Cleared Special

K090320 - CONQUEST SPINAL SYSTEM

K090320 is the FDA 510(k) clearance for CONQUEST SPINAL SYSTEM by Life Spine. It is a Class 2 Orthopedic device (product code NKB) cleared through the Special 510(k) pathway after a 163-day FDA review.

K090320 · Life Spine · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
163d
Days
Class 2
Risk

K090320 is an FDA 510(k) clearance for the CONQUEST 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 Life Spine (Hoffman Estates, US). The FDA issued a Cleared decision on July 22, 2009 after a review of 163 days - an extended review 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. 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.

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Submission Details

510(k) Number K090320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2009
Decision Date July 22, 2009
Days to Decision 163 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
41d slower than avg
Panel avg: 122d · This submission: 163d
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 K090320.
MODIFICATION TO: TSRH SPINAL SYSTEM
K090740 · Medtronic Sofamor Danek · Aug 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
NUVASIVE SPHERX II SYSTEM
K091502 · Nuvasive, Inc. · Jul 2009
CD HORIZON SPINAL SYSTEM
K091442 · Medtronic Sofamor Danek · Jul 2009
MODIFICATION TO: NUVASIVE SPHERX SYSTEM
K090981 · Nuvasive, Inc. · Jul 2009