Cleared Traditional

VERTICALE® Posterior Spinal Fixation System/VERTICALE® System (K171421) - FDA 510(k) Clearance

Class II Orthopedic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K171421 · Silony Medical GmbH · Orthopedic device
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Jan 2018
Decision
240d
Days
Class 2
Risk

K171421 is an FDA 510(k) clearance for the VERTICALE® Posterior Spinal Fixation System/VERTICALE® System. Classified as Thoracolumbosacral Pedicle Screw System within the NKB classification (a category for thoracolumbosacral pedicle screw systems), Class II - Special Controls.

Submitted by Silony Medical GmbH (Leinfelden-Echterdingen, DE). The FDA issued a Cleared decision on January 10, 2018 after a review of 240 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Silony Medical GmbH devices

Submission Details

510(k) Number K171421 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2017
Decision Date January 10, 2018
Days to Decision 240 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
118d slower than avg
Panel avg: 122d · This submission: 240d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Emergo Global Consulting, LLC
Indraj Bamrah

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NKB Thoracolumbosacral Pedicle Screw System

All 447
Devices cleared under the same product code (NKB) and FDA review panel - the closest regulatory comparables to K171421.
SeaSpine Mariner Pedicle Screw System
K173882 · SeaSpine Orthopedics Corporation · Feb 2018
DeGen Medical E3 MIS Pedicle Screw System
K173814 · Degen Medical · Jan 2018
Wiltrom Spinal Fixation System
K172548 · Wiltrom Corporation Limited · Jan 2018
Everest Spinal System
K173508 · K2m · Jan 2018
Solanas® Posterior Stabilization System
K173522 · Alphatec Spine, Inc. · Nov 2017
VIPER PRIME™ Screws, VIPER PRIME™ Screws with Fenestrations, EXPEDIUM® Verse Screws with Fenestrations
K173095 · Medos International SARL · Oct 2017