510(k) · Cleared
ClearedDOMINION Expandable Corpectomy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Astura Medical · MQP Spinal Vertebral Body Replacement Device
Cleared on Mar 8, 2024 as substantially equivalent to K190426 (Astura Medical, LLC, 2019) after a 161-day review. Its family tree reaches back 17 generations to 1984. 2 later devices descend from it.
- Decided
- Mar 8, 2024
- Review
- 161 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K841189 (1984). 106 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations between
- 3 generations backK163491 NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2017
- 2 generations backK173324 ALTA Anterior Cervical Interbody SpacerAstura Medical · 2018
- 1 generation backK190426 ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC · 2019
- This deviceK233359 DOMINION Expandable Corpectomy SystemAstura Medical · 2024
- Descendant · cites it directly · 1 of its ownK241468 Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK261810 Vertiwedge® Intraosseous SystemFoundation Surgical Group · 2026
Show all 17 generations
- Root · 17 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 16 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 15 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 14 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 13 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 12 generations backK033109 Ellys and Aurys Vertebral Body ReplacementsScient'X · 2004
- 11 generations backK043479 MC+ Partial VBRLdr Spine USA · 2005
- 10 generations backK080728 LDR Spine Roi-C ImplantLdr Spine USA · 2008
- 9 generations backK083857 LDR Spine Roi-C ImplantLdr Spine USA · 2009
- 8 generations backK091088 LDR Spine Cervical Interbody Fusion SystemLdr Spine USA · 2009
- 7 generations backK123206 Maxim Surgical X-Treme Interbody Fusion SystemMaxim Surgical · 2013
- 6 generations backK140003 Coroent Small Interbody SystemNuvasive, Inc. · 2014
- 5 generations backK140921 Coroent Small Interbody SystemNu Vasive, Incorporated · 2014
- 4 generations backK150362 NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2015
- 3 generations backK163491 NuVasive CoRoent Small Interbody SystemNu Vasive, Incorporated · 2017
- 2 generations backK173324 ALTA Anterior Cervical Interbody SpacerAstura Medical · 2018
- 1 generation backK190426 ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC · 2019
- This deviceK233359 DOMINION Expandable Corpectomy SystemAstura Medical · 2024
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 |
|---|---|---|---|---|---|
| −17 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −16 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −15 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −14 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −13 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −12 | K033109 | Ellys and Aurys Vertebral Body Replacements | Scient'X | 2004 | — |
| −11 | K043479 | MC+ Partial VBR | Ldr Spine USA | 2005 | — |
| −10 | K080728 | LDR Spine Roi-C Implant | Ldr Spine USA | 2008 | — |
| −9 | K083857 | LDR Spine Roi-C Implant | Ldr Spine USA | 2009 | — |
| −8 | K091088 | LDR Spine Cervical Interbody Fusion System | Ldr Spine USA | 2009 | — |
| −7 | K123206 | Maxim Surgical X-Treme Interbody Fusion System | Maxim Surgical | 2013 | — |
| −6 | K140003 | Coroent Small Interbody System | Nuvasive, Inc. | 2014 | — |
| −5 | K140921 | Coroent Small Interbody System | Nu Vasive, Incorporated | 2014 | — |
| −4 | K150362 | NuVasive CoRoent Small Interbody System | Nu Vasive, Incorporated | 2015 | — |
| −3 | K163491 | NuVasive CoRoent Small Interbody System | Nu Vasive, Incorporated | 2017 | — |
| −2 | K173324 | ALTA Anterior Cervical Interbody Spacer | Astura Medical | 2018 | — |
| −1 | K190426 | ALTA Anterior Cervical Corpectomy System | Astura Medical, LLC | 2019 | — |
| 0 (this device) | K233359 | DOMINION Expandable Corpectomy System | Astura Medical | 2024 | — |
| +1 | K241468 | Vertiwedge® Intraosseous System | Foundation Surgical Group, Inc. | 2024 | — |
| +2 | K261810 | Vertiwedge® Intraosseous System | Foundation Surgical Group | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 7 | 0 |
| 2003 | 7 | 0 |
| 2004 | 16 | 0 |
| 2005 | 9 | 0 |
| 2006 | 4 | 0 |
| 2007 | 5 | 0 |
| 2008 | 9 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 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 |
|---|---|---|---|
| * | K190426 | ALTA Anterior Cervical Corpectomy SystemSummary page 4…, PLR CFR Section 21 CFR section 888.3060 Device Panel Orthopedic Primary Predicate Device ALTA Anterior Cervical Corpectomy Spacer (K190426) Reference Predicate DOLOMITE Anterior Cervical Stabilization System (K202065) Device(s) FORTIFY Corp… | 2019 |
| † | K202065 | DOLOMITE Anterior Cervical Stabilization System | 2020 |
| † | K173982 | FORTIFY Corpectomy Spacers | 2018 |
| † | K153446 | OLYMPIC Posterior Spinal Fixation System | 2016 |
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 |
|---|---|---|---|
| K241468 | Vertiwedge® Intraosseous System | 2024 | 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 40 years and passes through 11 companies; a new generation was cleared every 1.3 years on median.
- 11 of the 106 ancestors have a recall of any class.
- Of its descendants, K241468 (Foundation Surgical Group, Inc., 2024) has gone furthest, with 1 descendant of its own.
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. 2024, 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 DOMINION Expandable Corpectomy System is indicated for vertebral body replacement in the cervical spine (C2-T1) and the thoracolumbar spine (T1-L5). The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion. When used in the cervical spine (C2-T1), DOMINION spacers are intended for use in skeletally mature patients to replace a diseased or damaged…
Read the full statement (274 words)
The DOMINION Expandable Corpectomy System is indicated for vertebral body replacement in the cervical spine (C2-T1) and the thoracolumbar spine (T1-L5). The System is designed for use with autogenous and/or allogeneic bone graft comprised of cancellous and/or corticocancellous bone graft as an adjunct to fusion.
When used in the cervical spine (C2-T1), DOMINION spacers are intended for use in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor fracture or osteomyelitis, or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues in the cervical degenerative disorders. These spacers are 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, with bone graft used at the surgeon's discretion. The System is intended to be used with supplemental fixation that has been cleared by the FDA for use in the cervical spine.
When used in the thoracolumbar spine (T1-L5), DOMINION spacers are intended for use to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e. fracture). These spacers are designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.
The system is intended to be used with supplemental fixation that has been cleared by the FDA for use in the thoracolumbar 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233359 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233359: DOMINION Expandable Corpectomy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233359
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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