510(k) · Cleared
ClearedOmnia Medical VBR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omnia Medical, LLC · PLR Spinal Vertebral Body Replacement Device - Cervical
Cleared on Aug 28, 2019 as substantially equivalent to K180550 (Nu Vasive, Incorporated, 2018) and 1 other predicate after a 57-day review. Its family tree reaches back 14 generations to 2001. 5 later devices descend from it.
- Decided
- Aug 28, 2019
- Review
- 57 days
- Class
- Class II
- Product code
- PLR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K003155 (2001). 44 ancestors in all, the oldest K841189 (1984). 5 later devices descend from it, 3 citing it directly.
- Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 10 generations between
- 3 generations backK151167 NuVasive PEEK Corpectomy SystemNu Vasive, Incorporated · 2015
- 2 generations backK170271 NuVasive (r) Monolith Corpectomy SystemNu Vasive, Incorporated · 2017
- 1 generation backK180550 NuVasive Monolith Cervical Corpectomy SystemNu Vasive, Incorporated · 2018
- This deviceK191778 Omnia Medical VBROmnia Medical, LLC · 2019
- Descendant · cites it directly · 1 of its ownK202637 F3D Corpectomy SystemCorelink, LLC · 2020
- Descendant · cites it directly · 1 of its ownK200235 KONG-TL VBR System, KONG-C VBR SystemIcotec AG · 2020
- Descendant · cites it directly · 0 of its ownK252219 Cervical Interbody and VBR Fusion SystemSync Surgical · 2026
- Descendant · 2 generations on · 0 of its ownK232790 KONG®-TL VBR System and KONG® C VBR SystemIcotec AG · 2024
- Descendant · 2 generations on · 0 of its ownK230329 F3D Interbody SystemCorelink, LLC · 2023
Show all 14 generations
- Root · 14 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 13 generations backK012254 VBROsteotech, Inc. · 2001
- 12 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 11 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 10 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 9 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 8 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 7 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 6 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 5 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 4 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 3 generations backK151167 NuVasive PEEK Corpectomy SystemNu Vasive, Incorporated · 2015
- 2 generations backK170271 NuVasive (r) Monolith Corpectomy SystemNu Vasive, Incorporated · 2017
- 1 generation backK180550 NuVasive Monolith Cervical Corpectomy SystemNu Vasive, Incorporated · 2018
- This deviceK191778 Omnia Medical VBROmnia Medical, LLC · 2019
Most influential descendants
Showing 5 of 5 · See all- K202637F3D Corpectomy SystemCorelink, LLC · 2020 · cites it directly1descendant
- K200235KONG-TL VBR System, KONG-C VBR SystemIcotec AG · 2020 · cites it directly1descendant
- K252219Cervical Interbody and VBR Fusion SystemSync Surgical · 2026 · cites it directly0descendants
- K232790KONG®-TL VBR System and KONG® C VBR SystemIcotec AG · 2024 · 2 generations on0descendants
- K230329F3D Interbody SystemCorelink, LLC · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −13 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −12 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −11 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −10 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −9 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −8 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −7 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −6 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −5 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −4 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −3 | K151167 | NuVasive PEEK Corpectomy System | Nu Vasive, Incorporated | 2015 | — |
| −2 | K170271 | NuVasive (r) Monolith Corpectomy System | Nu Vasive, Incorporated | 2017 | — |
| −1 | K180550 | NuVasive Monolith Cervical Corpectomy System | Nu Vasive, Incorporated | 2018 | — |
| 0 (this device) | K191778 | Omnia Medical VBR | Omnia Medical, LLC | 2019 | — |
| +1 | K202637 | F3D Corpectomy System | Corelink, LLC | 2020 | — |
| +1 | K200235 | KONG-TL VBR System, KONG-C VBR System | Icotec AG | 2020 | — |
| +1 | K252219 | Cervical Interbody and VBR Fusion System | Sync Surgical | 2026 | — |
| +2 | K232790 | KONG®-TL VBR System and KONG® C VBR System | Icotec AG | 2024 | — |
| +2 | K230329 | F3D Interbody System | Corelink, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 6 | 0 |
| 2003 | 5 | 0 |
| 2004 | 5 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2015 | 3 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 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 PLR? 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 PLR device
- #1 K232481 RIGEL™ 3DR Anterior Cervical Corpectomy Systemscore 13.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K180550 | NuVasive Monolith Cervical Corpectomy SystemSummary page 4…Class II Reviewing Panel: Orthopedic Product Code: PLR, MQP Primary Predicate Device: NuVasive® Monolith™ Cervical Corpectomy System (K180550) The predicate device has never been subject to a recall. Additional Predicate Device: Omnia Medical… | 2018 |
| * | K172323 | Omnia Medical VBRSummary page 4…ervical Corpectomy System (K180550) The predicate device has never been subject to a recall. Additional Predicate Device: Omnia Medical VBR (K172323) The additional predicate device has never been subject to a recall. Device Description: The Omnia… | 2017 |
What descends from it? (5)
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 18 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 5 of the 44 ancestors have a recall of any class.
- Of its descendants, K202637 (Corelink, LLC, 2020) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K180550.
How does its category compare?
All PLR devicesPLR Spinal Vertebral Body Replacement Device - Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · PLR
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PLR
69in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PLR
No recall names PLR since 2007.
Adverse event reports per year · PLR
1in 2025
MAUDE reports naming product code PLR, 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 | 1 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 3 | 259 | 0 | 1 |
| 2019 | 5 | 69 | 0 | 1 |
| 2020 | 2 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 2 | — | 0 | 1 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Omnia Medical VBR is a vertebral body replacement system indicated for use in skeletally mature patients to replace a collapsed, damaged, diseased, or unstable vertebral body due to tumor or trauma (i.e. fracture) or for reconstruction following corpectomy performed to achieve decompression of the spinal cord and neural tissues. The device is intended for use in the cervical spine (from C3 to C7) and in the thoracolumbar spine (from T1-L5). The device is intended for use with supplemental fixation cleared by the FDA for use in the cervical, thoracic, or lumbar spine and is to be used with autogenous bone graft and/or allograft comprised of cancellous and/or corticocancellous bone graft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191778 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191778: Omnia Medical VBR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191778
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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