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 Sep 23, 2002 after a 72-day review. The FDA summary names its predicate without a number. 180 later devices descend from it.
- Decided
- Sep 23, 2002
- Review
- 72 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 0
180 later devices descend from it, 1 citing it directly.
- This deviceK022271 Plus Pivot Link Universal SystemSpine Vision, Inc. · 2002
- Descendant · cites it directly · 179 of its ownK031455 Conklusion Pedicle Screw SystemSignus Medical, LLC · 2003
- Descendant · 2 generations on · 178 of its ownK070933 Lowtop Pedicle Screw SystemSanacor · 2007
- Descendant · 3 generations on · 177 of its ownK072187 Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology · 2007
- Descendant · 4 generations on · 174 of its ownK080518 Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology · 2008
- Descendant · 5 generations on · 136 of its ownK100297 Pass LP Spinal SystemMedicrea Technologies · 2010
Showing 5 of 180 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 180 · See all- K031455Conklusion Pedicle Screw SystemSignus Medical, LLC · 2003 · cites it directly179descendants
- K070933Lowtop Pedicle Screw SystemSanacor · 2007 · 2 generations on178descendants
- K072187Pioneer Lowtop Spinal Rod SystemPioneer Surgical Technology · 2007 · 3 generations on177descendants
- K080518Pioneer Surgical Technology Quantum Spinal SystemPioneer Surgical Technology · 2008 · 4 generations on174descendants
- K100297Pass LP Spinal SystemMedicrea Technologies · 2010 · 5 generations on136descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K022271 | Plus Pivot Link Universal System | Spine Vision, Inc. | 2002 | — |
| +1 | K031455 | Conklusion Pedicle Screw System | Signus Medical, LLC | 2003 | — |
| +2 | K070933 | Lowtop Pedicle Screw System | Sanacor | 2007 | — |
| +3 | K072187 | Pioneer Lowtop Spinal Rod System | Pioneer Surgical Technology | 2007 | — |
| +4 | K080518 | Pioneer Surgical Technology Quantum Spinal System | Pioneer Surgical Technology | 2008 | — |
| +5 | K100297 | Pass LP Spinal System | Medicrea Technologies | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 1 | 0 |
| 2013 | 7 | 0 |
| 2014 | 4 | 0 |
| 2015 | 7 | 0 |
| 2016 | 7 | 0 |
| 2017 | 10 | 0 |
| 2018 | 9 | 0 |
| 2019 | 4 | 0 |
| 2020 | 7 | 0 |
| 2021 | 8 | 0 |
| 2022 | 14 | 0 |
| 2023 | 17 | 0 |
| 2024 | 19 | 0 |
| 2025 | 24 | 0 |
| 2026 | 24 | 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 |
|---|---|---|---|
| * | — | PLUS Pivot Link Spinal System Named without a submission number | |
| * | — | CD Horizon Spinal System Named without a submission number |
What descends from it? (180)
See all 1801 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031455 | Conklusion Pedicle Screw System | 2003 | 179 |
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, K031455 (Signus Medical, LLC, 2003) has gone furthest, with 179 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 as a posterior, non-pedicle system of the noncervical spine, the PLUSTMPivot 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 (Le. scoliosis, kyphosis, lordosis) tumors failed previous fusion (pseudoarthrosis) The PLUS Pivot Link Universal System is also a pedicle screw system…
Read the full statement (182 words)
When used as a posterior, non-pedicle system of the noncervical spine, the PLUSTMPivot 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 (Le. 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-S 1 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/K022271 · printed Nov 3, 2026
Cite this page
510(k) Report. “K022271: 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/K022271
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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