510(k) · Cleared
ClearedPlus Pivot Link Universal 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 Jan 27, 2004 after an 82-day review. The FDA summary names its predicate without a number. 6 later devices descend from it.
- Decided
- Jan 27, 2004
- Review
- 82 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 1 citing it directly.
- This deviceK033508 Plus Pivot Link Universal SystemSpine Vision, Inc. · 2004
- Descendant · cites it directly · 5 of its ownK112607 Spinevision Lumis (TM) Cannulated Polyaxial Pedicle Screw Fixation…Spinevision S.A. · 2012
- Descendant · 2 generations on · 4 of its ownK130302 Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation…Spinevision S.A. · 2013
- Descendant · 2 generations on · 3 of its ownK133575 Spinevision Lumis Cannulated Pedicle Screw Fixation System…Spinevision S.A. · 2014
- Descendant · 2 generations on · 2 of its ownK160124 LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle…Spinevision S.A. · 2016
- Descendant · 3 generations on · 1 of its ownK200267 LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd. · 2020
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K112607Spinevision Lumis (TM) Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A. · 2012 · cites it directly5descendants
- K130302Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Spinevision S.A. · 2013 · 2 generations on4descendants
- K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A. · 2014 · 2 generations on3descendants
- K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A. · 2016 · 2 generations on2descendants
- K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd. · 2020 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033508 | Plus Pivot Link Universal System | Spine Vision, Inc. | 2004 | — |
| +1 | K112607 | Spinevision Lumis (TM) Cannulated Polyaxial Pedicle Screw Fixation System… | Spinevision S.A. | 2012 | — |
| +2 | K130302 | Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation System… | Spinevision S.A. | 2013 | — |
| +2 | K133575 | Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision… | Spinevision S.A. | 2014 | — |
| +2 | K160124 | LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw… | Spinevision S.A. | 2016 | — |
| +3 | K200267 | LOSPA® IS™ Spinal Fixation System | Corentec Co., Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | PLUS Pivot Link Spinal System Named without a submission number | |
| * | — | MOSS Miami Spinal System Named without a submission number | |
| * | — | Universal Spine System Named without a submission number |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112607 | Spinevision Lumis (TM) Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision… | 2012 | 5 |
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, K112607 (Spinevision S.A., 2012) has gone furthest, with 5 descendants of its own.
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?
When used for anterior screw fixation or as a posterior, non-pedicle system of the noncervical spine, the PLUS TM Pivot Link Universal System is indicated for: * degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) * spondylolisthesis * fracture * spinal stenosis * deformities (i.e. scoliosis, kyphosis, lordosis) * tumors * failed previous fusion (pseudoarthrosis) The PLUS Pivot Link…
Read the full statement (206 words)
When used for anterior screw fixation or as a posterior, non-pedicle system of the noncervical spine, the PLUS TM Pivot Link Universal System is indicated for:
* degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
* spondylolisthesis
* fracture
* spinal stenosis
* deformities (i.e. scoliosis, kyphosis, lordosis)
* tumors
* failed previous fusion (pseudoarthrosis)
The PLUS Pivot Link Universal System is also 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 PLUS Pivot Link Universal 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/K033508 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033508: Plus Pivot Link Universal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033508
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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