510(k) Report

510(k) · Cleared

Cleared

Modification to Vertex Reconstruction System

K070742510(k) TraditionalCleared Sep 14, 2007182-day reviewClass II21 CFR 888.3050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medtronic Sofamor Danek · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Sep 14, 2007 as substantially equivalent to K042789 (Medtronic Sofamor Danek, 2004) and 8 other predicates after a 182-day review. Its family tree reaches back 11 generations to 2001. 150 later devices descend from it.

Decided
Sep 14, 2007
Review
182 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
9

Its longest line of descent runs back 11 generations to K003155 (2001). 65 ancestors in all, the oldest K841189 (1984). 150 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2007: 1 other ancestor2006: 4 other ancestors2005: 8 other ancestors2004: 15 other ancestors2002: 5 other ancestors2001: 5 other ancestors1998: 2 other ancestors2003: 5 other ancestors1997: 1 other ancestor2000: 5 other ancestors1985: 1 other ancestor1999: 1 other ancestor1984: 1 other ancestor2013: 5 descendants cleared2011: 2 descendants cleared2009: 1 descendant cleared2018: 8 descendants cleared2017: 12 descendants cleared2008: 1 descendant cleared2016: 6 descendants cleared2012: 5 descendants cleared2025: 12 descendants cleared2014: 9 descendants cleared2026: 13 descendants cleared2022: 9 descendants cleared2021: 8 descendants cleared2023: 16 descendants cleared2020: 16 descendants cleared2019: 6 descendants cleared2015: 8 descendants cleared2024: 13 descendants clearedK003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001K012254 · VBR · Osteotech, Inc. · 2001×3: 3 generations cleared close together, K021791 (2002), K023570 (2002), K030601 (2003) ×2: 2 generations cleared close together, K040536 (2004), K041556 (2004) K043561 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004×3: 3 generations cleared close together, K060719 (2006), K061938 (2006), K062427 (2006) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 8 other ancestors2 generations back: 9 other ancestors3 generations back: 6 other ancestors4 generations back: 12 other ancestors5 generations back: 18 other ancestors6 generations back: 1 other ancestor 1 generation forward: 6 descendants2 generations forward: 19 descendants3 generations forward: 23 descendants4 generations forward: 27 descendants5 generations forward: 22 descendants6 generations forward: 19 descendants7 generations forward: 14 descendants8 generations forward: 12 descendants9 generations forward: 6 descendants10 generations forward: 2 descendants K062427 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2006K061938 · Verte-Stack Spinal System · Medtronic Sofamor Danek, Inc. · 2006K060719 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2006K043561 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K041556 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K040536 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2004K030601 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2003K023570 · Modification to Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K021791 · Verte-Stack Spinal System · Medtronic Sofamor Danek · 2002K012254 · VBR · Osteotech, Inc. · 2001K003155 · Vertebral Body Replacement · Osteotech, Inc. · 2001−10−50+5+10
  1. Root · 11 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 7 generations between
  3. 3 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  4. 2 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
  5. 1 generation backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  6. This deviceK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
  7. Descendant · cites it directly · 106 of its ownK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
  8. Descendant · 2 generations on · 102 of its ownK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
  9. Descendant · 3 generations on · 75 of its ownK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
  10. Descendant · 4 generations on · 70 of its ownK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
  11. Descendant · 3 generations on · 67 of its ownK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
Show all 11 generations
  1. Root · 11 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 10 generations backK012254 VBROsteotech, Inc. · 2001
  3. 9 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 8 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 7 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 6 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  7. 5 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  8. 4 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  9. 3 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  10. 2 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
  11. 1 generation backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  12. This deviceK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007

Showing 5 of 150 descendants. See all descendants

Descendants cleared per year

2008: 12009: 12011: 22012: 52013: 52014: 92015: 82016: 62017: 122018: 82019: 62020: 162021: 82022: 92023: 162024: 132025: 122026: 13
2008high 16 (2020) · low 0 (2010)2026

Most influential descendants

Showing 5 of 150 · See all
  • K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011 · cites it directly106descendants
  • K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012 · 2 generations on102descendants
  • K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC) · 2013 · 3 generations on75descendants
  • K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013 · 4 generations on70descendants
  • K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · 3 generations on67descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−11K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−10K012254VBROsteotech, Inc.2001—
−9K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−8K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−7K030601Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−6K040536Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−5K041556Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−4K043561Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−3K060719Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
−2K061938Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2006—
−1K062427Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
0 (this device)K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007—
+1K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011—
+2K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012—
+3K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)20132
+4K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2013—
+3K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)20141

