510(k) · Cleared
ClearedNovel Alif Spinal Spacer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alphatec Spine, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Apr 22, 2009 after a 30-day review. The FDA summary names no predicate by number. 134 later devices descend from it.
- Decided
- Apr 22, 2009
- Review
- 30 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 0
134 later devices descend from it, 7 citing it directly.
- This deviceK090782 Novel Alif Spinal Spacer SystemAlphatec Spine, Inc. · 2009
- Descendant · cites it directly · 112 of its ownK102402 Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer SystemAlphatec Spine, Inc. · 2011 · Recalled
- Descendant · cites it directly · 111 of its ownK181453 ATEC ALIF Spacer SystemAlphatec Spine, Inc. · 2018
- Descendant · cites it directly · 110 of its ownK182746 ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018
- Descendant · 2 generations on · 99 of its ownK183705 IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019
- Descendant · 2 generations on · 78 of its ownK191311 ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019
Showing 5 of 134 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 134 · See all- K102402Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer SystemAlphatec Spine, Inc. · 2011 · cites it directly112descendants
- K181453ATEC ALIF Spacer SystemAlphatec Spine, Inc. · 2018 · cites it directly111descendants
- K182746ATEC ALIF and LLIF Spacer SystemAlphatec Spine, Inc. · 2018 · cites it directly110descendants
- K183705IdentiTi Porous Ti Interbody SystemAlphatec Spine, Inc. · 2019 · 2 generations on99descendants
- K191311ATEC Lateral Interbody SystemAlphatec Spine, Inc. · 2019 · 2 generations on78descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K090782 | Novel Alif Spinal Spacer System | Alphatec Spine, Inc. | 2009 | — |
| +1 | K102402 | Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer System | Alphatec Spine, Inc. | 2011 | 1 |
| +1 | K181453 | ATEC ALIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| +1 | K182746 | ATEC ALIF and LLIF Spacer System | Alphatec Spine, Inc. | 2018 | — |
| +2 | K183705 | IdentiTi Porous Ti Interbody System | Alphatec Spine, Inc. | 2019 | — |
| +2 | K191311 | ATEC Lateral Interbody System | Alphatec Spine, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 5 | 0 |
| 2019 | 7 | 0 |
| 2020 | 11 | 0 |
| 2021 | 8 | 0 |
| 2022 | 13 | 0 |
| 2023 | 21 | 0 |
| 2024 | 20 | 0 |
| 2025 | 22 | 0 |
| 2026 | 22 | 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? (134)
See all 1347 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102402 | Solus Anterior Lumbar Interbody Fusion (Alif) Spinal Spacer System | 2011 | 112 |
| K181453 | ATEC ALIF Spacer System | 2018 | 111 |
| K182746 | ATEC ALIF and LLIF Spacer System | 2018 | 110 |
| K113540 | Reliance Lumbar Ibf System | 2012 | 12 |
| K211873 | PSX Interbody System | 2021 | 11 |
| K162986 | SPIRA Open Matrix ALIF | 2017 | 11 |
| K180724 | SPIRA Open Matrix LLIF | 2018 | 10 |
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, K102402 (Alphatec Spine, Inc., 2011) has gone furthest, with 112 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. 2009, 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?
When used as an Intervertebral Body Fusion device, the Novel ALIF Spinal Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-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 1 spondylolisthesis or retrolisthesis at the…
Read the full statement (185 words)
When used as an Intervertebral Body Fusion device, the Novel ALIF Spinal Spacer System is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-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 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. The Novel ALIF Spinal Spacer System is to be used with a supplemental fixation system and autogenous bone graft.
When used as a Vertebral Body Replacement device, the Novel ALIF Spinal Spacer System is intended for use in the thoracolumbar spine (Tl-L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e. fracture). The Novel ALIF Spinal Spacer System is intended for use with supplemental spinal fixation system and allogenous bone graft. Specifically-the Novel ALIF Spinal Spacer System is to be used with Alphatec Zodiac Polyaxial Spinal Fixation System or the Alphatec Mirage Top Tightening Spinal System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090782 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090782: Novel Alif Spinal Spacer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090782
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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