Cleared Special

K171438 - Palisade Pedicular Fixation System

K171438 is the FDA 510(k) clearance for Palisade Pedicular Fixation System by Spineology, Inc.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Special 510(k) pathway after a 17-day FDA review.

K171438 · Spineology, Inc. · Orthopedic device
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Jun 2017
Decision
17d
Days
Class 2
Risk

K171438 is an FDA 510(k) clearance for the Palisade™ Pedicular Fixation System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Spineology, Inc. (Saint Paul, US). The FDA issued a Cleared decision on June 2, 2017 after a review of 17 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 Spineology, Inc. devices

Submission Details

510(k) Number K171438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2017
Decision Date June 02, 2017
Days to Decision 17 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
105d faster than avg
Panel avg: 122d · This submission: 17d
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 K171438.
M.U.S.T. Combined Set Screws
K171758 · Medacta International S.A. · Aug 2017
TiLock2 Spinal System
K171838 · Genesys Spine · Jul 2017
OpenLoc-L Spinal Fixation System, LnK Spinal Fixation System
K171813 · L & K Biomed Co., Ltd. · Jul 2017
M.U.S.T. Pedicle Screw System Extension - Straight Connectors and Additional Screws
K171170 · Medacta International S.A. · May 2017
Xia® 3 Spinal System, Stryker Spine Power Adaptor Instrument Accessory
K170496 · Stryker Corporation · May 2017
CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems
K170679 · Medtronic Sofamor Danek · May 2017