510(k) · Cleared
ClearedGuided Lateral Interbody Fusion (Glif) 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 May 19, 2009 as substantially equivalent to K080699 (Alphatec Spine, Inc., 2008) and 1 other predicate after an 89-day review. Its family tree reaches back 2 generations to 2007. 319 later devices descend from it.
- Decided
- May 19, 2009
- Review
- 89 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K071922 (2007). 3 ancestors in all. 319 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK071922 Interplate Interbody Fusion Device, Models C, CGC, L and LGCRsb Spine, LLC · 2007
- 1 generation backK071795 Nuvasive Coroent SystemNuvasive, Inc. · 2007
- This deviceK090425 Guided Lateral Interbody Fusion (Glif) SystemAlphatec Spine, Inc. · 2009
- Descendant · cites it directly · 235 of its ownK140348 Interbody CageEisertech, LLC · 2015
- Descendant · 2 generations on · 224 of its ownK163506 Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or…Vertera, Inc. · 2017
- Descendant · cites it directly · 175 of its ownK100210 TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated · 2010
- Descendant · 2 generations on · 173 of its ownK123997 TRANS1LATERAL Interbody Fusion SystemTrans1, Inc. · 2013
- Descendant · 2 generations on · 171 of its ownK153107 Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™…Choicespine, LP · 2016
Showing 5 of 319 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 319 · See all- K140348Interbody CageEisertech, LLC · 2015 · cites it directly235descendants
- K163506Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique) Lumbar…Vertera, Inc. · 2017 · 2 generations on224descendants
- K100210TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated · 2010 · cites it directly175descendants
- K123997TRANS1LATERAL Interbody Fusion SystemTrans1, Inc. · 2013 · 2 generations on173descendants
- K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP · 2016 · 2 generations on171descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K071922 | Interplate Interbody Fusion Device, Models C, CGC, L and LGC | Rsb Spine, LLC | 2007 | — |
| −1 | K071795 | Nuvasive Coroent System | Nuvasive, Inc. | 2007 | — |
| 0 (this device) | K090425 | Guided Lateral Interbody Fusion (Glif) System | Alphatec Spine, Inc. | 2009 | — |
| +1 | K140348 | Interbody Cage | Eisertech, LLC | 2015 | — |
| +2 | K163506 | Coalesce™ (-Straight, -Convex, -Crescent, -Lateral, -Anterior, or -Oblique)… | Vertera, Inc. | 2017 | — |
| +1 | K100210 | TRANS1 Lateral Intervertebral Fusion Device, T | Trans1 Incorporated | 2010 | — |
| +2 | K123997 | TRANS1LATERAL Interbody Fusion System | Trans1, Inc. | 2013 | — |
| +2 | K153107 | Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice… | Choicespine, LP | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 8 | 0 |
| 2018 | 8 | 0 |
| 2019 | 15 | 0 |
| 2020 | 25 | 0 |
| 2021 | 25 | 0 |
| 2022 | 38 | 0 |
| 2023 | 44 | 0 |
| 2024 | 59 | 0 |
| 2025 | 50 | 0 |
| 2026 | 41 | 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? (2)
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 |
|---|---|---|---|
| * | K080699 | Novel Spinal Spacer SystemSummary page 2…al Equivalence: Data was provided which demonstrated the Guided Lateral Interbody Fusion (GLIF) System to be substantially equivalent to the Novel Spinal Spacer System (K080699) and the Nuvasive CoRoent (K071795). The substantial equivalence is based upon equivalence in indications for use, design, materi… | 2008 |
| * | K071795 | Nuvasive Coroent SystemSummary page 2…which demonstrated the Guided Lateral Interbody Fusion (GLIF) System to be substantially equivalent to the Novel Spinal Spacer System (K080699) and the Nuvasive CoRoent (K071795). The substantial equivalence is based upon equivalence in indications for use, design, material and function. Performance Data:… | 2007 |
What descends from it? (319)
See all 3192 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 2 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K140348 (Eisertech, LLC, 2015) has gone furthest, with 235 descendants of its own.
- 10 other devices also cite its predicate K080699.
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 Guided Lateral Interbody Fusion (GLIF) 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…
Read the full statement (185 words)
When used as an intervertebral body'fusion device, the Guided Lateral Interbody Fusion (GLIF) 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 GLIF System is to be used with a supplemental fixation system and autogenous bone graft.
When used as a vertebral body replacement device, the Guided Lateral Interbody Fusion (GLIF) system is intended for use in the thoracolumbar spine (Ti -L5) to replace a collapsed, damaged or unstable vertebral body due to tumor or trauma (i.e. fracture). The GLIF System is intended for use with supplemental spinal fixation system. Specifically the GLIF System is to be used with Alphatee Zodiac Polyaxial Spinal Fixation System or the Alphatec Mirage Top Tightening Spinal System. Furthermore the GLIF System is intended for use with allograft.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090425 · printed Nov 5, 2026
Cite this page
510(k) Report. “K090425: Guided Lateral Interbody Fusion (Glif) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K090425
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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