510(k) · Cleared
ClearedCavetto-SA Cervical Cage System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neurostructures, Inc. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Sep 24, 2020 as substantially equivalent to K173077 (Neurostructures, Inc., 2018) after a 247-day review. Its family tree reaches back 16 generations to 2001. 19 later devices descend from it.
- Decided
- Sep 24, 2020
- Review
- 247 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K003155 (2001). 144 ancestors in all, the oldest K792352 (1979). 19 later devices descend from it, 1 citing it directly.
- Root · 16 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 12 generations between
- 3 generations backK112388 Lanx Cervical SALanx, Inc. · 2011
- 2 generations backK132894 Optio-C Anterior Cervical SystemZimmer Spine, Inc. · 2014
- 1 generation backK173077 Cavetto-SA Cervical Cage SystemNeurostructures, Inc. · 2018
- This deviceK200115 Cavetto-SA Cervical Cage SystemNeurostructures, Inc. · 2020
- Descendant · cites it directly · 18 of its ownK212853 Cervical Stand-Alone SystemEminent Spine, LLC · 2021
- Descendant · 2 generations on · 5 of its ownK223105 Tesera-K SC SystemKyocera Medical Technologies, Inc. · 2022
- Descendant · 2 generations on · 5 of its ownK223190 Hive™ Standalone Cervical SystemNanoHive Medical, LLC · 2022
- Descendant · 2 generations on · 4 of its ownK240838 Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc. · 2024
- Descendant · 3 generations on · 3 of its ownK242260 aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical…Carlsmed, Inc. · 2024
Show all 16 generations
- Root · 16 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
- 15 generations backK012254 VBROsteotech, Inc. · 2001
- 14 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 13 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
- 12 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
- 11 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 10 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 9 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
- 8 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
- 7 generations backK062133 Modification to Verte-Stack Spinal SystemMedtronic Spinal and Biologics Div · 2006
- 6 generations backK070173 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2007
- 5 generations backK073285 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek USA, Inc. · 2008
- 4 generations backK094042 Peek Prevail Cervical Interbody DeviceMedtronic Sofamor Danek · 2010
- 3 generations backK112388 Lanx Cervical SALanx, Inc. · 2011
- 2 generations backK132894 Optio-C Anterior Cervical SystemZimmer Spine, Inc. · 2014
- 1 generation backK173077 Cavetto-SA Cervical Cage SystemNeurostructures, Inc. · 2018
- This deviceK200115 Cavetto-SA Cervical Cage SystemNeurostructures, Inc. · 2020
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K212853Cervical Stand-Alone SystemEminent Spine, LLC · 2021 · cites it directly18descendants
- K223105Tesera-K SC SystemKyocera Medical Technologies, Inc. · 2022 · 2 generations on5descendants
- K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC · 2022 · 2 generations on5descendants
- K240838Spectrum Spine Cervical Cage SystemSpectrum Spine, Inc. · 2024 · 2 generations on4descendants
- K242260aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAMCarlsmed, Inc. · 2024 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K003155 | Vertebral Body Replacement | Osteotech, Inc. | 2001 | — |
| −15 | K012254 | VBR | Osteotech, Inc. | 2001 | — |
| −14 | K021791 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −13 | K023570 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2002 | — |
| −12 | K030601 | Verte-Stack Spinal System | Medtronic Sofamor Danek | 2003 | — |
| −11 | K040536 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −10 | K041556 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −9 | K043561 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −8 | K060719 | Modification to Verte-Stack Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −7 | K062133 | Modification to Verte-Stack Spinal System | Medtronic Spinal and Biologics Div | 2006 | — |
| −6 | K070173 | Verte-Stack Spinal System | Medtronic Sofamor Danek, Inc. | 2007 | — |
| −5 | K073285 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek USA, Inc. | 2008 | — |
| −4 | K094042 | Peek Prevail Cervical Interbody Device | Medtronic Sofamor Danek | 2010 | — |
