510(k) · Cleared
ClearedUni-Thread Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spine Vision, Inc. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Nov 7, 2005 as substantially equivalent to K013301 (Spine Vision, Inc., 2002) and 1 other predicate after a 67-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Nov 7, 2005
- Review
- 67 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K013301 (2002). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK013301 Uni-T Spinal SystemSpine Vision, Inc. · 2002
- This deviceK052406 Uni-Thread Spinal SystemSpine Vision, Inc. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K013301 | Uni-T Spinal System | Spine Vision, Inc. | 2002 | — |
| 0 (this device) | K052406 | Uni-Thread Spinal System | Spine Vision, Inc. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 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 MNI? 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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K013301 | Uni-T Spinal SystemSummary page 1…888.3070 Pedicle Screw Spinal System DEVICE PRODUCT CODE: Product code: 87 MNH, MN[ SUBSTANTIALLY EQUIVALENT DEVICES: K013301 and K021 510, Uni-Thread Spinal System, SpineVision, Inc. DEVICE DESCRIPTION AND INTENDED)… | 2002 |
| * | K021510 | Uni-T Uni-Thread Spinal SystemSummary page 1…888.3070 Pedicle Screw Spinal System DEVICE PRODUCT CODE: Product code: 87 MNH, MN[ SUBSTANTIALLY EQUIVALENT DEVICES: K013301 and K021 510, Uni-Thread Spinal System, SpineVision, Inc. DEVICE DESCRIPTION AND INTENDED) USE: The Uni-… | 2002 |
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?
- None of the 2 ancestors has a recall.
- 2 other devices also cite its predicate K013301.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 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.
https://510kreport.com/device/K052406 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052406: 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/K052406
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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