510(k) · Cleared
ClearedNuVasive Monolith Cervical Corpectomy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nu Vasive, Incorporated · PLR Spinal Vertebral Body Replacement Device - Cervical
Cleared on Nov 20, 2018 as substantially equivalent to K151651 (Nu Vasive, Incorporated, 2015) and 2 other predicates after a 264-day review. Its family tree reaches back 13 generations to 2001. 11 later devices descend from it.
- Decided
- Nov 20, 2018
- Review
- 264 days
- Class
- Class II
- Product code
- PLR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K003155 (2001). 32 ancestors in all, the oldest K841189 (1984). 11 later devices descend from it, 4 citing it directly.
- Root · 13 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 9 generations between
- 3 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 2 generations backK151167 NuVasive PEEK Corpectomy SystemNu Vasive, Incorporated · 2015
- 1 generation backK170271 NuVasive (r) Monolith Corpectomy SystemNu Vasive, Incorporated · 2017
- This deviceK180550 NuVasive Monolith Cervical Corpectomy SystemNu Vasive, Incorporated · 2018
- Descendant · cites it directly · 5 of its ownK191778 Omnia Medical VBROmnia Medical, LLC · 2019
- Descendant · cites it directly · 3 of its ownK190426 ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC · 2019
- Descendant · 2 generations on · 2 of its ownK233359 DOMINION Expandable Corpectomy SystemAstura Medical · 2024
- Descendant · 3 generations on · 1 of its ownK241468 Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc. · 2024
- Descendant · 2 generations on · 1 of its ownK202637 F3D Corpectomy SystemCorelink, LLC · 2020
Show all 13 generations
- Root · 13 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 12 generations backK012254 VBROsteotech, Inc. · 2001
- 11 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 10 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 9 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 8 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 7 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 6 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 5 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 4 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 3 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 2 generations backK151167 NuVasive PEEK Corpectomy SystemNu Vasive, Incorporated · 2015
- 1 generation backK170271 NuVasive (r) Monolith Corpectomy SystemNu Vasive, Incorporated · 2017
- This deviceK180550 NuVasive Monolith Cervical Corpectomy SystemNu Vasive, Incorporated · 2018
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K191778Omnia Medical VBROmnia Medical, LLC · 2019 · cites it directly5descendants
- K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC · 2019 · cites it directly3descendants
- K233359DOMINION Expandable Corpectomy SystemAstura Medical · 2024 · 2 generations on2descendants
- K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc. · 2024 · 3 generations on1descendant
- K202637F3D Corpectomy SystemCorelink, LLC · 2020 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −12 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −11 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −10 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −9 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −8 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −7 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −6 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −5 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −4 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −3 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −2 | K151167 | NuVasive PEEK Corpectomy System | Nu Vasive, Incorporated | 2015 | — |
| −1 | K170271 | NuVasive (r) Monolith Corpectomy System | Nu Vasive, Incorporated | 2017 | — |
| 0 (this device) | K180550 | NuVasive Monolith Cervical Corpectomy System | Nu Vasive, Incorporated | 2018 | — |
| +1 | K191778 | Omnia Medical VBR | Omnia Medical, LLC | 2019 | — |
| +1 | K190426 | ALTA Anterior Cervical Corpectomy System | Astura Medical, LLC | 2019 | — |
| +2 | K233359 | DOMINION Expandable Corpectomy System | Astura Medical | 2024 | — |
| +3 | K241468 | Vertiwedge® Intraosseous System | Foundation Surgical Group, Inc. | 2024 | — |
| +2 | K202637 | F3D Corpectomy System | Corelink, LLC | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2015 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2026 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K151651 | NuVasive X-CORE Mini Cervical Expandable VBR SystemSummary page 4…The subject Monolith Cervical Corpectomy System is substantially equivalent to a primary predicate device, NuVasive X-Core® Mini Cervical Expandable VBR System (K151651), and additional predicate devices, Monolith Corpectomy System (K170271) and NuVasive CoRoent System (K081611). D. D… | 2015 |
| * | K170271 | NuVasive (r) Monolith Corpectomy SystemSummary page 4…nt to a primary predicate device, NuVasive X-Core® Mini Cervical Expandable VBR System (K151651), and additional predicate devices, Monolith Corpectomy System (K170271) and NuVasive CoRoent System (K081611). D. Device Description The NuVasive Monolith Cervical Corpectomy System is a… | 2017 |
| * | K081611 | Nuvasive Coroent SystemSummary page 4…sive X-Core® Mini Cervical Expandable VBR System (K151651), and additional predicate devices, Monolith Corpectomy System (K170271) and NuVasive CoRoent System (K081611). D. Device Description The NuVasive Monolith Cervical Corpectomy System is a vertebral body replacement system manu… | 2008 |
What descends from it? (11)
See all 114 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 17 years and passes through 5 companies; a new generation was cleared every 9 months on median.
- 3 of the 32 ancestors have a recall of any class.
- Of its descendants, K191778 (Omnia Medical, LLC, 2019) has gone furthest, with 5 descendants of its own.
- 8 other devices also cite its predicate K151651.
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. 2018, 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 NuVasive Monolith Cervical Corpectomy System is a vertebral body replacement device indicated for use in the cervical spine (C3-C7 vertebral bodies) 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 cervical degenerative disorders. The NuVasive® Monolith…
Read the full statement (167 words)
The NuVasive Monolith Cervical Corpectomy System is a vertebral body replacement device indicated for use in the cervical spine (C3-C7 vertebral bodies) 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 cervical degenerative disorders. The NuVasive® Monolith Cervical Corpectomy System is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine.
These implants are intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. The NuVasive® Monolith Cervical Corpectomy 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, with bone graft used at the surgeon’s discretion.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K180550 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180550: NuVasive Monolith Cervical Corpectomy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180550
Report an extraction error
Are you the manufacturer?
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