510(k) · Cleared
ClearedCenturion POCT System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthofix, Inc. · NKG Posterior Cervical Screw System
Cleared on Jan 22, 2018 as substantially equivalent to K150822 (Orthofix, Inc., 2015) after a 19-day review. Its family tree reaches back 4 generations to 1997. 6 later devices descend from it.
- Decided
- Jan 22, 2018
- Review
- 19 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. 6 later devices descend from it, 3 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 backK150822 Centurion POCT SystemOrthofix, Inc. · 2015
- This deviceK180025 Centurion POCT SystemOrthofix, Inc. · 2018
- Descendant · cites it directly · 3 of its ownK201481 Centurion POCT SystemOrthofix, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK211710 Ascent POCT System, Centurion POCT System, Spinal Fixation System…Orthofix, Inc. · 2021
- Descendant · 3 generations on · 1 of its ownK252088 Firebird SI Navigation SystemOrthofix US, LLC · 2025
- Descendant · 4 generations on · 0 of its ownK260571 SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK211993 Z-LINKPC SystemZavation Medical Products, LLC · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K201481Centurion POCT SystemOrthofix, Inc. · 2020 · cites it directly3descendants
- K211710Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS), Firebird Spinal…Orthofix, Inc. · 2021 · 2 generations on2descendants
- K252088Firebird SI Navigation SystemOrthofix US, LLC · 2025 · 3 generations on1descendant
- K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc. · 2026 · 4 generations on0descendants
- K211993Z-LINKPC SystemZavation Medical Products, LLC · 2021 · cites it directly0descendants
View 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 | K150822 | Centurion POCT System | Orthofix, Inc. | 2015 | — |
| 0 (this device) | K180025 | Centurion POCT System | Orthofix, Inc. | 2018 | — |
| +1 | K201481 | Centurion POCT System | Orthofix, Inc. | 2020 | — |
| +2 | K211710 | Ascent POCT System, Centurion POCT System, Spinal Fixation System (SFS)… | Orthofix, Inc. | 2021 | — |
| +3 | K252088 | Firebird SI Navigation System | Orthofix US, LLC | 2025 | — |
| +4 | K260571 | SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments | Life Spine, Inc. | 2026 | — |
| +1 | K211993 | Z-LINKPC System | Zavation Medical Products, LLC | 2021 | — |
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 |
|---|---|---|
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K150822 | Centurion POCT SystemSummary page 4…Product Code: KWP Regulatory Classification: Unclassified Review Panel: Orthopedic Device Panel Primary Predicate Device: K150822 – Centurion POCT System - Orthofix Reason for 510(k) Submission: Orthofix is submitting this Special 510(k) request for the foll… | 2015 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 21 years and passes through 4 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, K201481 (Orthofix, Inc., 2020) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K150822.
How does its category compare?
All NKG devicesNKG Posterior Cervical Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 Centurion POCT 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, 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…
Read the full statement (160 words)
The Centurion POCT 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, 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 Centurion POCT 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.
The Centurion POCT System can also be linked to the Orthofix Spinal Fixation System using the Axial or Parallel Rod Connector.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180025 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180025: Centurion POCT System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180025
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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