Cleared Special

K160980 - Threshold Pedicular Fixation System

K160980 is the FDA 510(k) clearance for Threshold 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 49-day FDA review.

K160980 · Spineology, Inc. · Orthopedic device
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May 2016
Decision
49d
Days
Class 2
Risk

K160980 is an FDA 510(k) clearance for the Threshold Pedicular Fixation System, 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 May 26, 2016 after a review of 49 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 K160980 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2016
Decision Date May 26, 2016
Days to Decision 49 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
73d faster than avg
Panel avg: 122d · This submission: 49d
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 K160980.
Arsenal Spinal Fixation System
K161363 · Alphatec Spine, Inc. · Jun 2016
NuVasive® Reline® System
K160989 · Nu Vasive, Incorporated · Jun 2016
Mariner Pedicle Screw System
K160902 · SeaSpine Orthopedics Corporation · May 2016
Response 5.5 Spine System
K160466 · OrthoPediatrics Corp. · Mar 2016
Palisade Pedicular Fixation System
K153323 · Spineology, Inc. · Feb 2016
CD HORIZON Spinal System, Medtronic Navigated Manual Reusable Instruments for Use with the STEALTHSTATION System, Medtronic Reusable Instruments for Use with the IPC POWEREASE System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION and IPC POWEREASE Systems
K153442 · Medtronic Sofamor Danek USA, Inc. · Feb 2016