510(k) · Cleared
ClearedTRANS1 Axialif 2-Level or II System
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 Apr 28, 2008 after a 124-day review. The FDA summary names its predicate without a number. 63 later devices descend from it.
- Decided
- Apr 28, 2008
- Review
- 124 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
63 later devices descend from it, 1 citing it directly.
- This deviceK073643 TRANS1 Axialif 2-Level or II SystemTrans1 Incorporated · 2008
- Descendant · cites it directly · 62 of its ownK092124 Axialif 2L, Axialif 2-Level System, Axialif Apollo, Axialif IITrans1 Incorporated · 2010
- Descendant · 2 generations on · 61 of its ownK102334 TRANS1 Axialif PlusTrans1 Incorporated · 2011
- Descendant · 3 generations on · 59 of its ownK203742 IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021
- Descendant · 4 generations on · 36 of its ownK220782 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine, Inc. · 2022
- Descendant · 5 generations on · 28 of its ownK222028 IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody…Alphatec Spine · 2022
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 63 · See all- K092124Axialif 2L, Axialif 2-Level System, Axialif Apollo, Axialif IITrans1 Incorporated · 2010 · cites it directly62descendants
- K102334TRANS1 Axialif PlusTrans1 Incorporated · 2011 · 2 generations on61descendants
- K203742IdentiTi ALIF Standalone Interbody SystemAlphatec Spine, Inc. · 2021 · 3 generations on59descendants
- K220782IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine, Inc. · 2022 · 4 generations on36descendants
- K222028IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System, Transcend™…Alphatec Spine · 2022 · 5 generations on28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K073643 | TRANS1 Axialif 2-Level or II System | Trans1 Incorporated | 2008 | — |
| +1 | K092124 | Axialif 2L, Axialif 2-Level System, Axialif Apollo, Axialif II | Trans1 Incorporated | 2010 | — |
| +2 | K102334 | TRANS1 Axialif Plus | Trans1 Incorporated | 2011 | — |
| +3 | K203742 | IdentiTi ALIF Standalone Interbody System | Alphatec Spine, Inc. | 2021 | — |
| +4 | K220782 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine, Inc. | 2022 | — |
| +5 | K222028 | IdentiTi™ Porous Ti Interbody System, IdentiTi™ NanoTec™ Interbody System… | Alphatec Spine | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | — | TranS1® AxiaLIF® System Named without a submission number |
What descends from it? (63)
See all 631 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092124 | Axialif 2L, Axialif 2-Level System, Axialif Apollo, Axialif II | 2010 | 62 |
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?
- Of its descendants, K092124 (Trans1 Incorporated, 2010) has gone furthest, with 62 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. 2008, 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?
TranS1® AxiaLIF® 2-LEVEL System is intended to provide anterior stabilization of the L4-S1 spinal segments as an adjunct to spinal fusion. The AxiaLIF® 2-LEVEL System is also intended 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 L4-S1 interbody fusion. The AxiaLIF® 2-LEVEL System is indicated…
Read the full statement (181 words)
TranS1® AxiaLIF® 2-LEVEL System is intended to provide anterior stabilization of the L4-S1 spinal segments as an adjunct to spinal fusion. The AxiaLIF® 2-LEVEL System is also intended 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 L4-S1 interbody fusion.
The AxiaLIF® 2-LEVEL System is indicated for patients requiring fusion to treat pseudoarthrosis, unsuccessful previous fusion, spinal stenosis, spondylolisthesis (Grade 1), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The AxiaLIF® 2-LEVEL System is not intended to treat severe scoliosis, severe spondylolisthesis (Grades 2, 3 and 4), tumor, or trauma. The device is not meant to be used in patients with vertebral compression fractures or any other condition where the mechanical integrity of the vertebral body is compromised. Its usage is limited to anterior supplemental fixation of the lumbar spine at L4-S1 in conjunction with legally marketed facet or pedicle screw systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073643 · printed Nov 5, 2026
Cite this page
510(k) Report. “K073643: TRANS1 Axialif 2-Level or II System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K073643
Report an extraction error
Are you the manufacturer?
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