510(k) Report

510(k) · Cleared

Cleared

TRANS1 Axial Fixaton System

K073514510(k) SpecialCleared Jan 11, 200828-day reviewClass II21 CFR 888.3060

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

Trans1 Incorporated · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Jan 11, 2008 as substantially equivalent to K050965 (Trans1 Incorporated, 2005) and 1 other predicate after a 28-day review. Its family tree reaches back 3 generations to 2000. 62 later devices descend from it.

Decided
Jan 11, 2008
Review
28 days
Class
Class II
Product code
KWQ
Recalls
None
Predicates
2

Its longest line of descent runs back 3 generations to K002371 (2000). 62 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2011: 1 descendant cleared2021: 1 descendant cleared2019: 1 descendant cleared2022: 6 descendants cleared2025: 15 descendants cleared2024: 14 descendants cleared2023: 10 descendants cleared2026: 14 descendants clearedK002371 · K-Centrum Anterior Spinal Fixation System · Spineology, Inc. · 2000K040426 · TRANS1 Axial Fixation System · Trans1, Inc. · 2004K050965 · TRANS1 Axialif System · Trans1 Incorporated · 2005200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 4 descendants4 generations forward: 11 descendants5 generations forward: 20 descendants6 generations forward: 23 descendants7 generations forward: 1 descendant K050965 · TRANS1 Axialif System · Trans1 Incorporated · 2005K040426 · TRANS1 Axial Fixation System · Trans1, Inc. · 2004K002371 · K-Centrum Anterior Spinal Fixation System · Spineology, Inc. · 20000+5
  1. Root · 3 generations backK002371 K-Centrum Anterior Spinal Fixation SystemSpineology, Inc. · 2000
  2. 2 generations backK040426 TRANS1 Axial Fixation SystemTrans1, Inc. · 2004
  3. 1 generation backK050965 TRANS1 Axialif SystemTrans1 Incorporated · 2005
  4. This deviceK073514 TRANS1 Axial Fixaton SystemTrans1 Incorporated · 2008
  5. Descendant · cites it directly · 61 of its ownK102334 TRANS1 Axialif PlusTrans1 Incorporated · 2011
  6. Descendant · 2 generations on · 59 of its ownK203742 IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021
  7. Descendant · 3 generations on · 36 of its ownK220782 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine, Inc. · 2022
  8. Descendant · 4 generations on · 28 of its ownK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022
  9. Descendant · 3 generations on · 16 of its ownK214006 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2022

Showing 5 of 62 descendants. See all descendants

Descendants cleared per year

2011: 12019: 12021: 12022: 62023: 102024: 142025: 152026: 14
2011high 15 (2025) · low 0 (2012)2026

Most influential descendants

Showing 5 of 62 · See all
  • K102334TRANS1 Axialif PlusTrans1 Incorporated · 2011 · cites it directly61descendants
  • K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021 · 2 generations on59descendants
  • K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc. · 2022 · 3 generations on36descendants
  • K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine · 2022 · 4 generations on28descendants
  • K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2022 · 3 generations on16descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K002371K-Centrum Anterior Spinal Fixation SystemSpineology, Inc.2000—
−2K040426TRANS1 Axial Fixation SystemTrans1, Inc.2004—
−1K050965TRANS1 Axialif SystemTrans1 Incorporated2005—
0 (this device)K073514TRANS1 Axial Fixaton SystemTrans1 Incorporated2008—
+1K102334TRANS1 Axialif PlusTrans1 Incorporated2011—
+2K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc.2021—
+3K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System…Alphatec Spine, Inc.2022—
+4K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System…Alphatec Spine2022—
+3K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc.2022—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201110
201910
202110
202260
2023100
2024140
2025150
2026140
FIG. 1 — Lineage of K073514, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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 KWQ? 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 KWQ device

  1. #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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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
*K050965TRANS1 Axialif System
Summary page 1
…21 CFFP 888.1100 Product Code: HRX Predicate Device: TranSl® Axial Fixation System, K050965 and K040426 Intended use: The TranS1® AxiaLIF® System is indicated for patients requiring fusion to treat pseudoarthrosis, unsucc…
Trans1 Incorporated2005—
*K040426TRANS1 Axial Fixation System
Summary page 1
…21 CFFP 888.1100 Product Code: HRX Predicate Device: TranSl® Axial Fixation System, K050965 and K040426 Intended use: The TranS1® AxiaLIF® System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previ…
Trans1, Inc.2004—

What descends from it? (62)

See all 62

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K102334TRANS1 Axialif PlusTrans1 Incorporated201161

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 8 years and passes through 3 companies; a new generation was cleared every 2.6 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K102334 (Trans1 Incorporated, 2011) has gone furthest, with 61 descendants of its own.

How does its category compare?

All KWQ devices

KWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · KWQ

7in 2025

2007: 272008: 322009: 232010: 232011: 222012: 262013: 222014: 172015: 252016: 152017: 202018: 222019: 262020: 262021: 172022: 182023: 162024: 172025: 72026 (partial year): 10
2007high 32 (2008) · low 7 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWQ

64in 2025

2007: 101 days median2008: 70 days median2009: 90 days median2010: 104 days median2011: 95 days median2012: 90 days median2013: 88 days median2014: 124 days median2015: 102 days median2016: 121 days median2017: 67 days median2018: 95 days median2019: 81 days median2020: 55 days median2021: 59 days median2022: 85 days median2023: 59 days median2024: 64 days median2025: 64 days median2026 (partial year): 76 days median
2007high 124 (2014) · low 55 (2020)2026

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

Recalls per year · KWQ

1in 2018

2007: 22008: 332009: 352010: 22011: 52012: 72013: 62015: 22016: 92017: 82018: 1
2007high 35 (2009) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · KWQ

248in 2025

2007: 2882008: 3482009: 3552010: 6912011: 4152012: 5442013: 7962014: 5462015: 5622016: 5022017: 4922018: 3412019: 2982020: 4002021: 5912022: 3922023: 3202024: 4192025: 248
2007high 796 (2013) · low 248 (2025)2025

MAUDE reports naming product code KWQ, 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
2007271012288
2008327033348
2009239035355
2010231042691
201122955415
201226907544
201322886796
2014171240546
2015251022562
2016151219502
201720678492
201822951341
201926810298
202026550400
202117590591
202218850392
202316590320
202417640419
20257640248
202610760—

What is it indicated for?

The TranS1® AxiaLIF® System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1 or 2), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The TranS1® AxiaLIF® is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 3 and 4), tumor or trauma. Its…

Read the full statement (140 words)

The TranS1® AxiaLIF® System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1 or 2), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The TranS1® AxiaLIF® is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 3 and 4), tumor or trauma. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5 - S1 in conjunction with legally marketed facet or pedicle screw systems.

The intended use of the TranS1 Trans-Sacral Spinal Access and Preparation Device is for minimally invasive access to the anterior portion of the lower spine for assisting in the treatment of degeneration of the lumbar disc, performing lumbar discectomy or for assistance in the performance of L5-Si interbody fusion.

Indications for use as stated in the FDA summary.

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
  • K100210TRANS1 Lateral Intervertebral Fusion Device, TTrans1 Incorporated · 2010
  • K092124Axialif 2L, Axialif 2-Level System, Axialif Apollo, Axialif IITrans1 Incorporated · 2010
  • K073643TRANS1 Axialif 2-Level or II SystemTrans1 Incorporated · 2008

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https://510kreport.com/device/K073514 · printed Nov 4, 2026

Cite this page

510(k) Report. “K073514: TRANS1 Axial Fixaton System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073514

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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