510(k) · Cleared
ClearedDorado Wide Intervertebral Body Cage, Models: IM2010-IM2031
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 Sep 14, 2009 as substantially equivalent to K072289 (Spinefrontier, Inc., 2007) and 1 other predicate after a 102-day review. Its family tree reaches back 2 generations to 1996. 15 later devices descend from it.
- Decided
- Sep 14, 2009
- Review
- 102 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to P950002 (1996). 3 ancestors in all. 15 later devices descend from it, 1 citing it directly.
- Root · 2 generations backP950002 Bak Interbody Fusion SystemZimmer Spine, Inc. · 1996
- 1 generation backK072289 Spinefrontier Dorado VBRSpinefrontier, Inc. · 2007
- This deviceK091638 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
- Descendant · 2 generations on · 4 of its ownK142504 SpineFrontier Lumbar Interbody Fusion Device SystemSpinefrontier, Inc. · 2015
- Descendant · 3 generations on · 2 of its ownK201367 FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc. · 2020
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- 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
- K142504SpineFrontier Lumbar Interbody Fusion Device SystemSpinefrontier, Inc. · 2015 · 2 generations on4descendants
- K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc. · 2020 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | P950002 | Bak Interbody Fusion System | Zimmer Spine, Inc. | 1996 | — |
| −1 | K072289 | Spinefrontier Dorado VBR | Spinefrontier, Inc. | 2007 | — |
| 0 (this device) | 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 | — |
| +2 | K142504 | SpineFrontier Lumbar Interbody Fusion Device System | Spinefrontier, Inc. | 2015 | — |
| +3 | K201367 | FlareHawk TiHawk9 Interbody Fusion System | Integrity Implants, Inc. | 2020 | — |
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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K072289 | Spinefrontier Dorado VBRSummary page 1…Lumbar, (21 CFR.888.3080), Class II Product.Code: MAX' 3. Predicate Devices K072289 - SpineFrontier Inc., Dorado Intervertebral Body Cage P9,60025 - Saber Lumbar I/F Cage and Jaguar Lumbar IIF Cage… | 2007 |
| * | P960025 | Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws | 1999 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111553 | Spinefrontier Lumbar Ibf System | 2011 | 14 |
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?
- The line of descent spans 13 years and passes through 2 companies; a new generation was cleared every 11.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K111553 (Spinefrontier, Inc., 2011) has gone furthest, with 14 descendants of its own.
- 2 other devices also cite its predicate K072289.
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. 2009, 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 DORADO Wide 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 contiguous 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 DORADO Wide Intervertebral Body Cage is intended to be used with supplemental spinal…
Read the full statement (110 words)
The DORADO Wide 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 contiguous 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 DORADO Wide 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/K091638 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091638: Dorado Wide Intervertebral Body Cage, Models: IM2010-IM2031.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091638
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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