510(k) · Cleared
ClearedADI Cervical Interbody Fusion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Additive Device, Inc. (Adi) D/B/A Restor3D · ODP Intervertebral Fusion Device With Bone Graft, Cervical
Cleared on Oct 24, 2019 as substantially equivalent to K073351 (Spinal Elements, Inc., 2008) after a 111-day review. Its family tree reaches back 1 generation to 2008. 2 later devices descend from it.
- Decided
- Oct 24, 2019
- Review
- 111 days
- Class
- Class II
- Product code
- ODP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K073351 (2008). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK073351 CrystalSpinal Elements, Inc. · 2008
- This deviceK191812 ADI Cervical Interbody Fusion DeviceAdditive Device, Inc. (Adi) D/B/A Restor3D · 2019
- Descendant · cites it directly · 0 of its ownK253894 BMD Titanium Spinal Fusion SystemGlobal Biomedica s.r.o. · 2026
- Descendant · cites it directly · 0 of its ownK252432 Flex-Z™ Cervical CageSpinepoint, LLC · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K073351 | Crystal | Spinal Elements, Inc. | 2008 | — |
| 0 (this device) | K191812 | ADI Cervical Interbody Fusion Device | Additive Device, Inc. (Adi) D/B/A Restor3D | 2019 | — |
| +1 | K253894 | BMD Titanium Spinal Fusion System | Global Biomedica s.r.o. | 2026 | — |
| +1 | K252432 | Flex-Z™ Cervical Cage | Spinepoint, LLC | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 2 | 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 ODP? 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 ODP device
- #1 K222276 CONDUIT Cages; FIBERGRAFT BG Puttyscore 53.4 · 25 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 |
|---|---|---|---|
| * | K073351 | CrystalSummary page 4…n: Intervertebral Body Fusion Device (Class II) 21 CFR 888.3080 E. Predicate Device(s): Spinal Elements Crystal®, K073351 F. Physical Description: The proposed ADI Cervical Interbody Fusion Device is a sterile, single use i… | 2008 |
What descends from it? (2)
2 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?
How does its category compare?
All ODP devicesODP Intervertebral Fusion Device With Bone Graft, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · ODP
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ODP
87in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ODP
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ODP
57in 2025
MAUDE reports naming product code ODP, 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 | 8 | 89 | 0 | 2 |
| 2009 | 12 | 127 | 1 | 21 |
| 2010 | 9 | 151 | 0 | 54 |
| 2011 | 25 | 113 | 1 | 38 |
| 2012 | 17 | 93 | 0 | 92 |
| 2013 | 18 | 187 | 1 | 78 |
| 2014 | 26 | 118 | 0 | 43 |
| 2015 | 24 | 180 | 0 | 51 |
| 2016 | 17 | 112 | 0 | 37 |
| 2017 | 33 | 104 | 0 | 39 |
| 2018 | 25 | 133 | 0 | 51 |
| 2019 | 22 | 92 | 0 | 141 |
| 2020 | 14 | 89 | 1 | 86 |
| 2021 | 18 | 121 | 0 | 161 |
| 2022 | 12 | 92 | 0 | 50 |
| 2023 | 34 | 165 | 0 | 36 |
| 2024 | 10 | 76 | 0 | 55 |
| 2025 | 11 | 87 | 2 | 57 |
| 2026 | 19 | 117 | 0 | — |
What is it indicated for?
The restor3d Cervical Interbody Fusion Device is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Implants are used to facilitate fusion in the cervical spine (C3-C7) and are placed via an anterior approach using autogenous bone as graft material for the interior graft window. The device is intended to be used with supplemental fixation systems that have been cleared for use in the cervical spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K191812 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191812: ADI Cervical Interbody Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191812
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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