De Novo · Granted
GrantedSpineology Interbody Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spineology, Inc. · OQB Intervertebral Body Graft Containment Device
Granted on Sep 18, 2020 as a new device type through De Novo after a 212-day review. 1 later device descends from it.
- Decided
- Sep 18, 2020
- Review
- 212 days
- Class
- Class II
- Product code
- OQB
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN200010 Spineology Interbody Fusion SystemSpineology, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK231781 OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc. · 2023
Most influential descendants
Showing 1 of 1 · See all- K231781OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc. · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN200010 | Spineology Interbody Fusion System | Spineology, Inc. | 2020 | — |
| +1 | K231781 | OptiMesh Multiplanar Expandable Interbody Fusion System | Spineology, Inc. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
Sources: FDA De Novo 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 OQB? 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 OQB device
- #1 K251302 OptiMesh Multiplanar Expandable Interbody…score 18.0 · 26 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231781 | OptiMesh Multiplanar Expandable Interbody Fusion System | 2023 | 0 |
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?
- Of its descendants, K231781 (Spineology, Inc., 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OQB devicesOQB Intervertebral Body Graft Containment Device: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · OQB
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OQB
Too few OQB 510(k)s in any year since 2007 to give a median.
Recalls per year · OQB
No recall names OQB since 2007.
Adverse event reports per year · OQB
10in 2025
MAUDE reports naming product code OQB, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 2 | — | 0 | 7 |
| 2024 | 0 | — | 0 | 6 |
| 2025 | 1 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Spineology Interbody Fusion System (SIFS) is indicated for use as an adjunct to fusion in an intervertebral body fusion at one level in the lumbar spine from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history, physical examination, and radiographic studies. Eligible patients shall have undergone six (6) months of conservative (non-operative) care. SIFS with compatible allograft and autograft is intended for use with supplemental posterior fixation systems intended for use in the lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN200010 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN200010: Spineology Interbody Fusion System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN200010
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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