510(k) Report

510(k) · Cleared

Cleared

TRANS1 Lateral Intervertebral Fusion Device, T

K100210510(k) TraditionalCleared Aug 26, 2010213-day reviewClass II21 CFR 888.3080

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Trans1 Incorporated · MAX Intervertebral Fusion Device With Bone Graft, Lumbar

Cleared on Aug 26, 2010 as substantially equivalent to K073177 (Pioneer Surgical Technology, 2008) and 1 other predicate after a 213-day review. Its family tree reaches back 10 generations to 1984. 175 later devices descend from it.

Decided
Aug 26, 2010
Review
213 days
Class
Class II
Product code
MAX
Recalls
None
Predicates
2

Its longest line of descent runs back 10 generations to K841189 (1984). 37 ancestors in all. 175 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2008: 1 other ancestor2007: 5 other ancestors2006: 1 other ancestor2001: 4 other ancestors2005: 1 other ancestor1999: 2 other ancestors1996: 1 other ancestor2004: 4 other ancestors2002: 4 other ancestors2003: 2 other ancestors2000: 1 other ancestor2016: 3 descendants cleared2013: 1 descendant cleared2019: 10 descendants cleared2017: 6 descendants cleared2018: 4 descendants cleared2021: 13 descendants cleared2022: 20 descendants cleared2025: 32 descendants cleared2020: 9 descendants cleared2023: 18 descendants cleared2024: 31 descendants cleared2026: 28 descendants clearedK841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001×2: 2 generations cleared close together, K022793 (2003), K031757 (2003) ×2: 2 generations cleared close together, K041888 (2004), K042930 (2004) K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K073177 · Pioneer Intervertebral Fusion Device System · Pioneer Surgical Technology · 2008 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 6 other ancestors3 generations back: 6 other ancestors4 generations back: 4 other ancestors5 generations back: 5 other ancestors6 generations back: 4 other ancestors7 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 10 descendants4 generations forward: 22 descendants5 generations forward: 21 descendants6 generations forward: 25 descendants7 generations forward: 35 descendants8 generations forward: 35 descendants9 generations forward: 15 descendants10 generations forward: 4 descendants11 generations forward: 1 descendant K073177 · Pioneer Intervertebral Fusion Device System · Pioneer Surgical Technology · 2008 · recalledK072120 · Paramount Intervertebral Body Fusion Device · Innovative Spinal Technologies, Inc. · 2007K062759 · Paramount VBR System · Innovative Spinal Technologies, Inc. · 2007K042930 · Spacevision Cage System · Spine Vision, Inc. · 2004K041888 · Curved Peek Tetris Spinal Implant · Signus Medizintechnik GmbH · 2004K031757 · Peek Tetris Spinal Implant · Signus Medical, LLC · 2003K022793 · Tetris Spinal Implant · Signus Medical, LLC · 2003K003043 · Surgical Titanium Mesh System · Depuyacromed · 2001K990148 · Stackable Cage System · Depuy Motech Acromed · 1999K841189 · Oec/Rezaian Spinal Fixator · Orthopedic Equipment Co., Inc. · 1984−10−50+5+10
  1. Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 6 generations between
  3. 3 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  4. 2 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  5. 1 generation backK073177 Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology · 2008 · Recalled
  6. This deviceK100210 TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated · 2010
  7. Descendant · cites it directly · 173 of its ownK123997 TRANS1LATERAL Interbody Fusion SystemTrans1, Inc. · 2013
  8. Descendant · cites it directly · 171 of its ownK153107 Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™…Choicespine, LP · 2016
  9. Descendant · 2 generations on · 161 of its ownK162103 Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™…Choicespine, LP · 2016
  10. Descendant · 2 generations on · 116 of its ownK171686 Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine · 2017
  11. Descendant · 3 generations on · 104 of its ownK183557 Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS…Titan Spine, Inc. · 2019 · Recalled
Show all 10 generations
  1. Root · 10 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
  2. 9 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
  3. 8 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
  4. 7 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
  5. 6 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
  6. 5 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
  7. 4 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
  8. 3 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
  9. 2 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
  10. 1 generation backK073177 Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology · 2008 · Recalled
  11. This deviceK100210 TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated · 2010

Showing 5 of 175 descendants. See all descendants

Descendants cleared per year

2013: 12016: 32017: 62018: 42019: 102020: 92021: 132022: 202023: 182024: 312025: 322026: 28
2013high 32 (2025) · low 0 (2014)2026

Most influential descendants

Showing 5 of 175 · See all
  • K123997TRANS1LATERAL Interbody Fusion SystemTrans1, Inc. · 2013 · cites it directly173descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K841189Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc.1984—
−9K990148Stackable Cage SystemDepuy Motech Acromed1999—
−8K003043Surgical Titanium Mesh SystemDepuyacromed2001—
−7K022793Tetris Spinal ImplantSignus Medical, LLC2003—
−6K031757Peek Tetris Spinal ImplantSignus Medical, LLC2003—
−5K041888Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH2004—
−4K042930Spacevision Cage SystemSpine Vision, Inc.2004—
−3K062759Paramount VBR SystemInnovative Spinal Technologies, Inc.2007—
−2K072120Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc.2007—
−1K073177Pioneer Intervertebral Fusion Device SystemPioneer Surgical Technology20081
0 (this device)K100210TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated2010—
+1K123997TRANS1LATERAL Interbody Fusion SystemTrans1, Inc.2013—
+1K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice…Choicespine, LP2016—
+2K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice…Choicespine, LP2016—
+2K171686Choice Spine Hawkeye™ Vertebral Body Replacement (VBR) SystemChoicespine2017—
+3K183557Endoskeleton® TA Interbody Fusion Device, Endoskeleton® TAS Interbody Fusion…Titan Spine, Inc.20193

