510(k) · Cleared
ClearedVertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal Elements, Inc. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Aug 1, 2016 as substantially equivalent to K150053 (Centinel Spine, Inc., 2015) after a 255-day review. Its family tree reaches back 3 generations to 2013. 46 later devices descend from it.
- Decided
- Aug 1, 2016
- Review
- 255 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K130177 (2013). 46 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK130177 Anatomic Peek Cervical Fusion SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 2 generations backK142079 Stalif Cti, Stalif CCentinel Spine, Inc. · 2014
- 1 generation backK150053 STALIF C; STALIF C-TiCentinel Spine, Inc. · 2015
- This deviceK153352 Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical…Spinal Elements, Inc. · 2016
- Descendant · cites it directly · 37 of its ownK180909 REVEL SpacersGlobus Medical, Inc. · 2018
- Descendant · 2 generations on · 36 of its ownK191243 HEDRON Cervical SpacersGlobus Medical, Inc. · 2019
- Descendant · 3 generations on · 23 of its ownK222270 HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable…Globus Medical, Inc. · 2022
- Descendant · 4 generations on · 6 of its ownK241846 E3D™-C Interbody SystemEvolution Spine · 2024
- Descendant · 4 generations on · 5 of its ownK243635 aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc. · 2024
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K180909REVEL SpacersGlobus Medical, Inc. · 2018 · cites it directly37descendants
- K191243HEDRON Cervical SpacersGlobus Medical, Inc. · 2019 · 2 generations on36descendants
- K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc. · 2022 · 3 generations on23descendants
- K241846E3D™-C Interbody SystemEvolution Spine · 2024 · 4 generations on6descendants
- K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc. · 2024 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K130177 | Anatomic Peek Cervical Fusion System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −2 | K142079 | Stalif Cti, Stalif C | Centinel Spine, Inc. | 2014 | — |
| −1 | K150053 | STALIF C; STALIF C-Ti | Centinel Spine, Inc. | 2015 | — |
| 0 (this device) | K153352 | Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody… | Spinal Elements, Inc. | 2016 | — |
| +1 | K180909 | REVEL Spacers | Globus Medical, Inc. | 2018 | — |
| +2 | K191243 | HEDRON Cervical Spacers | Globus Medical, Inc. | 2019 | — |
| +3 | K222270 | HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer… | Globus Medical, Inc. | 2022 | — |
| +4 | K241846 | E3D™-C Interbody System | Evolution Spine | 2024 | — |
| +4 | K243635 | aprevo® anterior lumbar interbody fusion device with interfixation | Carlsmed, Inc. | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 6 | 0 |
| 2024 | 9 | 0 |
| 2025 | 12 | 0 |
| 2026 | 13 | 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 |
|---|---|---|---|
| * | K150053 | STALIF C; STALIF C-TiSummary page 7…ons for use, surgical technique, design features and instrumentation to the following predicate devices: Primary Predicate e Centinel Spine’s STALIF C® and STALIF C-Ti™ (K150053) Reference Devices e Spinal Elements’ Vertu® and Vertu® Ti-Bond Cervical Interbody System (K122771, K133218). e Spinal Elements’… | 2015 |
| † | K122771 | Spinal Elements Cervical Intervertebral Body Fusion System | 2013 |
| † | K133218 | Crystal ®; Mosaic ®; Vertu ® | 2014 |
| † | K073351 | Crystal | 2008 |
| † | K142264 | Valeo C Spacer System, Valeo II C IBF Device | 2014 |
| † | K133653 | Anatomic Peek PTC Cervical Fusion System | 2014 |
What descends from it? (46)
See all 464 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 3 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K180909 (Globus Medical, Inc., 2018) has gone furthest, with 37 descendants of its own.
- 8 other devices also cite its predicate K150053.
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. 2016, 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?
Vertu® & Vertu® Ti-Bond devices are stand-alone interbody fusion devices intended for spinal fusion procedures at one level from the C2/C3 disc space to the C7/T1 disc space in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with…
Read the full statement (251 words)
Vertu® & Vertu® Ti-Bond devices are stand-alone interbody fusion devices intended for spinal fusion procedures at one level from the C2/C3 disc space to the C7/T1 disc space in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices.
The implant is designed to accommodate two screws. Two screws should be used to ensure adequate fixation of the implant.
Crystal® & Crystal® Ti-Bond devices are intended for spinal fusion at one or two contiguous levels in skeletally mature patients with degenerative disc disease (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Implants are to be implanted via an open, anterior approach from the C2-C3 disc space to the C7-T1 disc space and packed with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft.
The device is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine (i.e., anterior plate systems).
Patients must have undergone a regimen of at least six (6) weeks non-operative treatment prior to being treated with these devices.
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/K153352 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153352: Vertu® & Vertu® Ti-Bond and Crystal® & Crystal® Ti-Bond Cervical Interbody System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153352
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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