510(k) Report

510(k) · Cleared

Cleared

LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System

K160124510(k) SpecialCleared Apr 4, 201675-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

Spinevision S.A. · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Apr 4, 2016 as substantially equivalent to K133575 (Spinevision S.A., 2014) and 16 other predicates after a 75-day review. Its family tree reaches back 14 generations to 1985. 2 later devices descend from it.

Decided
Apr 4, 2016
Review
75 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
17

Its longest line of descent runs back 14 generations to K853033 (1985). 207 ancestors in all, the oldest K781443 (1978). 2 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2013: 1 other ancestor2012: 2 other ancestors2010: 6 other ancestors2009: 6 other ancestors2007: 10 other ancestors2006: 9 other ancestors2005: 15 other ancestors2004: 18 other ancestors2011: 3 other ancestors2008: 9 other ancestors2003: 10 other ancestors2002: 10 other ancestors2001: 16 other ancestors2000: 15 other ancestors1998: 15 other ancestors1997: 6 other ancestors1996: 8 other ancestors1995: 8 other ancestors1994: 3 other ancestors1999: 11 other ancestors1978: 1 other ancestor1993: 3 other ancestors1992: 5 other ancestors1990: 2 other ancestors1984: 1 other ancestor2020: 1 descendant cleared2024: 1 descendant clearedK853033 · Hartshill Rect & Wires, Spinal Fixation System · A.W. Showell (Surgicraft), Ltd. · 1985K965221 · Ransford Cervical Fixation System · Surgicraft, Ltd. · 1997K982322 · Synthes Spine Occipital-Cervical Plate/Rod and Hook System · Synthes (Usa) · 1998K002733 · Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2000K013222 · Summit Occipito-Cervico- Thoracic (Oct) Spinal System · Depuyacromed · 2001K022190 · Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2002K030103 · Summit Oct Spinal System Minipolyaxial Screws · Depuyacromed · 2003K041203 · Summit Oct Spinal System · Depuy Spine, Inc. · 2004×3: 3 generations cleared close together, K062174 (2006), K063156 (2006), K063741 (2007) K080313 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2008K111571 · Viper Systems · Johnson & Johnson · 2011K133575 · Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle Screw Fixation System · Spinevision S.A. · 201419801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 14 other ancestors2 generations back: 42 other ancestors3 generations back: 37 other ancestors4 generations back: 50 other ancestors5 generations back: 42 other ancestors6 generations back: 8 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant K133575 · Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle Screw Fixation System · Spinevision S.A. · 2014K111571 · Viper Systems · Johnson & Johnson · 2011K080313 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2008K063741 · Expedium Spine System · Depuy Spine, Inc. · 2007K063156 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2006K062174 · Modification to Expedium Spine System · Depuy Spine, Inc. · 2006K041203 · Summit Oct Spinal System · Depuy Spine, Inc. · 2004K030103 · Summit Oct Spinal System Minipolyaxial Screws · Depuyacromed · 2003K022190 · Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2002K013222 · Summit Occipito-Cervico- Thoracic (Oct) Spinal System · Depuyacromed · 2001K002733 · Summit Occipito-Cervico-Thoracic (Oct) Spinal System · Depuyacromed · 2000K982322 · Synthes Spine Occipital-Cervical Plate/Rod and Hook System · Synthes (Usa) · 1998K965221 · Ransford Cervical Fixation System · Surgicraft, Ltd. · 1997K853033 · Hartshill Rect & Wires, Spinal Fixation System · A.W. Showell (Surgicraft), Ltd. · 1985−10−50
  1. Root · 14 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 10 generations between
  3. 3 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
  4. 2 generations backK111571 Viper SystemsJohnson & Johnson · 2011
  5. 1 generation backK133575 Spinevision Lumis Cannulated Pedicle Screw Fixation System…Spinevision S.A. · 2014
  6. This deviceK160124 LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle…Spinevision S.A. · 2016
  7. Descendant · cites it directly · 1 of its ownK200267 LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd. · 2020
  8. Descendant · 2 generations on · 0 of its ownK240180 Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd. · 2024
Show all 14 generations
  1. Root · 14 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 13 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
  3. 12 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
  4. 11 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
  5. 10 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
  6. 9 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
  7. 8 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
  8. 7 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
  9. 6 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
  10. 5 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
  11. 4 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
  12. 3 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
  13. 2 generations backK111571 Viper SystemsJohnson & Johnson · 2011
  14. 1 generation backK133575 Spinevision Lumis Cannulated Pedicle Screw Fixation System…Spinevision S.A. · 2014
  15. This deviceK160124 LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle…Spinevision S.A. · 2016