| −3 | K112388 | Lanx Cervical SA | Lanx, Inc. | 2011 | — |
| −2 | K132894 | Optio-C Anterior Cervical System | Zimmer Spine, Inc. | 2014 | — |
| −1 | K173077 | Cavetto-SA Cervical Cage System | Neurostructures, Inc. | 2018 | — |
| 0 (this device) | K200115 | Cavetto-SA Cervical Cage System | Neurostructures, Inc. | 2020 | — |
| +1 | K212853 | Cervical Stand-Alone System | Eminent Spine, LLC | 2021 | — |
| +2 | K223105 | Tesera-K SC System | Kyocera Medical Technologies, Inc. | 2022 | — |
| +2 | K223190 | Hive™ Standalone Cervical System | NanoHive Medical, LLC | 2022 | — |
| +2 | K240838 | Spectrum Spine Cervical Cage System | Spectrum Spine, Inc. | 2024 | — |
| +3 | K242260 | aprevo® Cervical ACDF; aprevo® Cervical ACDF-X; aprevo® Cervical ACDF-X NO CAM | Carlsmed, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1984 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 9 | 0 |
| 2002 | 6 | 0 |
| 2003 | 12 | 0 |
| 2004 | 20 | 0 |
| 2005 | 10 | 0 |
| 2006 | 6 | 0 |
| 2007 | 9 | 0 |
| 2008 | 19 | 0 |
| 2009 | 11 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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 OVE? 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 OVE device
- #1 K241846 E3D™-C Interbody Systemscore 32.1 · 32 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 |
|---|---|---|---|
| * | K173077 | Cavetto-SA Cervical Cage SystemSummary page 5…de or Proprietary Predicate Manufacturer Number or Model Name Type K173077 Cavetto-SA Cervical Primary NeuroStructures… | 2018 |
| † | K172064 | Ti-Diagon Oblique TLIF | 2017 |
| † | K172320 | Neurostructures Cavetto® Cervical Cage System | 2018 |
| † | K142041 | Porosteon Phusion Metal Cervical Cage | 2014 |
| † | K153097 | Belvedere™ Lateral Plating System | 2016 |
What descends from it? (19)
See all 191 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212853 | Cervical Stand-Alone System | 2021 | 18 |
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 19 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
- 15 of the 144 ancestors have a recall of any class.
- Of its descendants, K212853 (Eminent Spine, LLC, 2021) has gone furthest, with 18 descendants of its own.
- 3 other devices also cite its predicate K173077.
How does its category compare?
All OVE devicesOVE Intervertebral Fusion Device With Integrated Fixation, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · OVE
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVE
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVE
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVE
132in 2025
MAUDE reports naming product code OVE, 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 | 1 | — | 0 | 0 |
| 2008 | 4 | 131 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 210 | 0 | 2 |
| 2011 | 8 | 139 | 0 | 19 |
| 2012 | 7 | 125 | 0 | 59 |
| 2013 | 5 | 71 | 1 | 250 |
| 2014 | 11 | 168 | 1 | 150 |
| 2015 | 12 | 113 | 1 | 173 |
| 2016 | 15 | 149 | 1 | 145 |
| 2017 | 9 | 100 | 1 | 134 |
| 2018 | 7 | 105 | 0 | 210 |
| 2019 | 7 | 87 | 0 | 169 |
| 2020 | 13 | 149 | 0 | 162 |
| 2021 | 10 | 93 | 2 | 186 |
| 2022 | 10 | 144 | 0 | 200 |
| 2023 | 16 | 97 | 0 | 148 |
| 2024 | 6 | 56 | 0 | 142 |
| 2025 | 10 | 105 | 0 | 132 |
| 2026 | 13 | 66 | 0 | — |
What is it indicated for?
The Cavetto®-SA Cervical Cage System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be implanted via an open, anterior approach and packed with autograft bone and/or allogenic bone graft composed of cancellous and/or…
Read the full statement (110 words)
The Cavetto®-SA Cervical Cage System is intended for spinal fusion procedures at one level (C2 to T1) in skeletally mature patients with degenerative disc disease (defined as pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are intended to be implanted via an open, anterior approach and packed with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone graft. This cervical device is to be used in patients who have had six weeks of non-operative treatment. The Cavetto®-SA Cervical Cage System should be used with the provided bone screws and requires no additional supplementary fixation systems.
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/K200115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200115: Cavetto-SA Cervical Cage System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200115
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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