510(k) · Cleared
ClearedTranS1 AxiaLIF Plus System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Trans1 · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Nov 20, 2019 as substantially equivalent to K102334 (Trans1 Incorporated, 2011) after a 51-day review. Its family tree reaches back 5 generations to 2000.
- Decided
- Nov 20, 2019
- Review
- 51 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K002371 (2000). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK002371 K-Centrum Anterior Spinal Fixation SystemSpineology, Inc. · 2000
- 4 generations backK040426 TRANS1 Axial Fixation SystemTrans1, Inc. · 2004
- 3 generations backK050965 TRANS1 Axialif SystemTrans1 Incorporated · 2005
- 2 generations backK073514 TRANS1 Axial Fixaton SystemTrans1 Incorporated · 2008
- 1 generation backK102334 TRANS1 Axialif PlusTrans1 Incorporated · 2011
- This deviceK192792 TranS1 AxiaLIF Plus SystemTrans1 · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K002371 | K-Centrum Anterior Spinal Fixation System | Spineology, Inc. | 2000 | — |
| −4 | K040426 | TRANS1 Axial Fixation System | Trans1, Inc. | 2004 | — |
| −3 | K050965 | TRANS1 Axialif System | Trans1 Incorporated | 2005 | — |
| −2 | K073514 | TRANS1 Axial Fixaton System | Trans1 Incorporated | 2008 | — |
| −1 | K102334 | TRANS1 Axialif Plus | Trans1 Incorporated | 2011 | — |
| 0 (this device) | K192792 | TranS1 AxiaLIF Plus System | Trans1 | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 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 |
|---|---|---|---|
| * | K102334 | TRANS1 Axialif PlusSummary page 4…t Code and Classification: Regulation Number: 21 CFR 888.3060 KWQ, Class Il, Spinal Intervertebral Body Fixation Orthosis Primary Predicate: TranS1 AxiaLIF Plus System (K102334) Device Description: The TranS1 AxiaLIF Plus system is a multi-component system including titanium alloy implantable devices an… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 19 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- None of the 7 ancestors has a recall.
- 1 other device also cites its predicate K102334.
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. 2019, 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 Plus System is intended to provide anterior stabilization of the L5-S1 or L4-S1 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 1 or 2 if single-level; Grade 1 if two-level), or degenerative disc disease as defined as back pain of discogenic origin with degeneration of the…
Read the full statement (111 words)
TranS1 AxiaLIF Plus System is intended to provide anterior stabilization of the L5-S1 or L4-S1 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 1 or 2 if single-level; Grade 1 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 L4-S1 in conjunction with legally marketed facet screw or pedicle screw systems at the same levels that are treated with AxiaLIF.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K192792 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192792: TranS1 AxiaLIF Plus System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192792
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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