Most influential descendants

Showing 2 of 2 · See all
  • K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd. · 2020 · cites it directly1descendant
  • K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd. · 2024 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−14K853033Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd.1985—
−13K965221Ransford Cervical Fixation SystemSurgicraft, Ltd.1997—
−12K982322Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa)1998—
−11K002733Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2000—
−10K013222Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed2001—
−9K022190Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2002—
−8K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed2003—
−7K041203Summit Oct Spinal SystemDepuy Spine, Inc.2004—
−6K062174Modification to Expedium Spine SystemDepuy Spine, Inc.2006—
−5K063156Modification to Expedium Spine SystemDepuy Spine, Inc.2006—
−4K063741Expedium Spine SystemDepuy Spine, Inc.2007—
−3K080313Modification to Expedium Spine SystemDepuy Spine, Inc.2008—
−2K111571Viper SystemsJohnson & Johnson2011—
−1K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision…Spinevision S.A.2014—
0 (this device)K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw…Spinevision S.A.2016—
+1K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.2020—
+2K240180Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd.2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
197810
198410
199020
199250
199330
199430
199580
199680
199760
1998150
1999110
2000150
2001160
2002100
2003100
2004180
2005150
200690
2007100
200890
200960
201060
201130
201220
201310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202010
202410
FIG. 1 — Lineage of K160124, 1985–2024Source: 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 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
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What was it cleared against? (17)

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
*K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle…
Summary page 4
…on 888.3070, 888.3050 Primary Predicate: U.L.I.S.™ and LUMIS™ Pedicle Screw Fixation System (K133575) Additional predicates: Legally marketed U.L.I.S.TM and LUMISTM Pedicle Screw Fixati…
Spinevision S.A.2014—
*K130302Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…
Summary page 4
…Additional predicates: Legally marketed U.L.I.S.TM and LUMISTM Pedicle Screw Fixation System predicate devices (K130302/K112607) Xia Spinal System (K050461/K052761/K060361/K060748/ K071373/K113666)…
Spinevision S.A.2013—
*K112607Spinevision Lumis (TM) Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…
Summary page 4
…Additional predicates: Legally marketed U.L.I.S.TM and LUMISTM Pedicle Screw Fixation System predicate devices (K130302/K112607) Xia Spinal System (K050461/K052761/K060361/K060748/ K071373/K113666)…
Spinevision S.A.2012—
*K050461Xia 4.5 Spinal System
Summary page 4
…U.L.I.S.TM and LUMISTM Pedicle Screw Fixation System predicate devices (K130302/K112607) Xia Spinal System (K050461/K052761/K060361/K060748/ K071373/K113666) VIPER® System, VIPER®2 system (K061520/K111…
Stryker Spine2005—
*K052761Modification to: Xia 4.5 Spinal System
Summary page 4
…U.L.I.S.TM and LUMISTM Pedicle Screw Fixation System predicate devices (K130302/K112607) Xia Spinal System (K050461/K052761/K060361/K060748/ K071373/K113666) VIPER® System, VIPER®2 system (K061520/K111571/…
Stryker Spine2005—
*K060361Xia Spinal System, Xia 4.5 Spinal System
Summary page 4
…U.L.I.S.TM and LUMISTM Pedicle Screw Fixation System predicate devices (K130302/K112607) Xia Spinal System (K050461/K052761/K060361/K060748/ K071373/K113666) VIPER® System, VIPER®2 system (K061520/K111571/…
Stryker Spine20061
*K060748Modification to Xia 4.5 Spinal System
Summary page 4
…S.TM and LUMISTM Pedicle Screw Fixation System predicate devices (K130302/K112607) Xia Spinal System (K050461/K052761/K060361/K060748/ K071373/K113666) VIPER® System, VIPER®2 system (K061520/K111571/…
Stryker Spine2006—
*K071373Stryker Spine Xia Iii Spinal System
Summary page 4
…Fixation System predicate devices (K130302/K112607) Xia Spinal System (K050461/K052761/K060361/K060748/ K071373/K113666) VIPER® System, VIPER®2 system (K061520/K111571/ K090648/K102701)…
Stryker Spine20071
*K113666Xia 3 Spinal System
Summary page 4
…System predicate devices (K130302/K112607) Xia Spinal System (K050461/K052761/K060361/K060748/ K071373/K113666) VIPER® System, VIPER®2 system (K061520/K111571/ K090648/K102701)…
Stryker Spine2012—
*K061520Viper Spine System
Summary page 4
…07) Xia Spinal System (K050461/K052761/K060361/K060748/ K071373/K113666) VIPER® System, VIPER®2 system (K061520/K111571/ K090648/K102701) EXPEDIUM® Spine System (K041119/K062174/K090230/…
Depuy Spine, Inc.2006—
*K111571Viper Systems
Summary page 4
…Xia Spinal System (K050461/K052761/K060361/K060748/ K071373/K113666) VIPER® System, VIPER®2 system (K061520/K111571/ K090648/K102701) EXPEDIUM® Spine System (K041119/K062174/K090230/…
Johnson & Johnson2011—
*K090648Viper 2 System
Summary page 4
…stem (K050461/K052761/K060361/K060748/ K071373/K113666) VIPER® System, VIPER®2 system (K061520/K111571/ K090648/K102701) EXPEDIUM® Spine System (K041119/K062174/K090230/ K090799)…
Depuy Spine, Inc.2009—
*K102701Viper Spine System
Summary page 4
…50461/K052761/K060361/K060748/ K071373/K113666) VIPER® System, VIPER®2 system (K061520/K111571/ K090648/K102701) EXPEDIUM® Spine System (K041119/K062174/K090230/ K090799) The…
Depuy Spine, Inc.2010—
*K041119Expedium Spine System
Summary page 4
…71373/K113666) VIPER® System, VIPER®2 system (K061520/K111571/ K090648/K102701) EXPEDIUM® Spine System (K041119/K062174/K090230/ K090799) The SpineVision® Universal Lumbar Intuitive System…
Depuy Spine, Inc.2004—
*K062174Modification to Expedium Spine System
Summary page 4
…13666) VIPER® System, VIPER®2 system (K061520/K111571/ K090648/K102701) EXPEDIUM® Spine System (K041119/K062174/K090230/ K090799) The SpineVision® Universal Lumbar Intuitive System…
Depuy Spine, Inc.2006—
*K090230Expedium Spine System
Summary page 4
…VIPER® System, VIPER®2 system (K061520/K111571/ K090648/K102701) EXPEDIUM® Spine System (K041119/K062174/K090230/ K090799) The SpineVision® Universal Lumbar Intuitive System (…
Depuy Spine, Inc.2009—
*K090799Modification to Expedium Spine System
Summary page 4
…tem, VIPER®2 system (K061520/K111571/ K090648/K102701) EXPEDIUM® Spine System (K041119/K062174/K090230/ K090799) The SpineVision® Universal Lumbar Intuitive System (U.L.I.S.™ System), and Lumbar U…
Depuy Spine, Inc.2009—

