Cleared Traditional

VERTICALE® Cervical System (K192013) - FDA 510(k) Clearance

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

K192013 · Silony Medical GmbH · Orthopedic device
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Apr 2020
Decision
253d
Days
Class 2
Risk

K192013 is an FDA 510(k) clearance for the VERTICALE® Cervical System. Classified as Posterior Cervical Screw System (product code NKG), Class II - Special Controls.

Submitted by Silony Medical GmbH (Leinfelden-Echterdingen, DE). The FDA issued a Cleared decision on April 7, 2020 after a review of 253 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3075 - 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 K192013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2019
Decision Date April 07, 2020
Days to Decision 253 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
131d slower than avg
Panel avg: 122d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NKG Posterior Cervical Screw System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3075
Definition Posterior Cervical Screw Systems Are Intended For Use In Fusion Procedures Of The Cervical Spine And/or Craniocervical Junction And/or Cervicothoracic Junction For: 1) Spinal Fractures And Dislocations; 2) Deformities; 3) Instabilities; 4) Failed Previous Fusions; 5) Tumors; 6) Inflammatory Disorders; 7) Spinal Degeneration, 8) Facet Degeneration With Instability; And 9) Reconstruction Following Decompression To Treat Radiculopathy And/or Myelopathy. These Systems Are Also Intended To Stabilize The Spine In The Absence Of Fusion For A Limited Time Period In Patients With Tumors Involving The Cervical Spine In Whom Life Expectancy Is Of Insufficient Duration To Permit Achievement Of 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 - NKG Posterior Cervical Screw System

All 81
Devices cleared under the same product code (NKG) and FDA review panel - the closest regulatory comparables to K192013.
PERLA® Posterior Occipito-Cervico-Thoracic Fixation System
K200571 · Spineart · May 2020
Tiger® Occipital-Cervical-Thoracic Spinal Fixation System
K200863 · Corelink, LLC · Apr 2020
Solstice CCI
K200896 · Life Spine, Inc. · Apr 2020
SYMPHONY™ OCT System
K192646 · Medos International SARL · Apr 2020
NorthStar™ OCT Spinal System
K193615 · SeaSpine Orthopedics Corporation · Mar 2020
M.U.S.T. MINI Posterior Cervical Screws System
K200130 · Medacta International S.A. · Feb 2020