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
199920
200010
200140
200240
200320
200440
200510
200610
200750
200810
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201630
201760
201840
2019100
202090
2021130
2022200
2023180
2024310
2025320
2026280
FIG. 1 — Lineage of K100210, 1984–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K203714 NuVasive Thoracolumbar Interbody Systems…score 102.5 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K073177Pioneer Intervertebral Fusion Device System
Summary page 1
…AX) Predicate Device: *Pioneer Surgical Technology: Pioneer Intervertebral Body Fusion System (K073177) *Aiphatec Spinte, Inc: Guided Lateral Interbody Fusion (GLIF) System…
Pioneer Surgical Technology20081
*K090425Guided Lateral Interbody Fusion (Glif) System
Summary page 1
…System (K073177) *Aiphatec Spinte, Inc: Guided Lateral Interbody Fusion (GLIF) System (K090425) Indications and Intended use: The TranS1 Lateral Interbody Fusion Device is indicated for spinal fusion procedures in skeletall…
Alphatec Spine, Inc.2009—

Also cleared against K073177: 11 other devices →

What descends from it? (175)

See all 175

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K123997TRANS1LATERAL Interbody Fusion SystemTrans1, Inc.2013173
K153107Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine VEO™…Choicespine, LP2016171
K153665Prow Fusion-LNlt Spine, Ltd.20160

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 26 years and passes through 9 companies; a new generation was cleared every 1.7 years on median.
  • 6 of the 37 ancestors have a recall of any class.
  • Of its descendants, K123997 (Trans1, Inc., 2013) has gone furthest, with 173 descendants of its own.
  • 11 other devices also cite its predicate K073177.

How does its category compare?

All MAX devices

MAX Intervertebral Fusion Device With Bone Graft, Lumbar: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · MAX

29in 2025

2007: 72008: 352009: 312010: 292011: 492012: 482013: 582014: 582015: 532016: 642017: 762018: 642019: 602020: 562021: 532022: 412023: 302024: 382025: 292026 (partial year): 18
2007high 76 (2017) · low 7 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MAX

85in 2025

2007: 86 days median2008: 88 days median2009: 102 days median2010: 137 days median2011: 98 days median2012: 69 days median2013: 102 days median2014: 115 days median2015: 113 days median2016: 124 days median2017: 116 days median2018: 114 days median2019: 131 days median2020: 106 days median2021: 109 days median2022: 95 days median2023: 87 days median2024: 91 days median2025: 85 days median2026 (partial year): 95 days median
2007high 137 (2010) · low 69 (2012)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MAX

5in 2025

2008: 22009: 92011: 32012: 11, 1 Class I2014: 32015: 12016: 62017: 12018: 42019: 12022: 12024: 12025: 5
2007high 11 (2012) · low 0 (2007)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · MAX

811in 2025

2007: 122008: 192009: 902010: 1542011: 2012012: 3272013: 3802014: 3662015: 5242016: 6472017: 5962018: 6162019: 6992020: 6402021: 6222022: 6182023: 5762024: 7292025: 811
2007high 811 (2025) · low 12 (2007)2025

MAUDE reports naming product code MAX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007786012
20083588219
200931102990
2010291370154
201149983201
2012486911 (1)327
2013581020380
2014581153366
2015531131524
2016641246647
2017761161596
2018641144616
2019601311699
2020561060640
2021531090622
202241951618
202330870576
202438911729
202529855811
202618950—

What is it indicated for?

The TranSi Lateral Interbody Fusion Device is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. ODD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. These ODDD 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 TranS 1 Lateral Interbody Fusion Device is designed to be used with autogenous graft.

Indications for use as stated in the FDA summary.

Also cleared against K073177

11 other devices cite the same predicate.

  • K170643Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics · 2017
  • K150500Px PEEK IBF SystemInnovasis, Inc. · 2015
  • K150521Interbody Fusion (IBF)/Vertebral Body Replacement (VBR) SystemRti Surgical, Inc. Dba Rti Biologics · 2015
  • K133455Crossfuse II Coronal Taper, Crossfuse II HyperlordoticPioneer Surgical Technology, Inc. · 20141 recall
  • K133623C-PLUSPioneer Surgical Technology, Inc. · 2014
  • K120396Reliance Cervical Ibf SystemReliance Medical Systems, LLC · 2012

More from Trans1 Incorporated

9 FDA decisions under this applicant name. See the company

  • K120991TRANS1 Interbody Fusion SystemTrans1 Incorporated · 2012
  • K102334TRANS1 Axialif PlusTrans1 Incorporated · 2011
  • K092124Axialif 2L, Axialif 2-Level System, Axialif Apollo, Axialif IITrans1 Incorporated · 2010
  • K073643TRANS1 Axialif 2-Level or II SystemTrans1 Incorporated · 2008
  • K073515TRANS1 Facet ScrewTrans1 Incorporated · 2008

Recent decisions in MAX

The MAX category page

  • K262646Calibrate MAX System; Calibrate NanoTec MAX System; Calibrate CCX Interbody System; Calibrate NanoTec CCX…Alphatec Spine, Inc. · 2026
  • K261049Scala® TLSpineart SA · 2026
  • K261430TruLift Expandable SystemLife Spine, Inc. · 2026
  • K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2026
  • K261020Symmetrix™ L Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2026

https://510kreport.com/device/K100210 · printed Nov 6, 2026

Cite this page

510(k) Report. “K100210: TRANS1 Lateral Intervertebral Fusion Device, T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100210

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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