510(k) Report

510(k) · Cleared

Cleared

Sovereign Posterior Cervical System

K250866510(k) TraditionalCleared May 20, 202557-day reviewClass II21 CFR 888.3075

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Met One Technologies, LLC · NKG Posterior Cervical Screw System

Cleared on May 20, 2025 as substantially equivalent to K131833 (Orthofix, Inc., 2014) and 4 other predicates after a 57-day review. Its family tree reaches back 16 generations to 2001. 1 later device descends from it.

Decided
May 20, 2025
Review
57 days
Class
Class II
Product code
NKG
Recalls
None
Predicates
5

Its longest line of descent runs back 16 generations to K003155 (2001). 184 ancestors in all, the oldest K841189 (1984). 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2020: 1 other ancestor2017: 2 other ancestors2015: 2 other ancestors2012: 1 other ancestor2011: 2 other ancestors2009: 6 other ancestors2008: 11 other ancestors2003: 12 other ancestors2000: 11 other ancestors2007: 5 other ancestors2004: 25 other ancestors2002: 15 other ancestors1997: 6 other ancestors2010: 1 other ancestor2006: 8 other ancestors2001: 10 other ancestors1999: 7 other ancestors1998: 7 other ancestors1995: 4 other ancestors2005: 15 other ancestors1985: 1 other ancestor1996: 4 other ancestors1994: 2 other ancestors1993: 2 other ancestors1992: 5 other ancestors1990: 2 other ancestors1984: 1 other ancestor2026: 1 descendant clearedK003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001K012254 · VBR · Osteotech, Inc. · 2001×3: 3 generations cleared close together, K021791 (2002), K023570 (2002), K030601 (2003) ×2: 2 generations cleared close together, K040536 (2004), K041556 (2004) K043561 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004×3: 3 generations cleared close together, K060719 (2006), K061938 (2006), K062427 (2006) K070742 · Modification to Vertex Reconstruction System · Medtronic Sofamor Danek · 2007K110522 · Vertex Reconstruction System, Vertex Select Reconstruction System · Medtronic Sofamor Danek USA, Inc. · 2011×2: 2 generations cleared close together, K113593 (2012), K122378 (2012) K131833 · Centurion Poct System · Orthofix, Inc. · 201419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 4 other ancestors2 generations back: 7 other ancestors3 generations back: 9 other ancestors4 generations back: 36 other ancestors5 generations back: 31 other ancestors6 generations back: 30 other ancestors7 generations back: 29 other ancestors8 generations back: 11 other ancestors9 generations back: 10 other ancestors10 generations back: 1 other ancestor 1 generation forward: 1 descendant K131833 · Centurion Poct System · Orthofix, Inc. · 2014K122378 · Nextgen Altius Oct System · Biomet Spine (Aka Ebi, LLC) · 2012 · recalledK113593 · Nextgen Altius Oct System · Biomet Spine (Aka Ebi, LLC) · 2012K110522 · Vertex Reconstruction System, Vertex Select Reconstruction System · Medtronic Sofamor Danek USA, Inc. · 2011K070742 · Modification to Vertex Reconstruction System · Medtronic Sofamor Danek · 2007K062427 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2006K061938 · Verte-Stack Spinal System · Medtronic Sofamor Danek, Inc. · 2006K060719 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2006K043561 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K041556 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K040536 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K030601 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2003K023570 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K021791 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K012254 · VBR · Osteotech, Inc. · 2001K003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001−15−10−50
  1. Root · 16 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 12 generations between
  3. 3 generations backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
  4. 2 generations backK122378 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012 · Recalled
  5. 1 generation backK131833 Centurion Poct SystemOrthofix, Inc. · 2014
  6. This deviceK250866 Sovereign Posterior Cervical SystemMet One Technologies, LLC · 2025
  7. Descendant · cites it directly · 0 of its ownK254260 The VEGA Cervical Screw SystemGS Medical Co., Ltd. · 2026
Show all 16 generations
  1. Root · 16 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 15 generations backK012254 VBROsteotech, Inc. · 2001
  3. 14 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 13 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 12 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 11 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  7. 10 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  8. 9 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  9. 8 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  10. 7 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
  11. 6 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  12. 5 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
  13. 4 generations backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
  14. 3 generations backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
  15. 2 generations backK122378 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012 · Recalled
  16. 1 generation backK131833 Centurion Poct SystemOrthofix, Inc. · 2014
  17. This deviceK250866 Sovereign Posterior Cervical SystemMet One Technologies, LLC · 2025

