510(k) · Cleared
ClearedNuVasive (r) Monolith Corpectomy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nu Vasive, Incorporated · MQP Spinal Vertebral Body Replacement Device
Cleared on Mar 30, 2017 as substantially equivalent to K151167 (Nu Vasive, Incorporated, 2015) and 2 other predicates after a 62-day review. Its family tree reaches back 12 generations to 2001. 12 later devices descend from it.
- Decided
- Mar 30, 2017
- Review
- 62 days
- Class
- Class II
- Product code
- MQP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K003155 (2001). 29 ancestors in all, the oldest K841189 (1984). 12 later devices descend from it, 1 citing it directly.
- Root · 12 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 8 generations between
- 3 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 2 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 1 generation backK151167 NuVasive PEEK Corpectomy SystemNu Vasive, Incorporated · 2015
- This deviceK170271 NuVasive (r) Monolith Corpectomy SystemNu Vasive, Incorporated · 2017
- Descendant · cites it directly · 11 of its ownK180550 NuVasive Monolith Cervical Corpectomy SystemNu Vasive, Incorporated · 2018
- Descendant · 2 generations on · 5 of its ownK191778 Omnia Medical VBROmnia Medical, LLC · 2019
- Descendant · 2 generations on · 3 of its ownK190426 ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC · 2019
- Descendant · 3 generations on · 2 of its ownK233359 DOMINION Expandable Corpectomy SystemAstura Medical · 2024
- Descendant · 4 generations on · 1 of its ownK241468 Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc. · 2024
Show all 12 generations
- Root · 12 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 11 generations backK012254 VBROsteotech, Inc. · 2001
- 10 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 9 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 8 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 7 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 6 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 5 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 4 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 3 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 2 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 1 generation backK151167 NuVasive PEEK Corpectomy SystemNu Vasive, Incorporated · 2015
- This deviceK170271 NuVasive (r) Monolith Corpectomy SystemNu Vasive, Incorporated · 2017
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K180550NuVasive Monolith Cervical Corpectomy SystemNu Vasive, Incorporated · 2018 · cites it directly11descendants
- K191778Omnia Medical VBROmnia Medical, LLC · 2019 · 2 generations on5descendants
- K190426ALTA Anterior Cervical Corpectomy SystemAstura Medical, LLC · 2019 · 2 generations on3descendants
- K233359DOMINION Expandable Corpectomy SystemAstura Medical · 2024 · 3 generations on2descendants
- K241468Vertiwedge® Intraosseous SystemFoundation Surgical Group, Inc. · 2024 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −11 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −10 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −9 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −8 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −7 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −6 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −5 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −4 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −3 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −2 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −1 | K151167 | NuVasive PEEK Corpectomy System | Nu Vasive, Incorporated | 2015 | — |
| 0 (this device) | K170271 | NuVasive (r) Monolith Corpectomy System | Nu Vasive, Incorporated | 2017 | — |
| +1 | K180550 | NuVasive Monolith Cervical Corpectomy System | Nu Vasive, Incorporated | 2018 | — |
| +2 | K191778 | Omnia Medical VBR | Omnia Medical, LLC | 2019 | — |
| +2 | K190426 | ALTA Anterior Cervical Corpectomy System | Astura Medical, LLC | 2019 | — |
| +3 | K233359 | DOMINION Expandable Corpectomy System | Astura Medical | 2024 | — |
| +4 | K241468 | Vertiwedge® Intraosseous System | Foundation Surgical Group, Inc. | 2024 | — |
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 |
| 2009 | 1 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 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 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? (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 |
|---|---|---|---|
| * | K151167 | NuVasive PEEK Corpectomy SystemSummary page 4…Product Code: MQP C. Predicate Devices The subject Monolith Corpectomy System is substantially equivalent to primary predicate device, NuVasive PEEK Corpectomy System (K151167), and additional predicate devices: NuVasive PEEK Corpectomy Railed System (K151538), NuVasive X-CORE Expandable VBR System (K142… | 2015 |
| * | K151538 | NuVasive PEEK Corpectomy Railed SystemSummary page 4…ubstantially equivalent to primary predicate device, NuVasive PEEK Corpectomy System (K151167), and additional predicate devices: NuVasive PEEK Corpectomy Railed System (K151538), NuVasive X-CORE Expandable VBR System (K142205), and reference device NuVasive Lumbar Interbody Implants (K161230). D. Device… | 2015 |
| * | K142205 | NuVasive X-CORE (R) Expandable VBR SystemSummary page 4…ce, NuVasive PEEK Corpectomy System (K151167), and additional predicate devices: NuVasive PEEK Corpectomy Railed System (K151538), NuVasive X-CORE Expandable VBR System (K142205), and reference device NuVasive Lumbar Interbody Implants (K161230). D. Device Description The Monolith Corpectomy System is a v… | 2015 |
| † | K161230 | NuVasive Lumbar Interbody Implants | 2016 |
What descends from it? (12)
See all 121 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180550 | NuVasive Monolith Cervical Corpectomy System | 2018 | 11 |
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 16 years and passes through 5 companies; a new generation was cleared every 9 months on median.
- 3 of the 29 ancestors have a recall of any class.
- Of its descendants, K180550 (Nu Vasive, Incorporated, 2018) has gone furthest, with 11 descendants 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. 2017, 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 NuVasive® Monolith Corpectomy System is a partial or total vertebral body replacement device indicated for use in the thoracolumbar spine (T1 to L5) to replace a diseased or damaged vertebral body caused by tumor or fracture, to restore height of a collapsed vertebral body, and to achieve decompression of the spinal cord and neural tissues. The Monolith Corpectomy System is intended to be used with supplemental internal spinal fixation systems that are cleared by the FDA for use in the thoracic and lumbar spine. Allograft or autograft material may be 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/K170271 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170271: NuVasive (r) Monolith 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/K170271
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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