510(k) Report

510(k) · Cleared

Cleared

Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision U.L.I.S. Pedicle Screw Fixation System

K133575510(k) TraditionalCleared Jun 30, 2014222-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. · MNH Orthosis, Spondylolisthesis Spinal Fixation

Cleared on Jun 30, 2014 as substantially equivalent to K112607 (Spinevision S.A., 2012) and 19 other predicates after a 222-day review. Its family tree reaches back 13 generations to 1985. 3 later devices descend from it.

Decided
Jun 30, 2014
Review
222 days
Class
Class II
Product code
MNH
Recalls
None
Predicates
20

Its longest line of descent runs back 13 generations to K853033 (1985). 206 ancestors in all, the oldest K781443 (1978). 3 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 ancestors2002: 10 other ancestors1996: 8 other ancestors2011: 3 other ancestors2008: 9 other ancestors2003: 10 other ancestors2001: 16 other ancestors2000: 15 other ancestors1999: 11 other ancestors1998: 15 other ancestors1997: 6 other ancestors1995: 8 other ancestors1994: 3 other ancestors1978: 1 other ancestor1993: 3 other ancestors1992: 5 other ancestors1990: 2 other ancestors1984: 1 other ancestor2016: 1 descendant cleared2020: 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 · 201119801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 18 other ancestors2 generations back: 45 other ancestors3 generations back: 43 other ancestors4 generations back: 61 other ancestors5 generations back: 21 other ancestors6 generations back: 5 other ancestors 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 1 descendant K111571 · 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 · 13 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 9 generations between
  3. 3 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
  4. 2 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
  5. 1 generation backK111571 Viper SystemsJohnson & Johnson · 2011
  6. This deviceK133575 Spinevision Lumis Cannulated Pedicle Screw Fixation System…Spinevision S.A. · 2014
  7. Descendant · cites it directly · 2 of its ownK160124 LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle…Spinevision S.A. · 2016
  8. Descendant · 2 generations on · 1 of its ownK200267 LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd. · 2020
  9. Descendant · 3 generations on · 0 of its ownK240180 Orthopeasia Spinal Fixation SystemOrthopeasia Co., Ltd. · 2024
Show all 13 generations
  1. Root · 13 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
  2. 12 generations backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
  3. 11 generations backK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
  4. 10 generations backK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
  5. 9 generations backK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
  6. 8 generations backK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
  7. 7 generations backK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
  8. 6 generations backK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
  9. 5 generations backK062174 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
  10. 4 generations backK063156 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2006
  11. 3 generations backK063741 Expedium Spine SystemDepuy Spine, Inc. · 2007
  12. 2 generations backK080313 Modification to Expedium Spine SystemDepuy Spine, Inc. · 2008
  13. 1 generation backK111571 Viper SystemsJohnson & Johnson · 2011
  14. This deviceK133575 Spinevision Lumis Cannulated Pedicle Screw Fixation System…Spinevision S.A. · 2014

Most influential descendants

Showing 3 of 3 · See all
  • 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

GenerationNumberDeviceApplicantDecidedRecalls
−13K853033Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd.1985—
−12K965221Ransford Cervical Fixation SystemSurgicraft, Ltd.1997—
−11K982322Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa)1998—
−10K002733Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2000—
−9K013222Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed2001—
−8K022190Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed2002—
−7K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed2003—
−6K041203Summit Oct Spinal SystemDepuy Spine, Inc.2004—
−5K062174Modification to Expedium Spine SystemDepuy Spine, Inc.2006—
−4K063156Modification to Expedium Spine SystemDepuy Spine, Inc.2006—
−3K063741Expedium Spine SystemDepuy Spine, Inc.2007—
−2K080313Modification to Expedium Spine SystemDepuy Spine, Inc.2008—
−1K111571Viper SystemsJohnson & Johnson2011—
0 (this device)K133575Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision…Spinevision S.A.2014—
+1K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw…Spinevision S.A.2016—
+2K200267LOSPA® IS™ Spinal Fixation SystemCorentec Co., Ltd.2020—
+3K240180Orthopeasia 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
201610
202010
202410
FIG. 1 — Lineage of K133575, 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 MNH? 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? (20)

