510(k) · Cleared
ClearedVERTICALE® Cervical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Silony Medical GmbH · NKG Posterior Cervical Screw System
Cleared on Apr 7, 2020 as substantially equivalent to K151885 (Depuy Synthes, Inc., 2015) after a 253-day review. Its family tree reaches back 4 generations to 1997. 2 later devices descend from it.
- Decided
- Apr 7, 2020
- Review
- 253 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K953076 (1997). 5 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK953076 Townley Facet/Pedicular Screw Plating SystemSofamor Danek USA,Inc. · 1997
- 3 generations backK062254 Axis Fixation SystemMedtronic Sofamor Danek, Inc. · 2008
- 2 generations backK142838 Synapse Occipital-Cervical-Thoracic (OCT) SystemSynthes USA Products, LLC · 2015 · Recalled
- 1 generation backK151885 SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal SystemDepuy Synthes, Inc. · 2015
- This deviceK192013 VERTICALE® Cervical SystemSilony Medical GmbH · 2020
- Descendant · cites it directly · 1 of its ownK250866 Sovereign Posterior Cervical SystemMet One Technologies, LLC · 2025
- Descendant · 2 generations on · 0 of its ownK254260 The VEGA Cervical Screw SystemGS Medical Co., Ltd. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K953076 | Townley Facet/Pedicular Screw Plating System | Sofamor Danek USA,Inc. | 1997 | — |
| −3 | K062254 | Axis Fixation System | Medtronic Sofamor Danek, Inc. | 2008 | — |
| −2 | K142838 | Synapse Occipital-Cervical-Thoracic (OCT) System | Synthes USA Products, LLC | 2015 | 1 |
| −1 | K151885 | SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal System | Depuy Synthes, Inc. | 2015 | — |
| 0 (this device) | K192013 | VERTICALE® Cervical System | Silony Medical GmbH | 2020 | — |
| +1 | K250866 | Sovereign Posterior Cervical System | Met One Technologies, LLC | 2025 | — |
| +2 | K254260 | The VEGA Cervical Screw System | GS Medical Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NKG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NKG device
- #1 K252327 CMORE® CT System; CMORE® CT System Navigated…score 19.6 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K151885 | SUMMIT SI OCT Spinal Fixation System, MOUNTAINEER OCT Spinal SystemSummary page 4…evice Class: II Classification Panel: Orthopedic 5. Legally Marketed Primary Predicate Device Mountaineer OCT Spinal System; DePuy Spine, Inc.; K151885 K192013… | 2015 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250866 | Sovereign Posterior Cervical System | 2025 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 5 companies; a new generation was cleared every 6.6 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K250866 (Met One Technologies, LLC, 2025) has gone furthest, with 1 descendant of its own.
- 10 other devices also cite its predicate K151885.
How does its category compare?
All NKG devicesNKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · NKG
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKG
58in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKG
2in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NKG
153in 2025
MAUDE reports naming product code NKG, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 17 | 71 | 0 | 4 |
| 2016 | 16 | 87 | 0 | 73 |
| 2017 | 15 | 108 | 0 | 99 |
| 2018 | 12 | 61 | 1 | 127 |
| 2019 | 8 | 50 | 1 | 214 |
| 2020 | 14 | 59 | 2 | 236 |
| 2021 | 7 | 56 | 0 | 704 |
| 2022 | 7 | 108 | 0 | 175 |
| 2023 | 10 | 58 | 0 | 131 |
| 2024 | 3 | 100 | 0 | 206 |
| 2025 | 6 | 58 | 0 | 153 |
| 2026 | 4 | 169 | 0 | — |
What is it indicated for?
The VERTICALE Cervical System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the craniocervical junction (occiput-C2), the cervical spine (C1 to C7) and the thoracic spine (T1-T3):
- traumatic spinal fractures and /or traumatic dislocations
- instability or deformity
- failed previous fusions (e.g. pseudoarthrosis)
- tumors involving the cervical/thoracic spine
- degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and
- degenerative disease of the facets with instability
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192013 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192013: VERTICALE® Cervical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192013
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026