510(k) Report

510(k) · Cleared

Cleared

TRANS1 Trans-Sacral Spinal Access and Preparation Kit

K032891510(k) TraditionalCleared Jan 15, 2004120-day reviewClass II21 CFR 888.1100

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

Trans1, Inc. · HRX Arthroscope

Cleared on Jan 15, 2004 after a 120-day review. The FDA summary names its predicate without a number. 13 later devices descend from it.

Decided
Jan 15, 2004
Review
120 days
Class
Class II
Product code
HRX
Recalls
None
Predicates
0

13 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2012: 1 descendant cleared2009: 1 descendant cleared2014: 2 descendants cleared2020: 2 descendants cleared2018: 1 descendant cleared2024: 1 descendant cleared2023: 1 descendant cleared2021: 1 descendant cleared2022: 1 descendant cleared2025: 1 descendant cleared200020052010201520202025
  1. This deviceK032891 TRANS1 Trans-Sacral Spinal Access and Preparation KitTrans1, Inc. · 2004
  2. Descendant · cites it directly · 10 of its ownK070293 Benvenue VCF Osteo Coil SystemBenvenue Medical, Inc. · 2007
  3. Descendant · 2 generations on · 9 of its ownK132817 Kiva VCF Treatment SystemBenvenue Medical, Inc. · 2014
  4. Descendant · 3 generations on · 4 of its ownK181262 SpineJack Expansion KitVexim SA · 2018
  5. Descendant · 4 generations on · 3 of its ownK202393 SpineJack Expansion KitStryker Corporation · 2020
  6. Descendant · 5 generations on · 2 of its ownK211238 SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex…Stryker Instruments · 2021

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2007: 12009: 12012: 12014: 22018: 12020: 22021: 12022: 12023: 12024: 12025: 1
2007high 2 (2014) · low 0 (2008)2026

Most influential descendants

Showing 5 of 13 · See all
  • K070293Benvenue VCF Osteo Coil SystemBenvenue Medical, Inc. · 2007 · cites it directly10descendants
  • K132817Kiva VCF Treatment SystemBenvenue Medical, Inc. · 2014 · 2 generations on9descendants
  • K181262SpineJack Expansion KitVexim SA · 2018 · 3 generations on4descendants
  • K202393SpineJack Expansion KitStryker Corporation · 2020 · 4 generations on3descendants
  • K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone…Stryker Instruments · 2021 · 5 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K032891TRANS1 Trans-Sacral Spinal Access and Preparation KitTrans1, Inc.2004—
+1K070293Benvenue VCF Osteo Coil SystemBenvenue Medical, Inc.2007—
+2K132817Kiva VCF Treatment SystemBenvenue Medical, Inc.2014—
+3K181262SpineJack Expansion KitVexim SA2018—
+4K202393SpineJack Expansion KitStryker Corporation2020—
+5K211238SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV…Stryker Instruments2021—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200910
201210
201420
201810
202020
202110
202210
202310
202410
202510
FIG. 1 — Lineage of K032891, 2004–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 HRX? 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 HRX device

  1. #1 K260203 Fule Vertebroplasty Balloon Catheterscore 14.9 · 11 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? (9)

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
*—AxiaMed, Inc., Trans-Sacral Spinal Access Device
Named without a submission number
—
*—Surgical Dynamics, Inc., 30K Working Channel Scope and instrument kit
Named without a submission number
—
*—Argus Medical Company Laparoscopic Discectomy Instrument System
Named without a submission number
—
*—Surgical Dynamics, Inc., Nucleotome Tissue Aspirator/Cutter
Named without a submission number
—
*—Surgical Dynamics, Inc., Nucleotome II Tissue Aspirator/cutter
Named without a submission number
—
*—Sofamor Danek Mfg., Inc., Danek Tissue Cutting and Removal System
Named without a submission number
—
*—United States Surgical, Auto Suture Spinal Elevator
Named without a submission number
—
*—Harrington Spinal Elevator
Named without a submission number
—
*—Karlin Technology, Inc., Cobb Spinal Elevator
Named without a submission number
—

What descends from it? (13)

See all 13

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

NumberDeviceApplicantDecidedDescendants
K070293Benvenue VCF Osteo Coil SystemBenvenue Medical, Inc.200710
K113352Transcorp Spinal Access SystemTranscorp, Inc.20120
K081240Tiger Discectomy DeviceSpinal Devices, LLC20090

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, K070293 (Benvenue Medical, Inc., 2007) has gone furthest, with 10 descendants of its own.

How does its category compare?

All HRX devices

HRX Arthroscope: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HRX

9in 2025

2007: 72008: 92009: 112010: 92011: 32012: 112013: 122014: 92015: 42016: 82017: 42018: 122019: 122020: 72021: 72022: 32023: 42024: 62025: 92026 (partial year): 7
2007high 12 (2013) · low 3 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · HRX

107in 2025

2007: 89 days median2008: 115 days median2009: 139 days median2010: 114 days median2011: 84 days median2012: 102 days median2013: 90 days median2014: 140 days median2015: 132 days median2016: 89 days median2017: 97 days median2018: 101 days median2019: 45 days median2020: 141 days median2021: 57 days median2022: 89 days median2023: 249 days median2024: 110 days median2025: 107 days median2026 (partial year): 217 days median
2007high 249 (2023) · low 45 (2019)2026

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

Recalls per year · HRX

1in 2024

2007: 32008: 132009: 232010: 122011: 62013: 42015: 72018: 12021: 32024: 1
2007high 23 (2009) · low 0 (2012)2026

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

Adverse event reports per year · HRX

2,076in 2025

2007: 4212008: 4412009: 5582010: 6122011: 6312012: 7782013: 6782014: 8022015: 7632016: 4692017: 9342018: 1,5812019: 1,6762020: 1,7062021: 1,9082022: 1,4062023: 1,8522024: 2,4272025: 2,076
2007high 2,427 (2024) · low 421 (2007)2025

MAUDE reports naming product code HRX, 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
20077893421
2008911513441
20091113923558
2010911412612
20113846631
2012111020778
201312904678
201491400802
201541327763
20168890469
20174970934
20181210111,581
2019124501,676
2020714101,706
202175731,908
202238901,406
2023424901,852
2024611012,427
2025910702,076
202672170—

What is it indicated for?

The intended use of the TranS 1 Trans-Sacral Spinal Access and Preparation Device is 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 L5-S1 interbody fusion.

Indications for use as stated in the FDA summary.

More from Trans1, Inc.

3 FDA decisions under this applicant name. See the company

  • K123997TRANS1LATERAL Interbody Fusion SystemTrans1, Inc. · 2013
  • K040426TRANS1 Axial Fixation SystemTrans1, Inc. · 2004

Recent decisions in HRX

The HRX category page

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  • K260156TruVision Single-Use 1.9mm Arthroscopy SystemNexus CMF, LLC · 2026
  • K260203Fule Vertebroplasty Balloon CatheterBeijing Fule Science & Technology Development Co., Ltd. · 2026
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  • K252790Digital ClarusScope System and Digital NeuroPEN SystemClarus Medical, LLC · 2026

https://510kreport.com/device/K032891 · printed Nov 6, 2026

Cite this page

510(k) Report. “K032891: TRANS1 Trans-Sacral Spinal Access and Preparation Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032891

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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