Cleared Traditional

K113666 - XIA 3 SPINAL SYSTEM

K113666 is the FDA 510(k) clearance for XIA 3 SPINAL SYSTEM by Stryker Spine. It is a Class 2 Orthopedic device (product code NKB) cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K113666 · Stryker Spine · Orthopedic device
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Aug 2012
Decision
259d
Days
Class 2
Risk

K113666 is an FDA 510(k) clearance for the XIA 3 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 Stryker Spine (Washington, US). The FDA issued a Cleared decision on August 28, 2012 after a review of 259 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Stryker Spine devices

Submission Details

510(k) Number K113666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received December 13, 2011
Decision Date August 28, 2012
Days to Decision 259 days
Submission Type Traditional
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
137d slower than avg
Panel avg: 122d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K113666.
REVERE STABILIZATION SYSTEM
K122226 · Globus Medical, Inc. · Oct 2012
CD HORIZON SPINAL SYSTEM
K122433 · Medtronic Sofamor Danek, Inc. · Sep 2012
NUVASIVE PRECEPT SPINAL SYSTEM
K122352 · Nuvasive, Inc. · Sep 2012
NUVASIVE POLYAXIAL SPINAL SCREWS
K121619 · Nuvasive, Inc. · Aug 2012
CD HORIZON SPINAL SYSTEM
K121764 · Medtronic Sofamor Danek, Inc. · Aug 2012
NAUTILUS SPINAL SYSTEM
K111953 · Life Spine · Aug 2012