510(k) · Cleared
ClearedSpinal Usa Interbody Fusion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinal USA · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on May 13, 2008 after a 97-day review. The FDA summary names no predicate by number. 40 later devices descend from it.
- Decided
- May 13, 2008
- Review
- 97 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 0
40 later devices descend from it, 3 citing it directly.
- This deviceK080314 Spinal Usa Interbody Fusion DeviceSpinal USA · 2008
- Descendant · cites it directly · 26 of its ownK133827 A-Link ZOsteo Vasive, LLC · 2014 · Recalled
- Descendant · 2 generations on · 25 of its ownK201671 A-Link ZAcuity Surgical Devices, LLC · 2021
- Descendant · 3 generations on · 14 of its ownK222561 AlignAcuity Surgical Devices, LLC · 2022
- Descendant · cites it directly · 10 of its ownK110442 Nanovis Intervertebral Body Fusion SystemNanovis, LLC · 2011
- Descendant · 2 generations on · 9 of its ownK140280 ForticoreNanovis, LLC · 2014
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K133827A-Link ZOsteo Vasive, LLC · 2014 · cites it directly26descendants
- K201671A-Link ZAcuity Surgical Devices, LLC · 2021 · 2 generations on25descendants
- K222561AlignAcuity Surgical Devices, LLC · 2022 · 3 generations on14descendants
- K110442Nanovis Intervertebral Body Fusion SystemNanovis, LLC · 2011 · cites it directly10descendants
- K140280ForticoreNanovis, LLC · 2014 · 2 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K080314 | Spinal Usa Interbody Fusion Device | Spinal USA | 2008 | — |
| +1 | K133827 | A-Link Z | Osteo Vasive, LLC | 2014 | 2 |
| +2 | K201671 | A-Link Z | Acuity Surgical Devices, LLC | 2021 | — |
| +3 | K222561 | Align | Acuity Surgical Devices, LLC | 2022 | — |
| +1 | K110442 | Nanovis Intervertebral Body Fusion System | Nanovis, LLC | 2011 | — |
| +2 | K140280 | Forticore | Nanovis, LLC | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 1 | 0 |
| 2024 | 10 | 0 |
| 2025 | 5 | 0 |
| 2026 | 8 | 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 MAX? 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 MAX device
- #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 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? (40)
See all 403 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?
- Of its descendants, K133827 (Osteo Vasive, LLC, 2014) has gone furthest, with 26 descendants of its own.
How does its category compare?
All MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MAX
29in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MAX
85in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MAX
5in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · MAX
811in 2025
MAUDE reports naming product code MAX, 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 | 7 | 86 | 0 | 12 |
| 2008 | 35 | 88 | 2 | 19 |
| 2009 | 31 | 102 | 9 | 90 |
| 2010 | 29 | 137 | 0 | 154 |
| 2011 | 49 | 98 | 3 | 201 |
| 2012 | 48 | 69 | 11 (1) | 327 |
| 2013 | 58 | 102 | 0 | 380 |
| 2014 | 58 | 115 | 3 | 366 |
| 2015 | 53 | 113 | 1 | 524 |
| 2016 | 64 | 124 | 6 | 647 |
| 2017 | 76 | 116 | 1 | 596 |
| 2018 | 64 | 114 | 4 | 616 |
| 2019 | 60 | 131 | 1 | 699 |
| 2020 | 56 | 106 | 0 | 640 |
| 2021 | 53 | 109 | 0 | 622 |
| 2022 | 41 | 95 | 1 | 618 |
| 2023 | 30 | 87 | 0 | 576 |
| 2024 | 38 | 91 | 1 | 729 |
| 2025 | 29 | 85 | 5 | 811 |
| 2026 | 18 | 95 | 0 | — |
What is it indicated for?
The Spinal USA Interbody Fusion Device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space. The Spinal USA Interbody Fusion Device ACIF System is intended for use in the cervical spine, from C3 to T1, for the treatment of cervical disc disease defined as neck pain of discogenic origin with degeneration…
Read the full statement (249 words)
The Spinal USA Interbody Fusion Device is indicated for intervertebral body fusion of the spine in skeletally mature patients. The device system is designed for use with autograft to facilitate fusion. One device is used per intervertebral space.
The Spinal USA Interbody Fusion Device ACIF System is intended for use in the cervical spine, from C3 to T1, for the treatment of cervical disc disease defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The cervical device is to be used with supplemental fixation and autogenous bone graft. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral fusion device.
The Spinal USA Interbody Fusion Device ALIF, PLIF, TLIF System are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to SI, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The lumbar device is to be used with supplemental fixation and autogenuos bone graft. Patients should have at least six months of non-operative treatment prior to treatment with a lumbar intervertebral fusion device.
The Spinal USA Interbody Device RPIF System is intended to be used only in anterior procedures in which an ALIF device of the same height is implanted. The RPIF device is not meant for stand alone use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080314 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080314: Spinal Usa Interbody Fusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080314
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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