510(k) · Cleared
ClearedTRANS1 Axialif Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trans1 Incorporated · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Mar 14, 2011 as substantially equivalent to K073514 (Trans1 Incorporated, 2008) and 1 other predicate after a 209-day review. Its family tree reaches back 4 generations to 2000. 61 later devices descend from it.
- Decided
- Mar 14, 2011
- Review
- 209 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K002371 (2000). 6 ancestors in all. 61 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK002371 K-Centrum Anterior Spinal Fixation SystemSpineology, Inc. · 2000
- 3 generations backK040426 TRANS1 Axial Fixation SystemTrans1, Inc. · 2004
- 2 generations backK050965 TRANS1 Axialif SystemTrans1 Incorporated · 2005
- 1 generation backK073514 TRANS1 Axial Fixaton SystemTrans1 Incorporated · 2008
- This deviceK102334 TRANS1 Axialif PlusTrans1 Incorporated · 2011
- Descendant · cites it directly · 59 of its ownK203742 IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021
- Descendant · 2 generations on · 36 of its ownK220782 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine, Inc. · 2022
- Descendant · 3 generations on · 28 of its ownK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022
- Descendant · 2 generations on · 16 of its ownK214006 Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2022
- Descendant · 3 generations on · 14 of its ownK221926 Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022
Showing 5 of 61 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 61 · See all- K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021 · cites it directly59descendants
- K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc. · 2022 · 2 generations on36descendants
- K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine · 2022 · 3 generations on28descendants
- K214006Invictus® Spinal Fixation SystemAlphatec Spine, Inc. · 2022 · 2 generations on16descendants
- K221926Invictus® Bone Cement, Invictus Spinal Fixation SystemAlphatec Spine, Inc. · 2022 · 3 generations on14descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K002371 | K-Centrum Anterior Spinal Fixation System | Spineology, Inc. | 2000 | — |
| −3 | K040426 | TRANS1 Axial Fixation System | Trans1, Inc. | 2004 | — |
| −2 | K050965 | TRANS1 Axialif System | Trans1 Incorporated | 2005 | — |
| −1 | K073514 | TRANS1 Axial Fixaton System | Trans1 Incorporated | 2008 | — |
| 0 (this device) | K102334 | TRANS1 Axialif Plus | Trans1 Incorporated | 2011 | — |
| +1 | K203742 | IdentiTi ALIF Standalone Interbody System | Alphatec Spine, Inc. | 2021 | — |
| +2 | K220782 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine, Inc. | 2022 | — |
| +3 | K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine | 2022 | — |
| +2 | K214006 | Invictus® Spinal Fixation System | Alphatec Spine, Inc. | 2022 | — |
| +3 | K221926 | Invictus® Bone Cement, Invictus Spinal Fixation System | Alphatec Spine, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 6 | 0 |
| 2023 | 10 | 0 |
| 2024 | 14 | 0 |
| 2025 | 15 | 0 |
| 2026 | 14 | 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 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 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 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 |
|---|---|---|---|
| * | K073514 | TRANS1 Axial Fixaton SystemSummary page 1…cs and Substantial Equivalence: D~ocumentation was provided to demonstrate that the TranS I® AxiaLiF Plus system is substantially equivalent to the predicates AxiaL-iF (K073514) and Axial-IF 21-+ (K092124). Thle TranSl device is substantially equivalent to the predicate devices in intended use, level of a… | 2008 |
| * | K092124 | Axialif 2L, Axialif 2-Level System, Axialif Apollo, Axialif IISummary page 1…ce: D~ocumentation was provided to demonstrate that the TranS I® AxiaLiF Plus system is substantially equivalent to the predicates AxiaL-iF (K073514) and Axial-IF 21-+ (K092124). Thle TranSl device is substantially equivalent to the predicate devices in intended use, level of attachment, materials, labeli… | 2010 |
What descends from it? (61)
See all 612 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 11 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K203742 (Alphatec Spine, Inc., 2021) has gone furthest, with 59 descendants of its own.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, 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 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
What is it indicated for?
TranS I AxiaLIFO Plus System is intended to provide anterior stabilization of the L5-S I or L4-S I spinal segment (s) as an adjunct to spinal fusion. The AxiaLiF® Plus System is indicated for patients requiring fusion to treat pseudoarthrosis (unsuccessful previous fusion), spinal stenosis, spondylolisthesis (Grade I or 2 if single-level; Grade I if two-level), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of…
Read the full statement (117 words)
TranS I AxiaLIFO Plus System is intended to provide anterior stabilization of the L5-S I or L4-S I spinal segment (s) as an adjunct to spinal fusion. The AxiaLiF® Plus System is indicated for patients requiring fusion to treat pseudoarthrosis (unsuccessful previous fusion), spinal stenosis, spondylolisthesis (Grade I or 2 if single-level; Grade I if two-level), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Its usage is limited to anterior supplemental fixation of the lumbar spine at L5-S1 or L_4-SI in conjunction with use of legally marketed facet screw or pedicle screw systems at the same levels that are treated with AxiaLiF.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102334 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102334: TRANS1 Axialif Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102334
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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