510(k) · Cleared
ClearedMosaic Devices
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 Oct 23, 2007 after a 112-day review. The FDA summary names no predicate by number. 1 of the 964 devices in its family, counting itself, has a Class I recall. 963 later devices descend from it.
- Decided
- Oct 23, 2007
- Review
- 112 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 0
963 later devices descend from it, 8 citing it directly. 1 of the 964 devices in this family, counting this one, has a Class I recall.
- This deviceK071833 Mosaic DevicesSpinal Elements, Inc. · 2007
- Descendant · cites it directly · 948 of its ownK072415 Stalif (TM) CSurgicraft, Ltd. · 2008
- Descendant · 2 generations on · 907 of its ownK073109 Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008
- Descendant · 3 generations on · 834 of its ownK083475 Lucent MagnumSpinal Elements, Inc. · 2009
- Descendant · 3 generations on · 753 of its ownK081849 Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 744 of its ownK100043 Coroent XLR Standalone SystemNuvasive, Inc. · 2010
Showing 5 of 963 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 963 · See all- K072415Stalif (TM) CSurgicraft, Ltd. · 2008 · cites it directly948descendants
- K073109Stalif TT Intervertebral Body Fusion SystemSurgicraft, Ltd. · 2008 · 2 generations on907descendants
- K083475Lucent MagnumSpinal Elements, Inc. · 2009 · 3 generations on834descendants
- K081849Blackstone Pillar SA Partial Vertebral Body Replacement DeviceBlackstone Medical, Inc. · 2008 · 3 generations on753descendants
- K100043Coroent XLR Standalone SystemNuvasive, Inc. · 2010 · 3 generations on744descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K071833 | Mosaic Devices | Spinal Elements, Inc. | 2007 | — |
| +1 | K072415 | Stalif (TM) C | Surgicraft, Ltd. | 2008 | — |
| +2 | K073109 | Stalif TT Intervertebral Body Fusion System | Surgicraft, Ltd. | 2008 | — |
| +3 | K083475 | Lucent Magnum | Spinal Elements, Inc. | 2009 | — |
| +3 | K081849 | Blackstone Pillar SA Partial Vertebral Body Replacement Device | Blackstone Medical, Inc. | 2008 | 1 |
| +3 | K100043 | Coroent XLR Standalone System | Nuvasive, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 5 | 0 |
| 2011 | 8 | 0 |
| 2012 | 7 | 0 |
| 2013 | 11 | 0 |
| 2014 | 21 | 0 |
| 2015 | 39 | 0 |
| 2016 | 56 | 0 |
| 2017 | 70 | 0 |
| 2018 | 73 | 0 |
| 2019 | 79 | 0 |
| 2020 | 94 | 0 |
| 2021 | 76 | 1 |
| 2022 | 78 | 0 |
| 2023 | 94 | 0 |
| 2024 | 94 | 0 |
| 2025 | 79 | 0 |
| 2026 | 73 | 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.
1 device in this family has a Class I recall. 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?
The FDA summary names no predicate by number.
What descends from it? (963)
See all 9638 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072415 | Stalif (TM) C | 2008 | 948 |
| K120819 | Stalif C | 2012 | 206 |
| K122771 | Spinal Elements Cervical Intervertebral Body Fusion System | 2013 | 147 |
| K133218 | Crystal ®; Mosaic ®; Vertu ® | 2014 | 130 |
| K181621 | Stable-C Interbody System | 2018 | 7 |
| K111272 | Rhausler Plage Anterior Cervical Fusion System | 2011 | 7 |
| K193153 | SPIRA-C Integrated Fixation System | 2020 | 2 |
| K192906 | Mecta-C Stand Alone | 2020 | 1 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K072415 (Surgicraft, Ltd., 2008) has gone furthest, with 948 descendants of its own.
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. 2007, 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?
When used as a vertebral body replacement, the Mosaic device is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture). This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e.…
Read the full statement (164 words)
When used as a vertebral body replacement, the Mosaic device is intended for use in the thoracic and/or thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body resected or excised (i.e., partial or total vertebrectomy procedures) due to tumor or trauma (i.e., fracture).
This device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the thoracic and/or lumbar spine (i.e., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). The interior of the spacer can be packed with allograft or autograft
When used as an intervertebral body fusion device, the Mosaic device is intended for spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as back 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.
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/K071833 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071833: Mosaic Devices.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071833
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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