510(k) · Cleared
ClearedPoseidon ST
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Signus Medinzintechnik GmbH · MQP Spinal Vertebral Body Replacement Device
Cleared on Jul 10, 2026 as substantially equivalent to K142205 (Nuvasive, Inc., 2015) after a 102-day review. Its family tree reaches back 5 generations to 1984.
- Decided
- Jul 10, 2026
- Review
- 102 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K841189 (1984). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 4 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 3 generations backK003836 Synthes Synex Spacer SystemSynthes · 2001 · Recalled
- 2 generations backK061891 Synex IISynthes Spine Co.Lp · 2006
- 1 generation backK142205 NuVasive X-CORE (R) Expandable VBR SystemNuvasive, Inc. · 2015
- This deviceK261031 Poseidon STSignus Medinzintechnik GmbH · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −4 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −3 | K003836 | Synthes Synex Spacer System | Synthes | 2001 | 11 |
| −2 | K061891 | Synex II | Synthes Spine Co.Lp | 2006 | — |
| −1 | K142205 | NuVasive X-CORE (R) Expandable VBR System | Nuvasive, Inc. | 2015 | — |
| 0 (this device) | K261031 | Poseidon ST | Signus Medinzintechnik GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2009 | 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 MQP? 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 MQP device
- #1 K261810 Vertiwedge® Intraosseous Systemscore 18.1 · 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 |
|---|---|---|---|
| * | K142205 | NuVasive X-CORE (R) Expandable VBR SystemSummary page 5…3060 Classification Name and Product Spinal intervertebral body fixation orthosis; MQP Codes: Legally Marketed Predicate Nuvasive X-Core Expandable VBR System (K142205) Device: (Primary Predicate) (Reference Predicate) SACRONAILÒ Transsacral System (K212755) (Reference Predicate)… | 2015 |
| † | K212755 | SIGNUS SACRONAIL® Transsacral Stabilization System | 2022 |
| † | K151704 | Diplomat® Spinal System | 2016 |
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 42 years and passes through 6 companies; a new generation was cleared every 8.5 years on median.
- 2 of the 10 ancestors have a recall of any class.
- 7 other devices also cite its predicate K142205.
How does its category compare?
All MQP devicesMQP Spinal Vertebral Body Replacement Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · MQP
4in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · MQP
187in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQP
1in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQP
168in 2025
MAUDE reports naming product code MQP, 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 | 30 | 107 | 2 | 61 |
| 2008 | 17 | 47 | 0 | 76 |
| 2009 | 11 | 115 | 14 | 111 |
| 2010 | 6 | 174 | 2 | 166 |
| 2011 | 8 | 237 | 1 | 121 |
| 2012 | 7 | 82 | 2 | 141 |
| 2013 | 3 | 90 | 0 | 207 |
| 2014 | 5 | 125 | 0 | 216 |
| 2015 | 8 | 126 | 0 | 258 |
| 2016 | 0 | — | 0 | 129 |
| 2017 | 9 | 97 | 0 | 141 |
| 2018 | 6 | 152 | 0 | 130 |
| 2019 | 8 | 93 | 0 | 117 |
| 2020 | 3 | 103 | 15 | 157 |
| 2021 | 0 | — | 0 | 208 |
| 2022 | 1 | — | 1 | 137 |
| 2023 | 1 | — | 0 | 71 |
| 2024 | 4 | 187 | 0 | 98 |
| 2025 | 0 | — | 0 | 168 |
| 2026 | 3 | 102 | 0 | — |
What is it indicated for?
The POSEIDON ST is used to maintain disc space distraction and structural stability until fusion occurs in skeletally mature adults requiring thoracic/lumbar interbody replacement. POSEIDON ST is indicated for use following complete or incomplete corpectomy due to destructive damage of the vertebral body, such as that caused by tumors, fractures, or osteomyelitis, in the thoracic and lumbar regions of the spine (TH1-L5). The access is posterior, lateral…
Read the full statement (170 words)
The POSEIDON ST is used to maintain disc space distraction and structural stability until fusion occurs in skeletally mature adults requiring thoracic/lumbar interbody replacement.
POSEIDON ST is indicated for use following complete or incomplete corpectomy due to destructive damage of the vertebral body, such as that caused by tumors, fractures, or osteomyelitis, in the thoracic and lumbar regions of the spine (TH1-L5). The access is posterior, lateral, anterolateral or anterior depending on the indication. The interior of the spacers can be packed with autograft or allogenic bone graft comprising cancellous and/or corticocancellous bone graft and/or demineralized allograft bone with bone marrow aspirate as an adjunct to fusion.
This device is intended to be used with FDA-cleared supplemental spinal fixation systems that have been labeled for use in the thoracic, and/or lumbar spine (i.e., posterior screw and rod systems, anterior plate systems, and anterior screw and rod systems). When used at more than two levels, supplemental fixation should include posterior fixation.
The device is intended for use in skeletally mature patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261031 · printed Nov 4, 2026
Cite this page
510(k) Report. “K261031: Poseidon ST.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K261031
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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