Cleared Special

K090740 - MODIFICATION TO: TSRH SPINAL SYSTEM

K090740 is the FDA 510(k) clearance for MODIFICATION TO: TSRH SPINAL SYSTEM by Medtronic Sofamor Danek. It is a Class 2 Orthopedic device (product code NKB) cleared through the Special 510(k) pathway after a 147-day FDA review.

K090740 · Medtronic Sofamor Danek · Orthopedic device
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Aug 2009
Decision
147d
Days
Class 2
Risk

K090740 is an FDA 510(k) clearance for the MODIFICATION TO: TSRH SPINAL SYSTEM. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Medtronic Sofamor Danek (Memphis, US). The FDA issued a Cleared decision on August 14, 2009 after a review of 147 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic Sofamor Danek devices

Submission Details

510(k) Number K090740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2009
Decision Date August 14, 2009
Days to Decision 147 days
Submission Type Special
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
25d slower than avg
Panel avg: 122d · This submission: 147d
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 668
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K090740.
MANTIS REDUX SPINAL SYSTEM
K092631 · Stryker Spine · Sep 2009
MODIFICATION TO BEACON STABILIZATION SYSTEM
K092610 · Globus Medical, Inc. · Sep 2009
MODIFICATION TO CD HORIZON SPINAL SYSTEM
K091974 · Medtronic Sofamor Danek USA, Inc. · Sep 2009
REVERE 6.35 STABILIZATION SYSTEM
K091782 · Globus Medical, Inc. · Aug 2009
5.5 HELICAL FLANGE SPINAL SYSTEM, POLARIS COMPONENTS
K090203 · Ebi, L.P. · Jul 2009
CONQUEST SPINAL SYSTEM
K090320 · Life Spine · Jul 2009