPINAL SYSTEM
K083089 · Seaspine, Inc. · Jan 2009