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. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Jan 30, 2014 as substantially equivalent to K030197 (Blackstone Medical, Inc., 2003) and 3 other predicates after a 224-day review. Its family tree reaches back 15 generations to 2001. 2 later devices descend from it.
- Decided
- Jan 30, 2014
- Review
- 224 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 15 generations to K003155 (2001). 157 ancestors in all, the oldest K841189 (1984). 2 later devices descend from it, 1 citing it directly.
- Root · 15 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 11 generations between
- 3 generations backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 2 generations backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
- 1 generation backK122378 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012 · Recalled
- This deviceK131833 Centurion Poct SystemOrthofix, Inc. · 2014
- 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
Show all 15 generations
- Root · 15 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 14 generations backK012254 VBROsteotech, Inc. · 2001
- 13 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 12 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 11 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 10 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 9 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 8 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 7 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 6 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
- 5 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 4 generations backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
- 3 generations backK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
- 2 generations backK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
- 1 generation backK122378 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012 · Recalled
- This deviceK131833 Centurion Poct SystemOrthofix, Inc. · 2014
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 |
|---|---|---|---|---|---|
| −15 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −14 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −13 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −12 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −11 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −10 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −9 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −8 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −7 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −6 | K061938 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2006 | — |
| −5 | K062427 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −4 | K070742 | Modification to Vertex Reconstruction System | Medtronic Sofamor Danek | 2007 | — |
| −3 | K110522 | Vertex Reconstruction System, Vertex Select Reconstruction System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| −2 | K113593 | Nextgen Altius Oct System | Biomet Spine (Aka Ebi, LLC) | 2012 | — |
| −1 | K122378 | Nextgen Altius Oct System | Biomet Spine (Aka Ebi, LLC) | 2012 | 1 |
| 0 (this device) | K131833 | Centurion Poct System | Orthofix, Inc. | 2014 | — |
| +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 |
|---|---|---|
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 2 | 0 |
| 1992 | 5 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 7 | 0 |
| 1999 | 7 | 0 |
| 2000 | 9 | 0 |
| 2001 | 8 | 0 |
| 2002 | 14 | 0 |
| 2003 | 11 | 0 |
| 2004 | 24 | 0 |
| 2005 | 12 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 0 |
| 2008 | 10 | 0 |
| 2009 | 5 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 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 KWP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K030197 | Blackstone Posterior Cervical SystemSummary page 1…ct Code: KWP Classification: Class 11 -21 CFR §888.3050 - Spinal Interlaminal Fixation Orthosis Predicate Device: Ascent POCT System (K030 197) Ascent POCT System (K I 11183)' Synthes Synapse 4.0mm System (K09 16… | 2003 |
| * | K111183 | Ascent Posterior Occipital Thoracic (Poct) System (Titanium & Cobalt Chrome Rods) | 2011 |
| * | K091689 | Synapse System 4.0MM, OC Fusion System 4.0MMSummary page 1…ate Device: Ascent POCT System (K030 197) Ascent POCT System (K I 11183)' Synthes Synapse 4.0mm System (K09 1689) Biomet Spine Nextgen Altius OCT System (K122378) Device Description: The Centurion POCT… | 2009 |
| * | K122378 | Nextgen Altius Oct SystemSummary page 1…cent POCT System (K I 11183)' Synthes Synapse 4.0mm System (K09 1689) Biomet Spine Nextgen Altius OCT System (K122378) Device Description: The Centurion POCT System is a temporary, multiple component system c… | 2012 |
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 13 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 12 of the 157 ancestors have a recall of any class.
- Of its descendants, K250866 (Met One Technologies, LLC, 2025) has gone furthest, with 1 descendant of its own.
- 11 other devices also cite its predicate K030197.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the Centurion POCT System is indicated for the following: a) degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies); b) spondylolisthesis; c) spinal stenosis; d) trauma (i.e., fracture or dislocation); e) atlanta-axial fracture with instability; f)…
Read the full statement (189 words)
When intended to promote fusion of the cervical spine and occipito-cervico-thoracic junction (Occiput - T3), the Centurion POCT System is indicated for the following:
a) degenerative disc disease (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies);
b) spondylolisthesis;
c) spinal stenosis;
d) trauma (i.e., fracture or dislocation);
e) atlanta-axial fracture with instability;
f) occipito-cervical dislocation;
g) tumors;
h) revision of previous cervical spine surgery;
The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the upper thoracic spine (TI - T3) for anchoring of the OCT construct only. They are not intended to be placed in the cervical spine. The lateral offset adapter is indicated for use in the upper thoracic spine (TI - T3). The hooks are intended to be placed from CI to T3. The cable (titanium) system to be used with the Centurion POCT System allows for wiretcable attachment to the posterior cervical spine.
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/K131833 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131833: Centurion Poct System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K131833
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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