510(k) · Cleared
ClearedSpineFrontier Lumbar Interbody Fusion Device 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 May 13, 2015 as substantially equivalent to K111553 (Spinefrontier, Inc., 2011) after a 250-day review. Its family tree reaches back 4 generations to 1996. 4 later devices descend from it.
- Decided
- May 13, 2015
- Review
- 250 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to P950002 (1996). 10 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 4 generations backP950002 Bak Interbody Fusion SystemZimmer Spine, Inc. · 1996
- 3 generations backK072289 Spinefrontier Dorado VBRSpinefrontier, Inc. · 2007
- 2 generations backK091638 Dorado Wide Intervertebral Body Cage, Models: IM2010-IM2031Spinefrontier, Inc. · 2009
- 1 generation backK111553 Spinefrontier Lumbar Ibf SystemSpinefrontier, Inc. · 2011
- This deviceK142504 SpineFrontier Lumbar Interbody Fusion Device SystemSpinefrontier, Inc. · 2015
- Descendant · cites it directly · 2 of its ownK201367 FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc. · 2020
- Descendant · 2 generations on · 1 of its ownK233509 Zavation IBF System, Zavation Varisync Plate System and Varisync…Zavation Medical Products, LLC · 2024
- Descendant · 3 generations on · 0 of its ownK250769 Dakota LP SystemPrecision Spine, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK193106 SpineFrontier Lumbar Interbody Fusion Device SystemSpinefrontier, Inc. · 2020
Most influential descendants
Showing 4 of 4 · See all- K201367FlareHawk TiHawk9 Interbody Fusion SystemIntegrity Implants, Inc. · 2020 · cites it directly2descendants
- K233509Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System…Zavation Medical Products, LLC · 2024 · 2 generations on1descendant
- K250769Dakota LP SystemPrecision Spine, Inc. · 2025 · 3 generations on0descendants
- K193106SpineFrontier Lumbar Interbody Fusion Device SystemSpinefrontier, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | P950002 | Bak Interbody Fusion System | Zimmer Spine, Inc. | 1996 | — |
| −3 | K072289 | Spinefrontier Dorado VBR | Spinefrontier, Inc. | 2007 | — |
| −2 | K091638 | Dorado Wide Intervertebral Body Cage, Models: IM2010-IM2031 | Spinefrontier, Inc. | 2009 | — |
| −1 | K111553 | Spinefrontier Lumbar Ibf System | Spinefrontier, Inc. | 2011 | — |
| 0 (this device) | K142504 | SpineFrontier Lumbar Interbody Fusion Device System | Spinefrontier, Inc. | 2015 | — |
| +1 | K201367 | FlareHawk TiHawk9 Interbody Fusion System | Integrity Implants, Inc. | 2020 | — |
| +2 | K233509 | Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer… | Zavation Medical Products, LLC | 2024 | — |
| +3 | K250769 | Dakota LP System | Precision Spine, Inc. | 2025 | — |
| +1 | K193106 | SpineFrontier Lumbar Interbody Fusion Device System | Spinefrontier, Inc. | 2020 | — |
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 |
|---|---|---|
| 2020 | 2 | 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? (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 |
|---|---|---|---|
| * | K111553 | Spinefrontier Lumbar Ibf SystemSummary page 6…Principles of operation Table 5-1 Predicate Devices 510k Number Trade or Proprietary or Model Manufacturer Type Name K111553 Lumbar Interbody Fusion Device SpineFrontier Primary System K071724,… | 2011 |
| † | K071724 | Lucent | 2007 |
| † | K110632 | Lucent or Lucent Magnum | 2012 |
| † | K130573 | Tyber Medical Interbody System; Acif, Alif, Plif, Tlif, Dlif | 2013 |
What descends from it? (4)
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?
- The line of descent spans 19 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- 2 of the 10 ancestors have a recall of any class.
- Of its descendants, K201367 (Integrity Implants, Inc., 2020) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K111553.
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. 2015, 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, Arena-L, 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 (DDD) at one or two contiguous spinal levels from L2-S1. These DDD patients may…
Read the full statement (141 words)
The SpineFrontier Lumbar Interbody Fusion Device System (Dorado IBC, Dorado PLIFT, Dorado ELIFT, Arena-L, 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 (DDD) at one or two contiguous spinal levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis 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 Intervertebral 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 as stated in the FDA summary.
https://510kreport.com/device/K142504 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142504: SpineFrontier Lumbar Interbody Fusion Device System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142504
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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