510(k) · Decided
DecidedElite Ibf
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Innova Spinal Technologies, LLC · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Mar 6, 2014 after a 114-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 17 later devices descend from it.
- Decided
- Mar 6, 2014
- Review
- 114 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 0
17 later devices descend from it, 2 citing it directly.
- This deviceK133459 Elite IbfInnova Spinal Technologies, LLC · 2014
- Descendant · cites it directly · 9 of its ownK162879 Elite Expandable Interbody Fusion DeviceSpineology, Inc. · 2017
- Descendant · 2 generations on · 8 of its ownK171425 Concorde LiftMedos International SARL · 2017 · Recalled
- Descendant · cites it directly · 6 of its ownK150954 Elite L Expandable Lumbar Fusion SystemInnova Spinal Technologies, LLC · 2015
- Descendant · 3 generations on · 5 of its ownK190708 AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2019
- Descendant · 2 generations on · 5 of its ownK160074 Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc. · 2016
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K162879Elite Expandable Interbody Fusion DeviceSpineology, Inc. · 2017 · cites it directly9descendants
- K171425Concorde LiftMedos International SARL · 2017 · 2 generations on8descendants
- K150954Elite L Expandable Lumbar Fusion SystemInnova Spinal Technologies, LLC · 2015 · cites it directly6descendants
- K190708AccelFix Lumbar Interbody Fusion Cage SystemL&K BIOMED Co., Ltd. · 2019 · 3 generations on5descendants
- K160074Rampart D Lumbar Interbody Fusion DeviceSpineology, Inc. · 2016 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K133459 | Elite Ibf | Innova Spinal Technologies, LLC | 2014 | — |
| +1 | K162879 | Elite Expandable Interbody Fusion Device | Spineology, Inc. | 2017 | — |
| +2 | K171425 | Concorde Lift | Medos International SARL | 2017 | 2 |
| +1 | K150954 | Elite L Expandable Lumbar Fusion System | Innova Spinal Technologies, LLC | 2015 | — |
| +3 | K190708 | AccelFix Lumbar Interbody Fusion Cage System | L&K BIOMED Co., Ltd. | 2019 | — |
| +2 | K160074 | Rampart D Lumbar Interbody Fusion Device | Spineology, Inc. | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (17)
See all 172 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?
- Of its descendants, K162879 (Spineology, Inc., 2017) has gone furthest, with 9 descendants of its own.
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. 2014, 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 ELITE™ IBF Expandable Lumbar Fusion System is Indicated for use as intervertebral body fusion devices in skeletally mature patients with Degenerative Disc Disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine from L2-S1. Patients should have received a minimum of six months of non-operative treatment prior to surgery. These…
Read the full statement (108 words)
The ELITE™ IBF Expandable Lumbar Fusion System is Indicated for use as intervertebral body fusion devices in skeletally mature patients with Degenerative Disc Disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine from L2-S1. Patients should have received a minimum of six months of non-operative treatment prior to surgery. These patients may also have up to grade I spondylolisthesis or retrolisthesis at the involved level(s). These implants are intended for use with autogenous bone graft and supplemental internal fixation systems such as a pedicle screw or anterior plating system.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K133459 · printed Nov 3, 2026
Cite this page
510(k) Report. “K133459: Elite Ibf.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K133459
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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