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.20201

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 31 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
  • 14 of the 207 ancestors have a recall of any class.
  • Of its descendants, K200267 (Corentec Co., Ltd., 2020) has gone furthest, with 1 descendant of its own.

How does its category compare?

All MNI devices

MNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.

FDA decisions per year · MNI

1in 2017

2007: 202008: 232009: 182010: 162011: 172012: 192013: 142014: 62015: 122016: 72017: 1
2007high 23 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNI

168in 2016

2007: 82 days median2008: 64 days median2009: 86 days median2010: 74 days median2011: 111 days median2012: 75 days median2013: 77 days median2014: 104 days median2015: 54 days median2016: 168 days median
2007high 168 (2016) · low 54 (2015)2026

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

Recalls per year · MNI

1in 2018

2007: 262008: 82009: 32010: 12012: 12013: 42015: 12018: 1
2007high 26 (2007) · low 0 (2011)2026

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

Adverse event reports per year · MNI

80in 2025

2007: 832008: 1082009: 1382010: 1262011: 1462012: 2002013: 8242014: 3012015: 2602016: 1172017: 2472018: 1342019: 1882020: 1152021: 2702022: 2142023: 1222024: 1142025: 80
2007high 824 (2013) · low 80 (2025)2025

MAUDE reports naming product code MNI, 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
200720822683
200823648108
200918863138
201016741126
2011171110146
201219751200
201314774824
201461040301
201512541260
201671680117
20171—0247
20180—1134
20190—0188
20200—0115
20210—0270
20220—0214
20230—0122
20240—0114
20250—080
20260—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.1.S.™ and LUMIS™ 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.™ and LUMIS™ systems are pedicle screw systems indicated for…

Read the full statement (188 words)

When used for anterior screw fixation or as a posterior, non-pedicle system of the non-cervical spine, the U.L.1.S.™ and LUMIS™ 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.™ and LUMIS™ systems are pedicle screw systems 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 U.L.1.S.™ and LUMIS™ 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 (T10-S1):

* Degenerative spondylolisthesis with objective evidence of neurologic impairment

* Fracture

* Spinal tumor

* Failed previous fusion (pseudoarthrosis)

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Spinevision S.A.

5 FDA decisions under this applicant name. See the company

  • K153783SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFSpinevision S.A. · 2016
  • K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A. · 2014
  • K130302Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision U.L.I.S. Polyaxial Pedicle…Spinevision S.A. · 2013
  • K112607Spinevision Lumis (TM) Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision U.L.I.S.(TM)…Spinevision S.A. · 2012

Recent decisions in MNI

The MNI category page

  • K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd. · 2017
  • K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd. · 2016
  • K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc. · 2016
  • K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A. · 2016
  • K160320PremierShandong Weigao Orthopaedic Device Co., Ltd. · 2016

https://510kreport.com/device/K160124 · printed Nov 5, 2026

Cite this page

510(k) Report. “K160124: LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K160124

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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