Cleared Special

K200666 - Stryker Xia 3 Power Adaptor

K200666 is the FDA 510(k) clearance for Stryker Xia 3 Power Adaptor by Stryker Spine. It is a Class 2 Orthopedic device (product code NKB) cleared through the Special 510(k) pathway after a 41-day FDA review.

K200666 · Stryker Spine · Orthopedic device
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Apr 2020
Decision
41d
Days
Class 2
Risk

K200666 is an FDA 510(k) clearance for the Stryker Xia 3 Power Adaptor. 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 April 23, 2020 after a review of 41 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 K200666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2020
Decision Date April 23, 2020
Days to Decision 41 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
81d faster than avg
Panel avg: 122d · This submission: 41d
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 649
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K200666.
CarboClear® II Pedicle Screw System
K200519 · CarboFix Orthopedics , Ltd. · Apr 2020
EXPEDIUM® Spine System
K200245 · Medos International S?rl · Apr 2020
ARx Spinal System
K200070 · Life Spine, Inc. · Apr 2020
RESPONSE™ Spine System, RESPONSE™ 4.5/5.0 Spine System, RESPONSE™ 5.5/6.0 Spine System
K193100 · OrthoPediatrics Corp. · Mar 2020
Nano FortiFix® System
K193211 · Nanovis Spine, LLC · Mar 2020
MEGAFIX® Pedicle Screw Spinal System
K191655 · Seohancare Co., Ltd. · Mar 2020