510(k) · Cleared
Recalled · Class II · 2018Omega LIF System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Amendia, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Aug 10, 2015 after a 173-day review. The FDA summary names no predicate by number. 24 later devices descend from it. It has been recalled once.
- Decided
- Aug 10, 2015
- Review
- 173 days
- Class
- Class II
- Product code
- MAX
- Recalls
- 1
- Predicates
- 0
24 later devices descend from it, 3 citing it directly.
- This deviceK150395 Omega LIF SystemAmendia, Inc. · 2015
- Descendant · cites it directly · 12 of its ownK183184 FlareHawk Interbody Fusion SystemIntegrity Implants, Inc. · 2019
- Descendant · cites it directly · 8 of its ownK203254 Lucent 3D Spinal SystemSpinal Elements, Inc. · 2021
- Descendant · 2 generations on · 5 of its ownK203038 Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 2021
- Descendant · 2 generations on · 4 of its ownK222833 Ventana™ C Spinal SystemSpinal Elements, Inc. · 2023
- Descendant · 2 generations on · 4 of its ownK213355 Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 2022
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K183184FlareHawk Interbody Fusion SystemIntegrity Implants, Inc. · 2019 · cites it directly12descendants
- K203254Lucent 3D Spinal SystemSpinal Elements, Inc. · 2021 · cites it directly8descendants
- K203038Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 2021 · 2 generations on5descendants
- K222833Ventana™ C Spinal SystemSpinal Elements, Inc. · 2023 · 2 generations on4descendants
- K213355Toro-L Interbody Fusion SystemIntegrity Implants, Inc. · 2022 · 2 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K150395 | Omega LIF System | Amendia, Inc. | 2015 | — |
| +1 | K183184 | FlareHawk Interbody Fusion System | Integrity Implants, Inc. | 2019 | — |
| +1 | K203254 | Lucent 3D Spinal System | Spinal Elements, Inc. | 2021 | — |
| +2 | K203038 | Toro-L Interbody Fusion System | Integrity Implants, Inc. | 2021 | — |
| +2 | K222833 | Ventana™ C Spinal System | Spinal Elements, Inc. | 2023 | — |
| +2 | K213355 | Toro-L Interbody Fusion System | Integrity Implants, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 5 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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?
The FDA summary names no predicate by number.
What descends from it? (24)
See all 243 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 16, 2018 | Class II | Z-1912-2018 | Labeling mix-ups | Omega LIF interbody implants labeled as having 11 degrees of lordosis was assembled using components manufactured with 4 degrees of lordosis. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K183184 (Integrity Implants, Inc., 2019) has gone furthest, with 12 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. 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 Omega LIF device is indicated for intervertebral body spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L.2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level. Omega LIF implants are to be used with autogenous bone graft and supplemental fixation. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
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/K150395 · printed Nov 4, 2026
Cite this page
510(k) Report. “K150395: Omega LIF System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K150395
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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