Cleared Special

K161694 - Threshold™ Pedicular Fixation System

K161694 is an FDA 510(k) clearance for Threshold Pedicular Fixation System, manufactured by Spineology, Inc.. The device is a Class 2 Orthopedic device with product code NKB cleared through the Special 510(k) pathway after a 25-day FDA review.

K161694 · Spineology, Inc. · Orthopedic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
25d
Days
Class 2
Risk

K161694 is an FDA 510(k) clearance for the 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. (Saint Paul, US). The FDA issued a Cleared decision on July 15, 2016 after a review of 25 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.

FDA 510(k) Submission Details - K161694

510(k) Number K161694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2016
Decision Date July 15, 2016
Days to Decision 25 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
97d faster than avg
Panel avg: 122d · This submission: 25d
Pathway characteristics
Modification to existing cleared device.

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 914
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K161694.
VertiForm Posterior Fixation System
K161499 · Next Orthosurgical · Jul 2016
PASS LP Spinal System
K161627 · Medicrea International SA · Jul 2016
EVEREST Spinal System
K161369 · K2m, Incorporated · Jul 2016
Savannah-T® Pedicle Screw System
K152920 · Amendia, Inc. · Jul 2016
CorticaLINK Spinal Fusion Platform
K160722 · Facetlink Dba Linkspine · Jul 2016
Expedium Spine System, VIPER and VIPER 2 Systems
K160904 · Medos International SARL · Jul 2016
K161694 · Threshold™ Pedicular Fixation System
Download PDF FDA Summary Spineology, Inc.