510(k) Report

510(k) · Cleared

Cleared

TRANS1 Facet Screws

K051856510(k) TraditionalCleared Sep 26, 200580-day reviewClass U

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

Trans1 Incorporated · MRW System, Facet Screw Spinal Device

Cleared on Sep 26, 2005 as substantially equivalent to K003928 (Medtronic Sofamor Danek, Inc., 2001) and 1 other predicate after an 80-day review. Its family tree reaches back 1 generation to 1997. 45 later devices descend from it.

Decided
Sep 26, 2005
Review
80 days
Class
Class U
Product code
MRW
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K953076 (1997). 2 ancestors in all. 45 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2001: 1 other ancestor2008: 2 descendants cleared2011: 3 descendants cleared2016: 2 descendants cleared2013: 4 descendants cleared2009: 3 descendants cleared2015: 2 descendants cleared2010: 3 descendants cleared2017: 1 descendant cleared2012: 1 descendant cleared2026: 4 descendants cleared2022: 2 descendants cleared2019: 2 descendants cleared2024: 7 descendants cleared2023: 3 descendants cleared2025: 6 descendants clearedK953076 · Townley Facet/Pedicular Screw Plating System · Sofamor Danek USA,Inc. · 19971995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 11 descendants3 generations forward: 10 descendants4 generations forward: 12 descendants5 generations forward: 8 descendants6 generations forward: 2 descendants7 generations forward: 1 descendant K953076 · Townley Facet/Pedicular Screw Plating System · Sofamor Danek USA,Inc. · 19970+5
  1. Root · 1 generation backK953076 Townley Facet/Pedicular Screw Plating SystemSofamor Danek USA,Inc. · 1997
  2. This deviceK051856 TRANS1 Facet ScrewsTrans1 Incorporated · 2005
  3. Descendant · cites it directly · 44 of its ownK073515 TRANS1 Facet ScrewTrans1 Incorporated · 2008
  4. Descendant · 2 generations on · 29 of its ownK092568 Spartan S3 Facet SystemAmendia, Inc. · 2009
  5. Descendant · 3 generations on · 26 of its ownK120340 Venus Facet Screw SystemApollo Spine, Inc. · 2012
  6. Descendant · 3 generations on · 18 of its ownK163374 ALLY™ Facet ScrewsProvidence Medical Technology, Inc. · 2017
  7. Descendant · 2 generations on · 11 of its ownK132126 Spectrum Spine Fenestrated Facet Screw SystemSpectrum Spine, LLC · 2013

Showing 5 of 45 descendants. See all descendants

Descendants cleared per year

2008: 22009: 32010: 32011: 32012: 12013: 42015: 22016: 22017: 12019: 22022: 22023: 32024: 72025: 62026: 4
2008high 7 (2024) · low 0 (2014)2026

Most influential descendants

Showing 5 of 45 · See all
  • K073515TRANS1 Facet ScrewTrans1 Incorporated · 2008 · cites it directly44descendants
  • K092568Spartan S3 Facet SystemAmendia, Inc. · 2009 · 2 generations on29descendants
  • K120340Venus Facet Screw SystemApollo Spine, Inc. · 2012 · 3 generations on26descendants
  • K163374ALLY™ Facet ScrewsProvidence Medical Technology, Inc. · 2017 · 3 generations on18descendants
  • K132126Spectrum Spine Fenestrated Facet Screw SystemSpectrum Spine, LLC · 2013 · 2 generations on11descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K953076Townley Facet/Pedicular Screw Plating SystemSofamor Danek USA,Inc.1997—
0 (this device)K051856TRANS1 Facet ScrewsTrans1 Incorporated2005—
+1K073515TRANS1 Facet ScrewTrans1 Incorporated2008—
+2K092568Spartan S3 Facet SystemAmendia, Inc.2009—
+3K120340Venus Facet Screw SystemApollo Spine, Inc.2012—
+3K163374ALLY™ Facet ScrewsProvidence Medical Technology, Inc.2017—
+2K132126Spectrum Spine Fenestrated Facet Screw SystemSpectrum Spine, LLC2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200820
200930
201030
201130
201210
201340
201520
201620
201710
201920
202220
202330
202470
202560
202640
FIG. 1 — Lineage of K051856, 1997–2026Source: 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 MRW? 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 MRW device