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
*K112607Spinevision Lumis (TM) Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…
Summary page 1
…MNI, MNH, KWQ, KWP CFR section 888.3070, 888.3050 [UM IST M Pedicle Screw Fixation System (1<112607/K<130302) U. L.I.S. TM Pedicle Screw Fixation System (Ki112607/1<130302)…
Spinevision S.A.2012—
*K130302Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision…
Summary page 1
…I, MNH, KWQ, KWP CFR section 888.3070, 888.3050 [UM IST M Pedicle Screw Fixation System (1<112607/K<130302) U. L.I.S. TM Pedicle Screw Fixation System (Ki112607/1<130302)…
Spinevision S.A.2013—
*K013301Uni-T Spinal System
Summary page 1
…U. L.I.S. TM Pedicle Screw Fixation System (Ki112607/1<130302) UNI-THREAD Spinal System(K013301) Scient'x Polyaxial LP (K062912) Xia Spinal Sys…
Spine Vision, Inc.2002—
*K062912Scient'x Spinal System
Summary page 1
…ion System (Ki112607/1<130302) UNI-THREAD Spinal System(K013301) Scient'x Polyaxial LP (K062912) Xia Spinal System (K050461/K052761/K060361/K060748/ Legally marketed…
Scient'X2007—
*K050461Xia 4.5 Spinal System
Summary page 1
…UNI-THREAD Spinal System(K013301) Scient'x Polyaxial LP (K062912) Xia Spinal System (K050461/K052761/K060361/K060748/ Legally marketed K071373/K113666) predicate devices VIPER…
Stryker Spine2005—
*K052761Modification to: Xia 4.5 Spinal System
Summary page 1
…HREAD Spinal System(K013301) Scient'x Polyaxial LP (K062912) Xia Spinal System (K050461/K052761/K060361/K060748/ Legally marketed K071373/K113666) predicate devices VIPER® System…
Stryker Spine2005—
*K060361Xia Spinal System, Xia 4.5 Spinal System
Summary page 1
…inal System(K013301) Scient'x Polyaxial LP (K062912) Xia Spinal System (K050461/K052761/K060361/K060748/ Legally marketed K071373/K113666) predicate devices VIPER® System, VIPER®…
Stryker Spine20061
*K060748Modification to Xia 4.5 Spinal System
Summary page 1
…tem(K013301) Scient'x Polyaxial LP (K062912) Xia Spinal System (K050461/K052761/K060361/K060748/ Legally marketed K071373/K113666) predicate devices VIPER® System, VIPER®2 system…
Stryker Spine2006—
*K071373Stryker Spine Xia Iii Spinal System
Summary page 1
…Scient'x Polyaxial LP (K062912) Xia Spinal System (K050461/K052761/K060361/K060748/ Legally marketed K071373/K113666) predicate devices VIPER® System, VIPER®2 system (KO061520/K(111S71/…
Stryker Spine20071
*K113666Xia 3 Spinal System
Summary page 1
…nt'x Polyaxial LP (K062912) Xia Spinal System (K050461/K052761/K060361/K060748/ Legally marketed K071373/K113666) predicate devices VIPER® System, VIPER®2 system (KO061520/K(111S71/…
Stryker Spine2012—
*K061520Viper Spine System
Summary page 1
…tem (K050461/K052761/K060361/K060748/ Legally marketed K071373/K113666) predicate devices VIPER® System, VIPER®2 system (KO061520/K(111S71/ 1(090648/K 102701) EXPEDIUM® Spine Sy…
Depuy Spine, Inc.2006—
*K111571Viper SystemsJohnson & Johnson2011—
*K090648Viper 2 System
Summary page 1
…K071373/K113666) predicate devices VIPER® System, VIPER®2 system (KO061520/K(111S71/ 1(090648/K 102701) EXPEDIUM® Spine System (K041119/K062174/K09023D/…
Depuy Spine, Inc.2009—
*K102701Viper Spine System
Summary page 1
…K071373/K113666) predicate devices VIPER® System, VIPER®2 system (KO061520/K(111S71/ 1(090648/K 102701) EXPEDIUM® Spine System (K041119/K062174/K09023D/…
Depuy Spine, Inc.2010—
*K041119Expedium Spine System
Summary page 1
…® System, VIPER®2 system (KO061520/K(111S71/ 1(090648/K 102701) EXPEDIUM® Spine System (K041119/K062174/K09023D/ K090799) DePuy Spine - Moss Mi…
Depuy Spine, Inc.2004—
*K062174Modification to Expedium Spine System
Summary page 1
…, VIPER®2 system (KO061520/K(111S71/ 1(090648/K 102701) EXPEDIUM® Spine System (K041119/K062174/K09023D/ K090799) DePuy Spine - Moss Miami-tita…
Depuy Spine, Inc.2006—
*K090230Expedium Spine SystemDepuy Spine, Inc.2009—
*K090799Modification to Expedium Spine System
Summary page 1
…1(090648/K 102701) EXPEDIUM® Spine System (K041119/K062174/K09023D/ K090799) DePuy Spine - Moss Miami-titanium (1(955348) __________________Alphatec…
Depuy Spine, Inc.2009—
*K955348Titanium Moss Miami Spinal System
Summary page 1
…M® Spine System (K041119/K062174/K09023D/ K090799) DePuy Spine - Moss Miami-titanium (1(955348) __________________Alphatec Zodiac (K071890) K133575 - page 2 of 4…
Depuy, Inc.1996—
*K071890Zodiac 4.0 Polyaxial Spinal Fixation System
Summary page 1
…K090799) DePuy Spine - Moss Miami-titanium (1(955348) __________________Alphatec Zodiac (K071890) K133575 - page 2 of 4 The SpineVision®D Universal Lumbar Intuitive System (U.L. I.S. T…
Alphatec Spine, Inc.20071

