510(k) · Cleared
ClearedTRANS1LATERAL Interbody Fusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trans1, Inc. · MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cleared on Apr 1, 2013 as substantially equivalent to K100210 (Trans1 Incorporated, 2010) after a 96-day review. Its family tree reaches back 11 generations to 1984. 173 later devices descend from it.
- Decided
- Apr 1, 2013
- Review
- 96 days
- Class
- Class II
- Product code
- MAX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K841189 (1984). 38 ancestors in all. 173 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 7 generations between
- 3 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK073177 Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology · 2008 · Recalled
- 1 generation backK100210 TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated · 2010
- This deviceK123997 TRANS1LATERAL Interbody Fusion SystemTrans1, Inc. · 2013
- Descendant · cites it directly · 171 of its ownK153107 Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™…Choicespine, LP · 2016
- Descendant · 2 generations on · 161 of its ownK162103 Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™…Choicespine, LP · 2016
- Descendant · 2 generations on · 116 of its ownK171686 Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine · 2017
- Descendant · 3 generations on · 104 of its ownK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
- Descendant · 4 generations on · 102 of its ownK192018 Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS…Titan Spine, Inc. · 2019 · Recalled
Show all 11 generations
- Root · 11 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 9 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 8 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 7 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 6 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 5 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 4 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 3 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 2 generations backK073177 Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology · 2008 · Recalled
- 1 generation backK100210 TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated · 2010
- This deviceK123997 TRANS1LATERAL Interbody Fusion SystemTrans1, Inc. · 2013
Showing 5 of 173 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 173 · See all- K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP · 2016 · cites it directly171descendants
- K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine…Choicespine, LP · 2016 · 2 generations on161descendants
- K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine · 2017 · 2 generations on116descendants
- K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion Device…Titan Spine, Inc. · 2019 · 3 generations on104descendants
- K192018Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS Hyperlordotic…Titan Spine, Inc. · 2019 · 4 generations on102descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −10 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −9 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −8 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −7 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −6 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −5 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −4 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −3 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −2 | K073177 | Pioneer Intervertebral Fusion Device System | Pioneer Surgical Technology | 2008 | 1 |
| −1 | K100210 | TRANS1 Lateral Intervertebral Fusion Device, T | Trans1 Incorporated | 2010 | — |
| 0 (this device) | K123997 | TRANS1LATERAL Interbody Fusion System | Trans1, Inc. | 2013 | — |
| +1 | K153107 | Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice… | Choicespine, LP | 2016 | — |
| +2 | K162103 | Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice… | Choicespine, LP | 2016 | — |
| +2 | K171686 | Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) System | Choicespine | 2017 | — |
| +3 | K183557 | Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion… | Titan Spine, Inc. | 2019 | 3 |
| +4 | K192018 | Endoskeleton TA Interbody Fusion Device, Endoskeleton TAS and TAS… | Titan Spine, Inc. | 2019 | 4 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 6 | 0 |
| 2018 | 4 | 0 |
| 2019 | 10 | 0 |
| 2020 | 9 | 0 |
| 2021 | 13 | 0 |
| 2022 | 20 | 0 |
| 2023 | 18 | 0 |
| 2024 | 31 | 0 |
| 2025 | 32 | 0 |
| 2026 | 28 | 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 |
|---|---|---|---|
| * | K100210 | TRANS1 Lateral Intervertebral Fusion Device, TSummary page 1…I VEO Classification: 888.3080: Intervertebral Fusion Device (MAX) Legally Marketed Equivalent Device: TranS I Lateral Interbody Fusion Device: K 1002 10 Indications and Intended use: VEO is indicated for spinal fusion procedures in skeletally mature patients with degenerative dis… | 2010 |
What descends from it? (173)
See all 1732 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 29 years and passes through 10 companies; a new generation was cleared every 1.7 years on median.
- 6 of the 38 ancestors have a recall of any class.
- Of its descendants, K153107 (Choicespine, LP, 2016) has gone furthest, with 171 descendants of its own.
- 2 other devices also cite its predicate K100210.
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. 2013, 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?
VEO 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 I spondylolisthesis or retrolisthesis at the involved level(s). These patients should have had six months of non-operative treatment. VEO is designed to be used with autogenous graft and supplemental spinal fixation that is cleared for use in the lumbar spine.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123997 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123997: TRANS1LATERAL Interbody Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123997
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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