510(k) · Cleared

Cleared

TRANS1 Axial Fixation System

K040426510(k) TraditionalCleared Dec 17, 2004302-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, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body

Cleared on Dec 17, 2004 as substantially equivalent to K002371 (Spineology, Inc., 2000) after a 302-day review. Its family tree reaches back 1 generation to 2000. 64 later devices descend from it.

Decided: Dec 17, 2004
Review: 302 days
Class: Class II
Product code: KWQ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K002371 (2000). 64 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK002371 K-Centrum Anterior Spinal Fixation SystemSpineology, Inc. · 2000
This deviceK040426 TRANS1 Axial Fixation SystemTrans1, Inc. · 2004
Descendant · cites it directly · 63 of its ownK050965 TRANS1 Axialif SystemTrans1 Incorporated · 2005
Descendant · cites it directly · 62 of its ownK073514 TRANS1 Axial Fixaton SystemTrans1 Incorporated · 2008
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

Showing 5 of 64 descendants. See all descendants

Descendants cleared per year

2005high 15 (2025) · low 0 (2006)2026

Most influential descendants

Showing 5 of 64 · See all

K050965TRANS1 Axialif SystemTrans1 Incorporated · 2005 · cites it directly63descendants
K073514TRANS1 Axial Fixaton SystemTrans1 Incorporated · 2008 · 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

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K002371	K-Centrum Anterior Spinal Fixation System	Spineology, Inc.	2000	—
0 (this device)	K040426	TRANS1 Axial Fixation System	Trans1, Inc.	2004	—
+1	K050965	TRANS1 Axialif System	Trans1 Incorporated	2005	—
+1	K073514	TRANS1 Axial Fixaton System	Trans1 Incorporated	2008	—
+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	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2008	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

FIG. 1 — Lineage of K040426, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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	Applicant	Decided	Recalls
*	K002371	K-Centrum Anterior Spinal Fixation System Summary page 1 …lent to: Manufacturer Device 510 (k) Cleared Spineology Group, LLC K-Centrum Anterior Spinal Fixation K002371 09/15/2000 System 5. Device Description The TranSl Axial Fixation System is a multi…	Spineology, Inc.	2000	—

Also cleared against K002371: 2 other devices →

What descends from it? (64)

See all 64

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

Number	Device	Applicant	Decided	Descendants
K050965	TRANS1 Axialif System	Trans1 Incorporated	2005	63
K073514	TRANS1 Axial Fixaton System	Trans1 Incorporated	2008	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?

Its one ancestor has no recall.
Of its descendants, K050965 (Trans1 Incorporated, 2005) has gone furthest, with 63 descendants of its own.
2 other devices also cite its predicate K002371.

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.

FDA decisions per year · KWQ

7in 2025

2007high 32 (2008) · low 7 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWQ

64in 2025

2007high 124 (2014) · low 55 (2020)2026

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

Recalls per year · KWQ

1in 2018

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

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

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?

The TranS1 TM Axial Fixation 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 TranS1TM Axial Fixation System 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 pedicle screw systems.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040426 · printed Nov 4, 2026

Cite this page

510(k) Report. “K040426: TRANS1 Axial Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040426

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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