510(k) · Cleared
ClearedSpinefrontier Dorado VBR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinefrontier, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Nov 1, 2007 as substantially equivalent to P960025 (Depuy Spine, Inc., 1999) and 1 other predicate after a 77-day review. Its family tree reaches back 1 generation to 1996. 17 later devices descend from it.
- Decided
- Nov 1, 2007
- Review
- 77 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to P950002 (1996). 2 ancestors in all. 17 later devices descend from it, 3 citing it directly.
- Root · 1 generation backP950002 Bak Interbody Fusion SystemZimmer Spine, Inc. · 1996
- This deviceK072289 Spinefrontier Dorado VBRSpinefrontier, Inc. · 2007
- Descendant · cites it directly · 15 of its ownK092815 S-Lif Intervertebral Body Fusion DeviceSpinefrontier, Inc. · 2010 · Recalled
- Descendant · cites it directly · 15 of its ownK091638 Dorado Wide Intervertebral Body Cage, Models: IM2010-IM2031Spinefrontier, Inc. · 2009
- Descendant · cites it directly · 14 of its ownK111553 Spinefrontier Lumbar Ibf SystemSpinefrontier, Inc. · 2011
- Descendant · 2 generations on · 8 of its ownK160976 Altus Spine Interbody Fusion SystemAltus Partners, LLC · 2017
- Descendant · 3 generations on · 6 of its ownK170512 Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC · 2017
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K092815S-Lif Intervertebral Body Fusion DeviceSpinefrontier, Inc. · 2010 · cites it directly15descendants
- K091638Dorado Wide Intervertebral Body Cage, Models: IM2010-IM2031Spinefrontier, Inc. · 2009 · cites it directly15descendants
- K111553Spinefrontier Lumbar Ibf SystemSpinefrontier, Inc. · 2011 · cites it directly14descendants
- K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC · 2017 · 2 generations on8descendants
- K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC · 2017 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | P950002 | Bak Interbody Fusion System | Zimmer Spine, Inc. | 1996 | — |
| 0 (this device) | K072289 | Spinefrontier Dorado VBR | Spinefrontier, Inc. | 2007 | — |
| +1 | K092815 | S-Lif Intervertebral Body Fusion Device | Spinefrontier, Inc. | 2010 | 6 |
| +1 | K091638 | Dorado Wide Intervertebral Body Cage, Models: IM2010-IM2031 | Spinefrontier, Inc. | 2009 | — |
| +1 | K111553 | Spinefrontier Lumbar Ibf System | Spinefrontier, Inc. | 2011 | — |
| +2 | K160976 | Altus Spine Interbody Fusion System | Altus Partners, LLC | 2017 | — |
| +3 | K170512 | Altus Spine Titanium Interbody Fusion System | Altus Partners, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle ScrewsSummary page 1…(21 CFR 888.3080), Class 11,Product Code MAX 3. Predicate Device(s) P960025 - Saber Lumbar I/F Cage and Jaguar Lumbar I/F Cage P950002 - BAK Interbody Fusion System with Instrumentation 4… | 1999 |
| * | P950002 | Bak Interbody Fusion SystemSummary page 1…ct Code MAX 3. Predicate Device(s) P960025 - Saber Lumbar I/F Cage and Jaguar Lumbar I/F Cage P950002 - BAK Interbody Fusion System with Instrumentation 4. Device Description The DORADOTm Intervertebral Body Cage… | 1996 |
What descends from it? (17)
See all 173 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 MAX devicesMAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 DORADOTM Intervertebral Body Cage is a spinal intervertebral body cage intended for a posterior approach and uses autogenous bone graft in patients with degenerative disc disease (DDD) at one or two spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolithesis at the involved level(s). The SpineFrontier DORADOTM Intervertebral Body Cage is intended to be used with supplemental spinal fixation system(s)…
Read the full statement (107 words)
The DORADOTM Intervertebral Body Cage is a spinal intervertebral body cage intended for a posterior approach and uses autogenous bone graft in patients with degenerative disc disease (DDD) at one or two spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolithesis at the involved level(s). The SpineFrontier DORADOTM Intervertebral Body Cage is intended to be used with supplemental spinal fixation system(s) (Example: Posterior Pedicle Screw).
Degenerative disc disease is defined as discogenic back pain with degeneration of the disc confirmed by history or radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072289 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072289: Spinefrontier Dorado VBR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072289
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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