Most influential descendants

Showing 1 of 1 · See all
  • K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−16K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−15K012254VBROsteotech, Inc.2001—
−14K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−13K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−12K030601Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−11K040536Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−10K041556Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−9K043561Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−8K060719Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
−7K061938Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2006—
−6K062427Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
−5K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007—
−4K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011—
−3K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012—
−2K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)20121
−1K131833Centurion Poct SystemOrthofix, Inc.2014—
0 (this device)K250866Sovereign Posterior Cervical SystemMet One Technologies, LLC2025—
+1K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198510
199020
199250
199320
199420
199540
199640
199760
199870
199970
2000110
2001100
2002150
2003120
2004250
2005150
200680
200750
2008110
200960
201010
201120
201210
201520
201720
202010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202610
FIG. 1 — Lineage of K250866, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K252327 CMORE® CT System; CMORE® CT System Navigated…score 19.6 · 22 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (5)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K131833Centurion Poct System
Summary page 5
…888.3075 Product Code(s) NKG | Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K131833 Centurion POCT System NKG K162575 Z-LINKPC System NKG K142838 Synapse Occipital-Cervical-Thoracic (OCT) System NKG K192013 VERTIC…
Orthofix, Inc.2014—
*K162575Z-LINKPC System
Summary page 5
…egally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K131833 Centurion POCT System NKG K162575 Z-LINKPC System NKG K142838 Synapse Occipital-Cervical-Thoracic (OCT) System NKG K192013 VERTICALE Cervical System NKG K170108 Xu…
Zavation, LLC2017—
*K142838Synapse Occipital-Cervical-Thoracic (OCT) System
Summary page 5
…vices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K131833 Centurion POCT System NKG K162575 Z-LINKPC System NKG K142838 Synapse Occipital-Cervical-Thoracic (OCT) System NKG K192013 VERTICALE Cervical System NKG K170108 Xultan 5.5 Pedicle Screw Syste…
Synthes USA Products, LLC20151
*K192013VERTICALE® Cervical System
Summary page 5
…rimary Predicate is listed first) Product Code K131833 Centurion POCT System NKG K162575 Z-LINKPC System NKG K142838 Synapse Occipital-Cervical-Thoracic (OCT) System NKG K192013 VERTICALE Cervical System NKG K170108 Xultan 5.5 Pedicle Screw System NKB Device Description Summary 21 CFR 807.92(a)(4) The Met…
Silony Medical GmbH2020—
*K170108Xultan 5.5 Pedicle Screw System
Summary page 5
…uct Code K131833 Centurion POCT System NKG K162575 Z-LINKPC System NKG K142838 Synapse Occipital-Cervical-Thoracic (OCT) System NKG K192013 VERTICALE Cervical System NKG K170108 Xultan 5.5 Pedicle Screw System NKB Device Description Summary 21 CFR 807.92(a)(4) The Met One Technologies Sovereign Posterior…
Met One Technologies2017—

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd.20260

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 24 years and passes through 7 companies; a new generation was cleared every 10 months on median.
  • 18 of the 184 ancestors have a recall of any class.
  • Of its descendants, K254260 (GS Medical Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.

How does its category compare?

All NKG devices

NKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

FDA decisions per year · NKG

6in 2025

2015: 172016: 162017: 152018: 122019: 82020: 142021: 72022: 72023: 102024: 32025: 62026 (partial year): 4
2007high 17 (2015) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NKG

58in 2025

2015: 71 days median2016: 87 days median2017: 108 days median2018: 61 days median2019: 50 days median2020: 59 days median2021: 56 days median2022: 108 days median2023: 58 days median2024: 100 days median2025: 58 days median2026 (partial year): 169 days median
2007high 169 (2026) · low 50 (2019)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NKG

2in 2020

2018: 12019: 12020: 2
2007high 2 (2020) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NKG

153in 2025

2015: 42016: 732017: 992018: 1272019: 2142020: 2362021: 7042022: 1752023: 1312024: 2062025: 153
2007high 704 (2021) · low 0 (2007)2025

MAUDE reports naming product code NKG, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
2015177104
20161687073
201715108099
201812611127
20198501214
202014592236
20217560704
202271080175
202310580131
202431000206
20256580153
202641690—

What is it indicated for?

The Sovereign Posterior 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 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; and degenerative disease…

Read the full statement (182 words)

The Sovereign Posterior 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 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; 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 Sovereign Posterior Cervical 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 Sovereign Posterior Cervical System may be connected to the Xultan 5.5 system using rod-to-rod connectors or transition rods. Please refer to the individual system’s Instructions for Use for a list of indications for use 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.

More from Met One Technologies, LLC

4 FDA decisions under this applicant name. See the company

  • K251732Wrist Fracture SystemMet One Technologies, LLC · 2026
  • K230851Kodiak Lumbar Spacer SystemMet One Technologies, LLC · 2023
  • K222806Kodiak C Spinal Implant SystemMet One Technologies, LLC · 2022

Recent decisions in NKG

The NKG category page

  • K254260The VEGA Cervical Screw SystemGS Medical Co., Ltd. · 2026
  • K253195TAURUS Posterior Occipital-Cervico-Thoracic Spinal SystemsZheJiang Decans Medical Devices Co., Ltd. · 2026
  • K254045CarboClear® Posterior Cervical Screw System; CarboClear® Hybrid Posterior Cervical Screw SystemCarboFix Orthopedics, Ltd. · 2026
  • K254165Infinity™ OCT SystemMedtronic Sofamor Danek USA, Inc. · 2026
  • K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsIcotec AG · 2025

https://510kreport.com/device/K250866 · printed Nov 6, 2026

Cite this page

510(k) Report. “K250866: Sovereign Posterior 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/K250866

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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