510(k) · Cleared
ClearedOptiMesh Multiplanar Expandable 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
Cleared on Oct 18, 2023 as substantially equivalent to DEN200010 (Spineology, Inc., 2020) after a 124-day review. Its family tree reaches back 1 generation to 2020.
- Decided
- Oct 18, 2023
- Review
- 124 days
- Class
- Class II
- Product code
- OQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN200010 (2020). No later device cites it as a predicate yet.
- Root · 1 generation backDEN200010 Spineology Interbody Fusion SystemSpineology, Inc. · 2020
- This deviceK231781 OptiMesh Multiplanar Expandable Interbody Fusion SystemSpineology, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN200010 | Spineology Interbody Fusion System | Spineology, Inc. | 2020 | — |
| 0 (this device) | K231781 | OptiMesh Multiplanar Expandable Interbody Fusion System | Spineology, Inc. | 2023 | — |
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 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
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 |
|---|---|---|---|
| * | DEN200010 | Spineology Interbody Fusion SystemSummary page 4…OQB Regulatory Class: Class II Regulation Number: 21 CFR 888.3085 Panel: Orthopedic Predicate Device Primary: DEN200010 Spineology Interbody Fusion System Reference: K192047 Rampart™ One Lumbar Interbody Fusion Sy… | 2020 |
| † | K192047 | Rampart™ One Lumbar Interbody Fusion System | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- Its one ancestor has no recall.
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. 2023, 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 OptiMesh Multiplanar Expandable Interbody Fusion System 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 T 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.…
Read the full statement (108 words)
The OptiMesh Multiplanar Expandable Interbody Fusion System 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 T 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. The OptiMesh device with compatible allograft and autograft is intended for use with supplemental posterior fixation systems intended for use in the lumbar spine.
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/K231781 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231781: OptiMesh Multiplanar Expandable Interbody Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231781
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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