Cleared Special

K173522 - Solanas Posterior Stabilization System

K173522 is the FDA 510(k) clearance for Solanas Posterior Stabilization System by Alphatec Spine, Inc.. It is a Class 2 Orthopedic device (product code NKB) cleared through the Special 510(k) pathway after a 16-day FDA review.

K173522 · Alphatec Spine, Inc. · Orthopedic device
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Nov 2017
Decision
16d
Days
Class 2
Risk

K173522 is an FDA 510(k) clearance for the Solanas® Posterior Stabilization System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Alphatec Spine, Inc. (Carlsnad, US). The FDA issued a Cleared decision on November 30, 2017 after a review of 16 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 Alphatec Spine, Inc. devices

Submission Details

510(k) Number K173522 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 2017
Decision Date November 30, 2017
Days to Decision 16 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
106d faster than avg
Panel avg: 122d · This submission: 16d
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 661
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K173522.
Wiltrom Spinal Fixation System
K172548 · Wiltrom Corporation Limited · Jan 2018
VERTICALE® Posterior Spinal Fixation System/VERTICALE® System
K171421 · Silony Medical GmbH · Jan 2018
Everest Spinal System
K173508 · K2m · Jan 2018
VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with Fenestrations
K173095 · Medos International SARL · Oct 2017
XIA® 4.5 Spinal System, Power Adaptor Instrument Accessory
K172724 · Stryker Corporation · Oct 2017
NuVasive® Precept™ Spinal System
K171894 · Nu Vasive, Incorporated · Sep 2017