510(k) · Cleared
ClearedSpinefrontier Lumbar Ibf System
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 28, 2011 as substantially equivalent to K072289 (Spinefrontier, Inc., 2007) and 3 other predicates after a 117-day review. Its family tree reaches back 3 generations to 1996. 14 later devices descend from it.
- Decided
- Sep 28, 2011
- Review
- 117 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to P950002 (1996). 9 ancestors in all. 14 later devices descend from it, 2 citing it directly.
- Root · 3 generations backP950002 Bak Interbody Fusion SystemZimmer Spine, Inc. · 1996
- 2 generations backK072289 Spinefrontier Dorado VBRSpinefrontier, Inc. · 2007
- 1 generation backK091638 Dorado Wide Intervertebral Body Cage, Models: IM2010-IM2031Spinefrontier, Inc. · 2009
- This deviceK111553 Spinefrontier Lumbar Ibf SystemSpinefrontier, Inc. · 2011
- Descendant · cites it directly · 8 of its ownK160976 Altus Spine Interbody Fusion SystemAltus Partners, LLC · 2017
- Descendant · 2 generations on · 6 of its ownK170512 Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC · 2017
- Descendant · cites it directly · 4 of its ownK142504 SpineFrontier Lumbar Interbody Fusion Device SystemSpinefrontier, Inc. · 2015
- Descendant · 2 generations on · 2 of its ownK201367 FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc. · 2020
- Descendant · 2 generations on · 2 of its ownK171329 Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC · 2017
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K160976Altus Spine Interbody Fusion SystemAltus Partners, LLC · 2017 · cites it directly8descendants
- K170512Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC · 2017 · 2 generations on6descendants
- K142504SpineFrontier Lumbar Interbody Fusion Device SystemSpinefrontier, Inc. · 2015 · cites it directly4descendants
- K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc. · 2020 · 2 generations on2descendants
- K171329Altus Spine Titanium Interbody Fusion SystemAltus Partners, LLC · 2017 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | P950002 | Bak Interbody Fusion System | Zimmer Spine, Inc. | 1996 | — |
| −2 | K072289 | Spinefrontier Dorado VBR | Spinefrontier, Inc. | 2007 | — |
| −1 | K091638 | Dorado Wide Intervertebral Body Cage, Models: IM2010-IM2031 | Spinefrontier, Inc. | 2009 | — |
| 0 (this device) | K111553 | Spinefrontier Lumbar Ibf System | Spinefrontier, Inc. | 2011 | — |
| +1 | K160976 | Altus Spine Interbody Fusion System | Altus Partners, LLC | 2017 | — |
| +2 | K170512 | Altus Spine Titanium Interbody Fusion System | Altus Partners, LLC | 2017 | — |
| +1 | K142504 | SpineFrontier Lumbar Interbody Fusion Device System | Spinefrontier, Inc. | 2015 | — |
| +2 | K201367 | FlareHawk TiHawk9 Interbody Fusion System | Integrity Implants, Inc. | 2020 | — |
| +2 | K171329 | 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 |
| 2007 | 4 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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…Frontier Lumbar IBF System. These modifications do not alter the fundamental technology of the predicate device or the devices' intended use. K072289 - SpineFrontier Inc., Dorado Intervertebral Body Cage K091638 - SpineFrontier Inc., Dorado Wide OBF K092815 - S… | 2007 |
| * | K091638 | Dorado Wide Intervertebral Body Cage, Models: IM2010-IM2031Summary page 1…he fundamental technology of the predicate device or the devices' intended use. K072289 - SpineFrontier Inc., Dorado Intervertebral Body Cage K091638 - SpineFrontier Inc., Dorado Wide OBF K092815 - SpineFrontier Inc., S-LIF IBF K071724 - Spinal Elements, Lucent… | 2009 |
| * | K092815 | S-Lif Intervertebral Body Fusion DeviceSummary page 1…or the devices' intended use. K072289 - SpineFrontier Inc., Dorado Intervertebral Body Cage K091638 - SpineFrontier Inc., Dorado Wide OBF K092815 - SpineFrontier Inc., S-LIF IBF K071724 - Spinal Elements, Lucent 4. Device Description The SpineFronti… | 2010 |
| * | K071724 | LucentSummary page 1…89 - SpineFrontier Inc., Dorado Intervertebral Body Cage K091638 - SpineFrontier Inc., Dorado Wide OBF K092815 - SpineFrontier Inc., S-LIF IBF K071724 - Spinal Elements, Lucent 4. Device Description The SpineFrontier Lumbar IBF System is a spinal intervertebral b… | 2007 |
What descends from it? (14)
See all 142 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?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- 2 of the 9 ancestors have a recall of any class.
- Of its descendants, K160976 (Altus Partners, LLC, 2017) has gone furthest, with 8 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. 2011, 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 SpineFrontier Lumbar Interbody Fusion Device System (Dorado IBC, Dorado PLIFT, Dorado ELIFT, Dorado ALIFT, Dorado TILT, Dorado; TLIFT, Dorado Wide, and Ursa S-LIFT) is intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative, disc disease (ODD) at one or two contiguous spinal levels from L2-S1. These DDD patients…
Read the full statement (142 words)
The SpineFrontier Lumbar Interbody Fusion Device System (Dorado IBC, Dorado PLIFT, Dorado ELIFT, Dorado ALIFT, Dorado TILT, Dorado; TLIFT, Dorado Wide, and Ursa S-LIFT) is intended for intervertebral body fusion of the spine of skeletally mature patients, using autogenous bone graft to facilitate fusion. The device is indicated for use in patients with degenerative, disc disease (ODD) 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).
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.
The SpineFrontier Lumbar Intervettebral Body Fusion Device System is intended to be used with supplemental spinal fixation system(s) cleared 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/K111553 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111553: Spinefrontier Lumbar Ibf System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111553
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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