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198510
199710
199820
199910
200050
200150
200250
200350
2004150
200580
200640
200710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201120
201250
201350
201490
201580
201660
2017120
201880
201960
2020160
202180
202290
2023160
2024130
2025120
2026130
FIG. 1 — Lineage of K070742, 2001–2026Source: 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 KWP? 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
Get a 510(k) Report

What was it cleared against? (9)

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
*K042789Vertex Reconstruction System
Summary page 2
…stantially equivalent to other commercially available posterior fixation systems and other pre-enactment devices including the VERTEX® Reconstruction System (K042789, SE 12/21/04; K052402, SE 09/23/05; K052734, SE 10/21/05; K053483, SE 01/05/06), the TRAVERSETM OCT Spinal Fixation S…
Medtronic Sofamor Danek2004—
*K052402Vertex Reconstruction System
Summary page 2
…to other commercially available posterior fixation systems and other pre-enactment devices including the VERTEX® Reconstruction System (K042789, SE 12/21/04; K052402, SE 09/23/05; K052734, SE 10/21/05; K053483, SE 01/05/06), the TRAVERSETM OCT Spinal Fixation System (K062879, SE 12/…
Medtronic Sofamor Danek2005—
*K052734Modification to: Vertex Reconstruction System
Summary page 2
…available posterior fixation systems and other pre-enactment devices including the VERTEX® Reconstruction System (K042789, SE 12/21/04; K052402, SE 09/23/05; K052734, SE 10/21/05; K053483, SE 01/05/06), the TRAVERSETM OCT Spinal Fixation System (K062879, SE 12/22/06), the CD HORIZON® Spin…
Medtronic Sofamor Danek2005—
*K053483Modification to Vertex Reconstruction System
Summary page 2
…xation systems and other pre-enactment devices including the VERTEX® Reconstruction System (K042789, SE 12/21/04; K052402, SE 09/23/05; K052734, SE 10/21/05; K053483, SE 01/05/06), the TRAVERSETM OCT Spinal Fixation System (K062879, SE 12/22/06), the CD HORIZON® Spinal System (K0613…
Medtronic Sofamor Danek2006—
*K062879Traverse Oct Spinal Fixation System
Summary page 2
…X® Reconstruction System (K042789, SE 12/21/04; K052402, SE 09/23/05; K052734, SE 10/21/05; K053483, SE 01/05/06), the TRAVERSETM OCT Spinal Fixation System (K062879, SE 12/22/06), the CD HORIZON® Spinal System (K061304, SE 07/18/06; K063417, SE 01/1 8/2007), the VERTE-STACK® Spinal…
Medtronic Sofamor Danek, Inc.2006—
*K061304CD Horizon Spinal System
Summary page 2
…09/23/05; K052734, SE 10/21/05; K053483, SE 01/05/06), the TRAVERSETM OCT Spinal Fixation System (K062879, SE 12/22/06), the CD HORIZON® Spinal System (K061304, SE 07/18/06; K063417, SE 01/1 8/2007), the VERTE-STACK® Spinal System (K062427, SE 09/12/06) and the TSRH® Spinal System (…
Medtronic Sofamor Danek2006—
*K063417Modification to CD Horizon Spinal System
Summary page 2
…4, SE 10/21/05; K053483, SE 01/05/06), the TRAVERSETM OCT Spinal Fixation System (K062879, SE 12/22/06), the CD HORIZON® Spinal System (K061304, SE 07/18/06; K063417, SE 01/1 8/2007), the VERTE-STACK® Spinal System (K062427, SE 09/12/06) and the TSRH® Spinal System (K062807, SE 11/0…
Medtronic Sofamor Danek2007—
*K062427Verte-Stack Spinal System
Summary page 2
…Fixation System (K062879, SE 12/22/06), the CD HORIZON® Spinal System (K061304, SE 07/18/06; K063417, SE 01/1 8/2007), the VERTE-STACK® Spinal System (K062427, SE 09/12/06) and the TSRH® Spinal System (K062807, SE 11/06/06). The results of mechanical testing performed for the subje…
Medtronic Sofamor Danek2006—
*K062807TSRH Spinal System
Summary page 2
…CD HORIZON® Spinal System (K061304, SE 07/18/06; K063417, SE 01/1 8/2007), the VERTE-STACK® Spinal System (K062427, SE 09/12/06) and the TSRH® Spinal System (K062807, SE 11/06/06). The results of mechanical testing performed for the subject VERTEX® Reconstruction System components w…
Medtronic Sofamor Danek, Inc.2006—

Also cleared against K042789: 9 other devices →

What descends from it? (150)

See all 150

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011106
K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201339
K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc.201716
K073420Blackstone Ascent Multiaxial ScrewsBlackstone Medical, Inc.20089
K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc.20188
K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek20097

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 6 years and passes through 3 companies; a new generation was cleared every 6 months on median.
  • 4 of the 65 ancestors have a recall of any class.
  • Of its descendants, K110522 (Medtronic Sofamor Danek USA, Inc., 2011) has gone furthest, with 106 descendants of its own.
  • 9 other devices also cite its predicate K042789.

