510(k) · Cleared
ClearedCrystal ®; Mosaic ®; Vertu ®
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 Dec 10, 2014 as substantially equivalent to K112036 (X-Spine Systems, Inc., 2011) and 3 other predicates after a 418-day review. Its family tree reaches back 3 generations to 2008. 130 later devices descend from it.
- Decided
- Dec 10, 2014
- Review
- 418 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K072991 (2008). 8 ancestors in all, the oldest P980048 (2001). 130 later devices descend from it, 6 citing it directly.
- Root · 3 generations backK072991 Patriot Spacers: Colonial AcdfGlobus Medical, Inc. · 2008
- 2 generations backK083389 Coalition SpacerGlobus Medical, Inc. · 2009
- 1 generation backK122771 Spinal Elements Cervical Intervertebral Body Fusion SystemSpinal Elements, Inc. · 2013
- This deviceK133218 Crystal ®; Mosaic ®; Vertu ®Spinal Elements, Inc. · 2014
- Descendant · cites it directly · 98 of its ownK181837 Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc. · 2018
- Descendant · 2 generations on · 93 of its ownK190546 NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019
- Descendant · 3 generations on · 72 of its ownK200543 NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC · 2020
- Descendant · 4 generations on · 67 of its ownK202812 IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. · 2020
- Descendant · 5 generations on · 59 of its ownK203742 IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021
Showing 5 of 130 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 130 · See all- K181837Spinal Elements Ti-Bond coated devicesSpinal Elements, Inc. · 2018 · cites it directly98descendants
- K190546NEXXT MATRIXX Stand Alone Cervical SystemNexxt Spine, LLC · 2019 · 2 generations on93descendants
- K200543NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) SystemNexxt Spine, LLC · 2020 · 3 generations on72descendants
- K202812IdentiTi Cervical Standalone Interbody SystemAlphatec Spine, Inc. · 2020 · 4 generations on67descendants
- K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021 · 5 generations on59descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K072991 | Patriot Spacers: Colonial Acdf | Globus Medical, Inc. | 2008 | — |
| −2 | K083389 | Coalition Spacer | Globus Medical, Inc. | 2009 | — |
| −1 | K122771 | Spinal Elements Cervical Intervertebral Body Fusion System | Spinal Elements, Inc. | 2013 | — |
| 0 (this device) | K133218 | Crystal ®; Mosaic ®; Vertu ® | Spinal Elements, Inc. | 2014 | — |
| +1 | K181837 | Spinal Elements Ti-Bond coated devices | Spinal Elements, Inc. | 2018 | — |
| +2 | K190546 | NEXXT MATRIXX Stand Alone Cervical System | Nexxt Spine, LLC | 2019 | — |
| +3 | K200543 | NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System | Nexxt Spine, LLC | 2020 | — |
| +4 | K202812 | IdentiTi Cervical Standalone Interbody System | Alphatec Spine, Inc. | 2020 | — |
| +5 | K203742 | IdentiTi ALIF Standalone Interbody System | Alphatec Spine, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 7 | 0 |
| 2021 | 3 | 0 |
| 2022 | 15 | 0 |
| 2023 | 23 | 0 |
| 2024 | 23 | 0 |
| 2025 | 27 | 0 |
| 2026 | 25 | 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? (4)
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 |
|---|---|---|---|
| * | K112036 | Calix PC Spinal Implant SystemSummary page 5…d Vertu III. PREDICATE DEVICE Primary Predicate Name Calix PC Regulatory Class Class II Submission No K112036 Device Code ODP Predicate Name Crystal®; Mosaic®; Vertu® Systems Regulatory… | 2011 |
| * | K073351 | CrystalSummary page 5…ODP Predicate Name Crystal®; Mosaic®; Vertu® Systems Regulatory Class Class II Submission No K073351 – K071833 – K122771 Device Code ODP – Crystal OVE – Mosaic an… | 2008 |
| * | K071833 | Mosaic DevicesSummary page 5…dicate Name Crystal®; Mosaic®; Vertu® Systems Regulatory Class Class II Submission No K073351 – K071833 – K122771 Device Code ODP – Crystal OVE – Mosaic and Vertu… | 2007 |
| * | K122771 | Spinal Elements Cervical Intervertebral Body Fusion SystemSummary page 5…e Crystal®; Mosaic®; Vertu® Systems Regulatory Class Class II Submission No K073351 – K071833 – K122771 Device Code ODP – Crystal OVE – Mosaic and Vertu… | 2013 |
What descends from it? (130)
See all 1306 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 6 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K181837 (Spinal Elements, Inc., 2018) has gone furthest, with 98 descendants of its own.
- 11 other devices also cite its predicate K112036.
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. 2014, 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?
Crystal®: The Crystal® device is intended for spinal fusion procedures at one level (C3-C7) 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 autogenous bone. The Crystal® device is intended to be used with supplemental spinal…
Read the full statement (322 words)
Crystal®:
The Crystal® device is intended for spinal fusion procedures at one level (C3-C7) 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 autogenous bone.
The Crystal® device is intended to be used with supplemental spinal 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.
Mosaic®:
The Mosaic® device is an interbody fusion device intended for spinal fusion procedures at one level (C3-C7) 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 autogenous bone.
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, three, or four screws. The maximum number of screws should be used to ensure adequate fixation of the implant.
Vertu®:
The Vertu® device is a stand-alone interbody fusion device intended for spinal fusion procedures at one level (C3-C7) 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 autogenous bone.
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133218 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133218: Crystal ®; Mosaic ®; Vertu ®.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133218
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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