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 Jun 19, 2020 as substantially equivalent to K142504 (Spinefrontier, Inc., 2015) after a 224-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Jun 19, 2020
- Review
- 224 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to P950002 (1996). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backP950002 Bak Interbody Fusion SystemZimmer Spine, Inc. · 1996
- 4 generations backK072289 Spinefrontier Dorado VBRSpinefrontier, Inc. · 2007
- 3 generations backK091638 Dorado Wide Intervertebral Body Cage, Models: IM2010-IM2031Spinefrontier, Inc. · 2009
- 2 generations backK111553 Spinefrontier Lumbar Ibf SystemSpinefrontier, Inc. · 2011
- 1 generation backK142504 SpineFrontier Lumbar Interbody Fusion Device SystemSpinefrontier, Inc. · 2015
- This deviceK193106 SpineFrontier Lumbar Interbody Fusion Device SystemSpinefrontier, Inc. · 2020
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | P950002 | Bak Interbody Fusion System | Zimmer Spine, Inc. | 1996 | — |
| −4 | K072289 | Spinefrontier Dorado VBR | Spinefrontier, Inc. | 2007 | — |
| −3 | K091638 | Dorado Wide Intervertebral Body Cage, Models: IM2010-IM2031 | Spinefrontier, Inc. | 2009 | — |
| −2 | K111553 | Spinefrontier Lumbar Ibf System | Spinefrontier, Inc. | 2011 | — |
| −1 | K142504 | SpineFrontier Lumbar Interbody Fusion Device System | Spinefrontier, Inc. | 2015 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K142504 | SpineFrontier Lumbar Interbody Fusion Device SystemSummary page 5…try • Principles of operation Table 5-1 Predicate Devices 510k Number Trade or Proprietary or Model Name Manufacturer Designation K142504 SpineFrontier Lumbar Interbody Fusion SpineFrontier, Inc. Primary Device System PER… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- 2 of the 11 ancestors have a recall of any class.
- 1 other device also cites its predicate K142504.
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. 2020, 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 lnterbody 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 (140 words)
The SpineFrontier Lumbar lnterbody 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 Interbody 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/K193106 · printed Nov 5, 2026
Cite this page
510(k) Report. “K193106: SpineFrontier Lumbar Interbody Fusion Device System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K193106
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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