510(k) · Cleared
ClearedSpinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision U.L.I.S. Polyaxial Pedicle Screw Fixat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spinevision S.A. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Jul 30, 2013 as substantially equivalent to K112607 (Spinevision S.A., 2012) after a 173-day review. Its family tree reaches back 11 generations to 1999. 4 later devices descend from it.
- Decided
- Jul 30, 2013
- Review
- 173 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K990745 (1999). 41 ancestors in all, the oldest K962628 (1997). 4 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 7 generations between
- 3 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 2 generations backK111479 Revere CrosstopGlobus Medical, Inc. · 2011
- 1 generation backK112607 Spinevision Lumis (TM) Cannulated Polyaxial Pedicle Screw Fixation…Spinevision S.A. · 2012
- This deviceK130302 Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation…Spinevision S.A. · 2013
- Descendant · cites it directly · 3 of its ownK133575 Spinevision Lumis Cannulated Pedicle Screw Fixation System…Spinevision S.A. · 2014
- Descendant · cites it directly · 2 of its ownK160124 LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle…Spinevision S.A. · 2016
- Descendant · 2 generations on · 1 of its ownK200267 LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd. · 2020
- Descendant · 3 generations on · 0 of its ownK240180 Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd. · 2024
Show all 11 generations
- Root · 11 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 10 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 9 generations backK040442 Protex Stabilization SystemGlobus Medical, Inc. · 2004
- 8 generations backK052069 Protex Stabilization System with Additional ComponentesGlobus Medical, Inc. · 2005
- 7 generations backK061202 Revere Stabilization SystemGlobus Medical, Inc. · 2006
- 6 generations backK081195 Revere Uniplanar ScrewsGlobus Medical, Inc. · 2008
- 5 generations backK091782 Revere 6.35 Stabilization SystemGlobus Medical, Inc. · 2009
- 4 generations backK093294 Revere Stabilization SystemGlobus Medical, Inc. · 2010
- 3 generations backK100788 Cocr RodsGlobus Medical, Inc. · 2010
- 2 generations backK111479 Revere CrosstopGlobus Medical, Inc. · 2011
- 1 generation backK112607 Spinevision Lumis (TM) Cannulated Polyaxial Pedicle Screw Fixation…Spinevision S.A. · 2012
- This deviceK130302 Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation…Spinevision S.A. · 2013
Most influential descendants
Showing 4 of 4 · See all- K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…Spinevision S.A. · 2014 · cites it directly3descendants
- K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A. · 2016 · cites it directly2descendants
- K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd. · 2020 · 2 generations on1descendant
- K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −10 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −9 | K040442 | Protex Stabilization System | Globus Medical, Inc. | 2004 | — |
| −8 | K052069 | Protex Stabilization System with Additional Componentes | Globus Medical, Inc. | 2005 | — |
| −7 | K061202 | Revere Stabilization System | Globus Medical, Inc. | 2006 | — |
| −6 | K081195 | Revere Uniplanar Screws | Globus Medical, Inc. | 2008 | — |
| −5 | K091782 | Revere 6.35 Stabilization System | Globus Medical, Inc. | 2009 | — |
| −4 | K093294 | Revere Stabilization System | Globus Medical, Inc. | 2010 | — |
| −3 | K100788 | Cocr Rods | Globus Medical, Inc. | 2010 | — |
| −2 | K111479 | Revere Crosstop | Globus Medical, Inc. | 2011 | — |
| −1 | K112607 | Spinevision Lumis (TM) Cannulated Polyaxial Pedicle Screw Fixation System… | Spinevision S.A. | 2012 | — |
| 0 (this device) | K130302 | Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation System… | Spinevision S.A. | 2013 | — |
| +1 | K133575 | Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision… | Spinevision S.A. | 2014 | — |
| +1 | K160124 | LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw… | Spinevision S.A. | 2016 | — |
| +2 | K200267 | LOSPA® IS™ Spinal Fixation System | Corentec Co., Ltd. | 2020 | — |
| +3 | K240180 | Orthopeasia Spinal Fixation System | Orthopeasia Co., Ltd. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 5 | 0 |
| 2004 | 8 | 0 |
| 2005 | 4 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (1)
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 |
|---|---|---|---|
| * | K112607 | Spinevision Lumis (TM) Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…Summary page 1…dlicle Screw Legally marketed Fixation System and SpineVision U.L.I.S.TM Polyaxial Pedicle predicate device Screw Fixation System - K112607 manufactured by SPINEVISION S.A. SPECIAL 510k Modification to K112607… | 2012 |
What descends from it? (4)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 4 of the 41 ancestors have a recall of any class.
- Of its descendants, K133575 (Spinevision S.A., 2014) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K112607.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
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 non-cervical spine, the U.L.I.S. TM and LUMIS' M systems are indicated for: * degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies) * spondylolisthesis * fracture * spinal stenosis * tumors * failed previous fusion (pseudoarthrosis) The U.L.I.S. m and LU MIS TM systems are pedicle screw systems…
Read the full statement (196 words)
When used for anterior screw fixation or as a posterior, non-pedicle system of the non-cervical spine, the U.L.I.S. TM and LUMIS' M systems are indicated for:
* degenerative disc disease (discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)
* spondylolisthesis
* fracture
* spinal stenosis
* tumors
* failed previous fusion (pseudoarthrosis)
The U.L.I.S. m and LU MIS TM systems are pedicle screw systems indicated for skeletally mature patients who:
* have severe spondylolisthesis (Grades 3 and 4) at the LS-S1 vertebra;
* receive fusions using autogenous bone graft only;
* have the device fixed or attached to the lumbar and sacral spine (L-3 to sacrum); and
* have the device removed after the development of a solid fusion.
In addition, the U.L. I.S. Th' and LUMIS' M systems are pedicle screw systems 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 (TiC-Si):
* degenerative spondylolisthesis with objective evidence of neurologic impairment
* fracture
* spinal tumor
* failed previous fusion (pseudoarthrosis)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130302 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130302: Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision U.L.I.S. Polyaxial Pedicle Screw Fixat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130302
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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