Cleared Traditional

K172107 - Threshold™ V2 Pedicular Fixation System, Threshold™ Pedicular Fixation System, Fortress™ Pedicular Fixation System, Palisade™ Pedicular Fixation System

K172107 is an FDA 510(k) clearance for Threshold V2 Pedicular Fixation System, manufactured by Spineology, Inc.. The device is a Class 2 Orthopedic device with product code NKB cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K172107 · Spineology, Inc. · Orthopedic device
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Aug 2017
Decision
40d
Days
Class 2
Risk

K172107 is an FDA 510(k) clearance for the Threshold™ V2 Pedicular Fixation System, Threshold™ 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. (St. Paul, US). The FDA issued a Cleared decision on August 21, 2017 after a review of 40 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Spineology, Inc. devices

FDA 510(k) Submission Details - K172107

510(k) Number K172107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2017
Decision Date August 21, 2017
Days to Decision 40 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
82d faster than avg
Panel avg: 122d · This submission: 40d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NKB Device Classification - Class 2, Special Controls

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 883
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K172107.
NEO Pedicle Screw System™
K171582 · Neo Medical SA · Sep 2017
Additional VIPER PRIME™ screws with fenestrations
K171570 · Medos International SARL · Aug 2017
Zenius™, lliad™ and Kora™ Spinal Fixation Systems
K171526 · Medyssey USA, Inc. · Aug 2017
CapSure® PS System
K172175 · Spine Wave, Inc. · Aug 2017
Paonan Armstrong Posterior Spinal Fixation System
K161225 · Paonan Biotech Co., Ltd. · Aug 2017
Premier
K170861 · Shandong Weigao Orthopaedic Device Co., Ltd. · Aug 2017