How does its category compare?

All KWP devices

KWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · KWP

9in 2015

2007: 142008: 132009: 122010: 142011: 122012: 182013: 122014: 132015: 9
2007high 18 (2012) · low 0 (2016)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KWP

113in 2015

2007: 96 days median2008: 50 days median2009: 89 days median2010: 186 days median2011: 67 days median2012: 112 days median2013: 99 days median2014: 138 days median2015: 113 days median
2007high 186 (2010) · low 50 (2008)2026

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

Recalls per year · KWP

2in 2022

2007: 22008: 12009: 232010: 22011: 62012: 12013: 32015: 12016: 32018: 12019: 22022: 2
2007high 23 (2009) · low 0 (2014)2026

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

Adverse event reports per year · KWP

494in 2025

2007: 2102008: 5942009: 6822010: 4742011: 7922012: 9182013: 1,0902014: 1,0222015: 1,3482016: 1,3792017: 8642018: 6572019: 5182020: 7962021: 5252022: 3352023: 3322024: 4362025: 494
2007high 1,379 (2016) · low 210 (2007)2025

MAUDE reports naming product code KWP, 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
200714962210
200813501594
2009128923682
2010141862474
201112676792
2012181121918
2013129931,090
20141313801,022
2015911311,348
20160—31,379
20170—0864
20180—1657
20190—2518
20200—0796
20210—0525
20220—2335
20230—0332
20240—0436
20250—0494
20260—0—

What is it indicated for?

When intended to promote fusion of the occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-T3), the VERTEX® Reconstruction System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. Occipitocervical Components: Plate RodlPlates/Rods/Occipital…

Read the full statement (259 words)

When intended to promote fusion of the occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-T3), the VERTEX® Reconstruction System is indicated for the following:

DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.

Occipitocervical Components: Plate RodlPlates/Rods/Occipital Screws/Hooks

The occipitocervical plate rods, plates, rods, occipital screws, and hooks are intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the occipitocervical junction and the cervical spine. When used to treat these occipitocervical and cervical conditions, these screws are limited to occipital fixation only. The screws are not intended to be placed in the cervical spine.

Occipitocervical constructs require bilateral fixation to C2 and below. Note: Segmental fixation is recommended for these constructs.

Hooks and Rods

The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (Cl-T3) spine.

Multi-axial Screws/Connectors

The use of multi-axial screws are limited to placement in Tl-T3. The screws are not intended to be placed in the cervical spine.

Titanium ATLAS® Cable System to be used with the VERTEX® Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.

In order to achieve additional levels of fixation, the VERTEX® Reconstruction System may be connected to the CD HORIZON® Spinal System rods with the VERTEX® rod connectors. Refer to the CD HORIZON® Spinal System package insert for a list of the CD HORIZON® Spinal System indications of use.

Indications for use as stated in the FDA summary.

Also cleared against K042789

9 other devices cite the same predicate.

  • K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2013
  • K121191Vertex Rcconstruction SystemMedtronic Sofamor Danek, Inc. · 2012
  • K093434Vertex Reconstruction System and Vertex Select Reconstruction SystemMedtronic Sofamor Danek · 2009
  • K090714Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek · 2009
  • K082728Vertex Recontruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2009
  • K083071Vertex Reconstruction SystemMedtronic Sofamor Danek · 20081 recall

More from Medtronic Sofamor Danek

154 FDA decisions under this applicant name. See the company

  • K212428Centerpiece Plate Fixation SystemMedtronic Sofamor Danek · 2021
  • K201267Adaptix Interbody System with Titan nanoLOCK Surface TechnologyMedtronic Sofamor Danek · 2020
  • K173125T2 STRATOSPHERE™ Expandable Corpectomy SystemMedtronic Sofamor Danek · 2017
  • K172199ELEVATE Spinal System, CAPSTONE PTC Spinal System, CRESCENT Spinal System, CRESCENT Spinal System TitaniumMedtronic Sofamor Danek · 2017
  • K171031CRESCENT™ Spinal SystemMedtronic Sofamor Danek · 2017

Recent decisions in KWP

The KWP category page

  • K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd. · 2015
  • K150753OASYS SystemStryker Corporation · 2015
  • K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc. · 2015
  • K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC · 2015
  • K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) · 20153 recalls

https://510kreport.com/device/K070742 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070742: Modification to Vertex Reconstruction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070742

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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