510(k) Report

510(k) · Cleared

Cleared

Uni-Thread Spinal System

K042640510(k) TraditionalCleared Nov 23, 200457-day reviewClass II21 CFR 888.3070

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

Spine Vision, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Nov 23, 2004 as substantially equivalent to K013301 (Spine Vision, Inc., 2002) and 2 other predicates after a 57-day review. Its family tree reaches back 3 generations to 2002.

Decided
Nov 23, 2004
Review
57 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
3

Its longest line of descent runs back 3 generations to K021564 (2002). 5 ancestors in all, the oldest K013301 (2002). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 2 other ancestorsK021564 · Incompass Spinal Fixation System · Spinal Concepts, Inc. · 2002 · recalledK023644 · Modification to Incompass Spinal Fixation System · Spinal Concepts, Inc. · 2002 · recalledK030625 · Spinal Concepts Inc. Pathfinder · Spinal Concepts, Inc. · 2003 · recalled2000200220042006
Other ancestors, by generation 1 generation back: 2 other ancestors K030625 · Spinal Concepts Inc. Pathfinder · Spinal Concepts, Inc. · 2003 · recalledK023644 · Modification to Incompass Spinal Fixation System · Spinal Concepts, Inc. · 2002 · recalledK021564 · Incompass Spinal Fixation System · Spinal Concepts, Inc. · 2002 · recalled0
  1. Root · 3 generations backK021564 Incompass Spinal Fixation SystemSpinal Concepts, Inc. · 2002 · Recalled
  2. 2 generations backK023644 Modification to Incompass Spinal Fixation SystemSpinal Concepts, Inc. · 2002 · Recalled
  3. 1 generation backK030625 Spinal Concepts Inc. PathfinderSpinal Concepts, Inc. · 2003 · Recalled
  4. This deviceK042640 Uni-Thread Spinal SystemSpine Vision, Inc. · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K021564Incompass Spinal Fixation SystemSpinal Concepts, Inc.20021
−2K023644Modification to Incompass Spinal Fixation SystemSpinal Concepts, Inc.20021
−1K030625Spinal Concepts Inc. PathfinderSpinal Concepts, Inc.20036
0 (this device)K042640Uni-Thread Spinal SystemSpine Vision, Inc.2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200220
FIG. 1 — Lineage of K042640, 2002–2004Source: 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 MNH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against? (3)

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
*K013301Uni-T Spinal System
Summary page 1
…Product code: 87 MNH, MNI SUBSTANTIALLY EQUIVALENT DEVICES: Uni-Thread Spinal System, SpineVision, Inc., K013301 and K021510 Pathfinder System, Spinal Concepts, Inc., K030625 DEVICE DESCRIPTION AND INTEN…
Spine Vision, Inc.2002—
*K021510Uni-T Uni-Thread Spinal System
Summary page 1
…uct code: 87 MNH, MNI SUBSTANTIALLY EQUIVALENT DEVICES: Uni-Thread Spinal System, SpineVision, Inc., K013301 and K021510 Pathfinder System, Spinal Concepts, Inc., K030625 DEVICE DESCRIPTION AND INTENDED USE: The…
Spine Vision, Inc.2002—
*K030625Spinal Concepts Inc. Pathfinder
Summary page 1
…inal System, SpineVision, Inc., K013301 and K021510 Pathfinder System, Spinal Concepts, Inc., K030625 DEVICE DESCRIPTION AND INTENDED USE: The Uni-Threaad Spinal System instrumentation consists of screws, rods, and connectors that…
Spinal Concepts, Inc.20036

Also cleared against K013301: 2 other devices →

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 2 years and passes through 2 companies; a new generation was cleared every 4 months on median.
  • 3 of the 5 ancestors have a recall of any class.
  • 2 other devices also cite its predicate K013301.

How does its category compare?

All MNH devices

MNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MNH

8in 2016

2007: 52008: 132009: 132010: 102011: 172012: 72013: 102014: 122015: 102016: 8
2007high 17 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNH

93in 2016

2007: 123 days median2008: 65 days median2009: 151 days median2010: 106 days median2011: 171 days median2012: 93 days median2013: 124 days median2014: 140 days median2015: 99 days median2016: 93 days median
2007high 171 (2011) · low 65 (2008)2026

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

Recalls per year · MNH

1in 2016

2009: 72012: 12013: 12016: 1
2007high 7 (2009) · low 0 (2007)2026

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

Adverse event reports per year · MNH

89in 2025

2007: 182008: 302009: 452010: 592011: 1072012: 4332013: 4642014: 2862015: 1522016: 2162017: 1742018: 1292019: 4032020: 4322021: 5312022: 2652023: 1212024: 3022025: 89
2007high 531 (2021) · low 18 (2007)2025

MAUDE reports naming product code MNH, 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
20075123018
20081365030
200913151745
201010106059
2011171710107
20127931433
2013101241464
2014121400286
201510990152
20168931216
20170—0174
20180—0129
20190—0403
20200—0432
20210—0531
20220—0265
20230—0121
20240—0302
20250—089
20260—0—

What is it indicated for?

The Uni-Thread Spinal System is a pedicle screw system indicated for skeletally mature patients who: * have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra; * receive fusions using autogenous bone graft only; * have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and * have the device removed after the development of a solid fusion. In addition, the Uni-Thread Spinal System is a pedicle screw system intended to…

Read the full statement (137 words)

The Uni-Thread Spinal System is a pedicle screw system indicated for skeletally mature patients who:

* have severe spondylolisthesis (Grades 3 and 4) at the L5-S1 vertebra;

* receive fusions using autogenous bone graft only;

* have the device fixed or attached to the lumbar and sacral spine (L3 to sacrum); and

* have the device removed after the development of a solid fusion.

In addition, the Uni-Thread Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine:

* Degenerative spondylolisthesis with objective evidence of neurologic impairment

* fracture

* dislocation

* scoliosis

* kyphosis

* spinal tumor

* failed previous fusion (pseudoarthrosis)

Indications for use as stated in the FDA summary.

Also cleared against K013301

2 other devices cite the same predicate.

  • K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A. · 2014
  • K052406Uni-Thread Spinal SystemSpine Vision, Inc. · 2005

More from Spine Vision, Inc.

12 FDA decisions under this applicant name. See the company

  • K052406Uni-Thread Spinal SystemSpine Vision, Inc. · 2005
  • K030526Pediguard Nerve Detector SystemSpine Vision, Inc. · 2004
  • K042930Spacevision Cage SystemSpine Vision, Inc. · 2004
  • K033508Plus Pivot Link Universal SystemSpine Vision, Inc. · 2004
  • K032398Plus Pivot Link Universal SystemSpine Vision, Inc. · 2003

Recent decisions in MNH

The MNH category page

  • K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2016
  • K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2016
  • K162143FixxSure® X-LinkInnovasis, Inc. · 2016
  • K161151Spinal fixation systemCanwell Medical Co., Ltd. · 2016
  • K162189ANAX™ 5.5 Spinal SystemU&I Corporation · 2016

https://510kreport.com/device/K042640 · printed Nov 5, 2026

Cite this page

510(k) Report. “K042640: Uni-Thread Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042640

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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