510(k) · Cleared
ClearedThe VEGA Cervical Screw System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
GS Medical Co., Ltd. · NKG Posterior Cervical Screw System
Cleared on Sep 17, 2026 as substantially equivalent to K250866 (Met One Technologies, LLC, 2025) after a 262-day review. Its family tree reaches back 17 generations to 2001.
- Decided
- Sep 17, 2026
- Review
- 262 days
- Class
- Class II
- Product code
- NKG
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K003155 (2001). 185 ancestors in all, the oldest K841189 (1984). No later device cites it as a predicate yet.
- Root · 17 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 13 generations between
- 3 generations backK122378 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012 · Recalled
- 2 generations backK131833 Centurion Poct SystemOrthofix, Inc. · 2014
- 1 generation backK250866 Sovereign Posterior Cervical SystemMet One Technologies, LLC · 2025
- This deviceK254260 The VEGA Cervical Screw SystemGS Medical Co., Ltd. · 2026
Show all 17 generations
- Root · 17 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 16 generations backK012254 VBROsteotech, Inc. · 2001
- 15 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 14 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 13 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 12 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 11 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 10 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 9 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 8 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
- 7 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 6 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
- 5 generations backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 4 generations backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
- 3 generations backK122378 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012 · Recalled
- 2 generations backK131833 Centurion Poct SystemOrthofix, Inc. · 2014
- 1 generation backK250866 Sovereign Posterior Cervical SystemMet One Technologies, LLC · 2025
- This deviceK254260 The VEGA Cervical Screw SystemGS Medical Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −16 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −15 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −14 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −13 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −12 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −11 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −10 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −9 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −8 | K061938 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2006 | — |
| −7 | K062427 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −6 | K070742 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | 2007 | — |
| −5 | K110522 | Vertex Reconstruction System, Vertex Select Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −4 | K113593 | Nextgen Altius Oct System | Biomet Spine (Aka Ebi, LLC) | 2012 | — |
| −3 | K122378 | Nextgen Altius Oct System | Biomet Spine (Aka Ebi, LLC) | 2012 | 1 |
| −2 | K131833 | Centurion Poct System | Orthofix, Inc. | 2014 | — |
| −1 | K250866 | Sovereign Posterior Cervical System | Met One Technologies, LLC | 2025 | — |
| 0 (this device) | K254260 | The VEGA Cervical Screw System | GS Medical Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 4 | 0 |
| 1997 | 6 | 0 |
| 1998 | 7 | 0 |
| 1999 | 7 | 0 |
| 2000 | 11 | 0 |
| 2001 | 10 | 0 |
| 2002 | 15 | 0 |
| 2003 | 12 | 0 |
| 2004 | 25 | 0 |
| 2005 | 15 | 0 |
| 2006 | 8 | 0 |
| 2007 | 5 | 0 |
| 2008 | 11 | 0 |
| 2009 | 6 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2020 | 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 |
|---|---|---|---|
| * | K250866 | Sovereign Posterior Cervical SystemSummary page 5…NKG 2.0 PREDICATE DEVICES Primary Predicate: Trade/Proprietary Name of Device: Sovereign Posterior Cervical System 510(k) number K250866 Common Or Usual Name: Posterior Cervical Screw System Classification Name: Posterior Cer… | 2025 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 18 of the 185 ancestors have a recall of any class.
How does its category compare?
All NKG devicesNKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 VEGA Cervical Screw System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the treatment of the following acute and chronic instabilities of the cervical spine (C1-C7) and the upper 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; and…
Read the full statement (185 words)
The VEGA Cervical Screw System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the treatment of the following acute and chronic instabilities of the cervical spine (C1-C7) and the upper 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; and 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.
The VEGA Cervical Screw System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.
In order to achieve additional levels of fixation, the VEGA Cervical Screw System may be connected to the AnyPlus Il Spinal Fixation System, using compatible connectors or transition rods. Please refer to the individual system’s Instructions for Use for a complete list of indications for each system.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K254260 · printed Nov 6, 2026
Cite this page
510(k) Report. “K254260: The VEGA Cervical Screw System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K254260
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026