Also cleared against K112607: 2 other devices →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A.20162

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 29 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
  • 14 of the 206 ancestors have a recall of any class.
  • Of its descendants, K160124 (Spinevision S.A., 2016) has gone furthest, with 2 descendants of its own.
  • 2 other devices also cite its predicate K112607.

How does its category compare?

All MNH devices

MNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · MNH

8in 2016

2007: 52008: 132009: 132010: 102011: 172012: 72013: 102014: 122015: 102016: 8
2007high 17 (2011) · low 0 (2017)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNH

93in 2016

2007: 123 days median2008: 65 days median2009: 151 days median2010: 106 days median2011: 171 days median2012: 93 days median2013: 124 days median2014: 140 days median2015: 99 days median2016: 93 days median
2007high 171 (2011) · low 65 (2008)2026

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

Recalls per year · MNH

1in 2016

2009: 72012: 12013: 12016: 1
2007high 7 (2009) · low 0 (2007)2026

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

Adverse event reports per year · MNH

89in 2025

2007: 182008: 302009: 452010: 592011: 1072012: 4332013: 4642014: 2862015: 1522016: 2162017: 1742018: 1292019: 4032020: 4322021: 5312022: 2652023: 1212024: 3022025: 89
2007high 531 (2021) · low 18 (2007)2025

MAUDE reports naming product code MNH, 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
20075123018
20081365030
200913151745
201010106059
2011171710107
20127931433
2013101241464
2014121400286
201510990152
20168931216
20170—0174
20180—0129
20190—0403
20200—0432
20210—0531
20220—0265
20230—0121
20240—0302
20250—089
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.I.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 * curvatures (i.e. scoliosis, kyphosis, and/or lordosis) * tumors * failed previous fusion (pseudoarthrosis) The U.L.I.S. and…

Read the full statement (202 words)

When used for anterior screw fixation or as a posterior, non-pedicle system of the non-cervical spine, the U.L.I.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

* curvatures (i.e. scoliosis, kyphosis, and/or lordosis)

* 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.I.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 (TIO0-Slj):

* degenerative spondylolisthesis with objective evidence of neurologic impairment

* fracture

* curvatures (i.e. scoliosis, kyphosis, and/or lordosis)

* spinal tumor

* failed previous fusion (pseudoarthrosis)

Indications for use as stated in the FDA summary.

Also cleared against K112607

2 other devices cite the same predicate.

  • K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A. · 2016
  • K130302Spinevision Lumis Cannulated Polyaxial Pedicle Screw Fixation System, Spinevision U.L.I.S. Polyaxial Pedicle…Spinevision S.A. · 2013

More from Spinevision S.A.

5 FDA decisions under this applicant name. See the company

  • K153783SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIFSpinevision S.A. · 2016
  • K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A. · 2016
  • 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 MNH

The MNH category page

  • K162066Reliance Spinal Screw SystemReliance Medical Systems, LLC · 2016
  • K162801CastleLoc Spinal Fixation SystemL&K BIOMED Co., Ltd. · 2016
  • K162143FixxSure® X-LinkInnovasis, Inc. · 2016
  • K161151Spinal fixation systemCanwell Medical Co., Ltd. · 2016
  • K162189ANAX™ 5.5 Spinal SystemU&I Corporation · 2016

https://510kreport.com/device/K133575 · printed Nov 5, 2026

Cite this page

510(k) Report. “K133575: Spinevision Lumis Cannulated Pedicle Screw Fixation System, Spinevision 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/K133575

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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