Cleared Special

XIA 3 SPINAL SYSTEM, UNIPLANNER/REDUCTION SCREWS & VITALLIUM ROD (K091291) - FDA 510(k) Clearance

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

K091291 · Stryker Spine · Orthopedic device
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Jun 2009
Decision
54d
Days
Class 2
Risk

K091291 is an FDA 510(k) clearance for the XIA 3 SPINAL SYSTEM, UNIPLANNER/REDUCTION SCREWS & VITALLIUM ROD. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Stryker Spine (Allendale, US). The FDA issued a Cleared decision on June 24, 2009 after a review of 54 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 Stryker Spine devices

Submission Details

510(k) Number K091291 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2009
Decision Date June 24, 2009
Days to Decision 54 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
68d faster than avg
Panel avg: 122d · This submission: 54d
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 438
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K091291.
MODIFICATION TO: TSRH SPINAL SYSTEM
K090740 · Medtronic Sofamor Danek · Aug 2009
REVERE 6.35 STABILIZATION SYSTEM
K091782 · Globus Medical, Inc. · Aug 2009
CD HORIZON SPINAL SYSTEM
K091442 · Medtronic Sofamor Danek · Jul 2009
CD HORIZON SPINAL SYSTEM
K090390 · Medtronic Sofamor Danek · May 2009
REVOLVE STABILIZATION SYSTEM
K083416 · Globus Medical, Inc. · Jan 2009
TSRH SPINAL SYSTEM
K081080 · Medtronic Sofamor Danek · Nov 2008