  1. #1 K230840 PMT Facet Fixation System, Lumbar (PMT FFS-LX)score 26.0 · 6 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K003928Townley Transfacetpedicular Screw Fixation System
Summary page 2
…was provided to demonstrate that the TranSI® Facet Screws are substantially equivalent to the Medtronic Sofamor Danek Townley Transfacetpedicular Screw Fixation System (K003928) and the Sofamnore Danek Transfacetpedicular Screw Fixation System (K953076). The TranSl devices are substantially equivalent to…
Medtronic Sofamor Danek, Inc.2001—
*K953076Townley Facet/Pedicular Screw Plating System
Summary page 2
…equivalent to the Medtronic Sofamor Danek Townley Transfacetpedicular Screw Fixation System (K003928) and the Sofamnore Danek Transfacetpedicular Screw Fixation System (K953076). The TranSl devices are substantially equivalent to the predicate devices in intended use, level of attachment, materials, label…
Sofamor Danek USA,Inc.1997—

Also cleared against K003928: 4 other devices →

What descends from it? (45)

See all 45

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

NumberDeviceApplicantDecidedDescendants
K073515TRANS1 Facet ScrewTrans1 Incorporated200844

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?

  • None of the 2 ancestors has a recall.
  • Of its descendants, K073515 (Trans1 Incorporated, 2008) has gone furthest, with 44 descendants of its own.
  • 4 other devices also cite its predicate K003928.

How does its category compare?

All MRW devices

MRW System, Facet Screw Spinal Device: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MRW

7in 2025

2008: 32009: 62010: 62011: 32012: 42013: 72015: 22016: 22017: 12018: 22019: 32022: 32023: 32024: 72025: 72026 (partial year): 5
2007high 7 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MRW

97in 2025

2008: 88 days median2009: 89 days median2010: 108 days median2011: 122 days median2012: 119 days median2013: 110 days median2019: 90 days median2022: 252 days median2023: 190 days median2024: 50 days median2025: 97 days median2026 (partial year): 169 days median
2007high 252 (2022) · low 50 (2024)2026

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

Recalls per year · MRW

3in 2011

2011: 3
2007high 3 (2011) · low 0 (2007)2026

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

Adverse event reports per year · MRW

3in 2025

2007: 12009: 22010: 72011: 622012: 62013: 42014: 12015: 22016: 12017: 42018: 42021: 12023: 12024: 22025: 3
2007high 62 (2011) · low 0 (2008)2025

MAUDE reports naming product code MRW, 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
20070—01
200838800
200968902
2010610807
20113122362
2012411906
2013711004
20140—01
20152—02
20162—01
20171—04
20182—04
201939000
20200—00
20210—01
2022325200
2023319001
202475002
202579703
202651690—

What is it indicated for?

The TranSI® Facet Screws are to be used in conjunction with the TranSI® AxiaLIF M System which includes the TranSI® 3D Axial RodTM, in order to create an anterior/posterior fixation construct as an aid to fusion. The AxiaLIFTM 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…

Read the full statement (191 words)

The TranSI® Facet Screws are to be used in conjunction with the TranSI® AxiaLIF M System which includes the TranSI® 3D Axial RodTM, in order to create an anterior/posterior fixation construct as an aid to fusion.

The AxiaLIFTM 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 AxiaLIFTM 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 facet and pedicle screw systems.

The facet screws may be implanted using one of two techniques: transfacetpedicular or translaminar. The screws are inserted bilaterally through the superior side of the facet, across the facet joint and into the pedicle. Alternatively, the facet screws may be cross inserted from the base of the spinous process into the opposite lamina and across the facet joint into the base of the lower vertebral transverse process.

Indications for use as stated in the FDA summary.

Also cleared against K003928

4 other devices cite the same predicate.

  • K180729FaSet Fixation SystemHuvexel Co., Ltd. · 2018
  • K131417Facet FixxNexxt Spine, LLC · 2013
  • K073515TRANS1 Facet ScrewTrans1 Incorporated · 2008
  • K012773Discovery Facet Screw Fixation SystemDepuyacromed · 2001

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

Recent decisions in MRW

The MRW category page

  • K262618Arthrex Spine Compression FT ScrewArthrex, Inc. · 2026
  • K261209Ion-LSurGenTec, LLC · 2026
  • K253676CORUS™ Posterior Cervical Stabilization System 3D (CORUS™ PCSS 3D)Providence Medical Technology, Inc. · 2026
  • K253432DiversiVy™ Facet Screw SystemVy Spine, LLC · 2026
  • K251714Ion-CSurGenTec, LLC · 2026

https://510kreport.com/device/K051856 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051856: TRANS1 Facet Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051856

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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