510(k) Report

510(k) · Cleared

Cleared

Vertex Reconstruction System, Vertex Select Reconstruction System

K110522510(k) SpecialCleared Apr 1, 201137-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 USA, Inc. · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Apr 1, 2011 as substantially equivalent to K003780 (Medtronic Sofamor Danek, Inc., 2001) and 6 other predicates after a 37-day review. Its family tree reaches back 12 generations to 2001. 106 later devices descend from it.

Decided
Apr 1, 2011
Review
37 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
7

Its longest line of descent runs back 12 generations to K003155 (2001). 80 ancestors in all, the oldest K841189 (1984). 106 later devices descend from it, 6 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 3 other ancestors2008: 3 other ancestors2007: 2 other ancestors2001: 6 other ancestors2006: 4 other ancestors2005: 10 other ancestors2004: 17 other ancestors2002: 7 other ancestors1998: 2 other ancestors2003: 5 other ancestors1997: 1 other ancestor2000: 5 other ancestors1985: 1 other ancestor1999: 1 other ancestor1984: 1 other ancestor2013: 4 descendants cleared2012: 4 descendants cleared2025: 10 descendants cleared2014: 8 descendants cleared2018: 5 descendants cleared2017: 8 descendants cleared2015: 7 descendants cleared2020: 13 descendants cleared2016: 2 descendants cleared2023: 9 descendants cleared2021: 6 descendants cleared2024: 10 descendants cleared2019: 4 descendants cleared2022: 7 descendants cleared2026: 9 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) K070742 · Modification to Vertex Reconstruction System · Medtronic Sofamor Danek · 200719801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 6 other ancestors2 generations back: 14 other ancestors3 generations back: 11 other ancestors4 generations back: 6 other ancestors5 generations back: 12 other ancestors6 generations back: 18 other ancestors7 generations back: 1 other ancestor 1 generation forward: 6 descendants2 generations forward: 8 descendants3 generations forward: 16 descendants4 generations forward: 21 descendants5 generations forward: 20 descendants6 generations forward: 14 descendants7 generations forward: 13 descendants8 generations forward: 6 descendants9 generations forward: 2 descendants K070742 · Modification to Vertex Reconstruction System · Medtronic Sofamor Danek · 2007K062427 · 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
  1. Root · 12 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 8 generations between
  3. 3 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
  4. 2 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  5. 1 generation backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
  6. This deviceK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
  7. Descendant · cites it directly · 102 of its ownK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
  8. Descendant · 2 generations on · 75 of its ownK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
  9. Descendant · 3 generations on · 70 of its ownK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013
  10. Descendant · 2 generations on · 67 of its ownK133746 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · Recalled
  11. Descendant · 3 generations on · 30 of its ownK143248 Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014
Show all 12 generations
  1. Root · 12 generations backK003155 Vertebral Body ReplacementOsteotech, Inc. · 2001
  2. 11 generations backK012254 VBROsteotech, Inc. · 2001
  3. 10 generations backK021791 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  4. 9 generations backK023570 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2002
  5. 8 generations backK030601 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2003
  6. 7 generations backK040536 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  7. 6 generations backK041556 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  8. 5 generations backK043561 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2004
  9. 4 generations backK060719 Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  10. 3 generations backK061938 Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
  11. 2 generations backK062427 Verte-Stack Spinal SystemMedtronic Sofamor Danek · 2006
  12. 1 generation backK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
  13. This deviceK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011

Showing 5 of 106 descendants. See all descendants

Descendants cleared per year

2012: 42013: 42014: 82015: 72016: 22017: 82018: 52019: 42020: 132021: 62022: 72023: 92024: 102025: 102026: 9
2012high 13 (2020) · low 2 (2016)2026

Most influential descendants

Showing 5 of 106 · See all
  • K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012 · cites it directly102descendants
  • K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC) · 2013 · 2 generations on75descendants
  • K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013 · 3 generations on70descendants
  • K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2014 · 2 generations on67descendants
  • K143248Reform Pedicle Screw SystemPrecision Spine, Inc. · 2014 · 3 generations on30descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K003155Vertebral Body ReplacementOsteotech, Inc.2001—
−11K012254VBROsteotech, Inc.2001—
−10K021791Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−9K023570Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2002—
−8K030601Verte-Stack Spinal SystemMedtronic Sofamor Danek2003—
−7K040536Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−6K041556Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−5K043561Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2004—
−4K060719Modification to Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
−3K061938Verte-Stack Spinal SystemMedtronic Sofamor Danek, Inc.2006—
−2K062427Verte-Stack Spinal SystemMedtronic Sofamor Danek2006—
−1K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007—
0 (this device)K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011—
+1K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012—
+2K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)20132
+3K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2013—
+2K133746Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)20141
+3K143248Reform Pedicle Screw SystemPrecision Spine, Inc.2014—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198410
198510
199710
199820
199910
200050
200160
200270
200350
2004170
2005100
200640
200720
200830
200930

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201240
201340
201480
201570
201620
201780
201850
201940
2020130
202160
202270
202390
2024100
2025100
202690
FIG. 1 — Lineage of K110522, 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? (7)

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
*K003780Vertex Reconstruction System
Summary page 1
…Date> device(s) to which Number Cleared - equivalence is claimed K003780 Vertex Reconstruction System 9/28/01 K062447 Traverse OCT Spinal…
Medtronic Sofamor Danek, Inc.2001—
*K062447Traverse Oct Spinal Fixation System
Summary page 1
…Cleared - equivalence is claimed K003780 Vertex Reconstruction System 9/28/01 K062447 Traverse OCT Spinal Fixation System 10/15/07 K070742 Modification to V…
Medtronic Sofamor Danek, Inc.2007—
*K070742Modification to Vertex Reconstruction System
Summary page 1
…9/28/01 K062447 Traverse OCT Spinal Fixation System 10/15/07 K070742 Modification to Vertex Reconstruction System 9/14/07 K082728 Vertex Recons…
Medtronic Sofamor Danek2007—
*K082728Vertex Recontruction System, Vertex Select Reconstruction System
Summary page 1
…ystem 10/15/07 K070742 Modification to Vertex Reconstruction System 9/14/07 K082728 Vertex Reconstruction System, Vertex Select 1/16/09 Reconstructio…
Medtronic Sofamor Danek USA, Inc.2009—
*K083071Vertex Reconstruction System
Summary page 1
…28 Vertex Reconstruction System, Vertex Select 1/16/09 Reconstruction System K083071 Vertex Reconstruction System 11/14/08 K09071 4 Vertex Recon…
Medtronic Sofamor Danek20081
*K090714Vertex Reconstruction System, Vertex Select Reconstruction System
Summary page 1
…Reconstruction System K083071 Vertex Reconstruction System 11/14/08 K09071 4 Vertex Reconstruction System, Vertex Select 4/17/09 Reconstruction…
Medtronic Sofamor Danek2009—
*K091365Vertex Reconstruction System, Vertex Select Reconstruction System
Summary page 1
…4 Vertex Reconstruction System, Vertex Select 4/17/09 Reconstruction SystemI K091365 Vertex Reconstruction System, Vertex Select 8/6/09 Reconstruction…
Medtronic Soafamor Danek2009—

Also cleared against K003780: 20 other devices →

What descends from it? (106)

See all 106

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

NumberDeviceApplicantDecidedDescendants
K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012102
K122378Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)20127
K121877Gibralt Occipital Plate Screws, Set Screw, Gibralt Occipital System Articulating Rod…Exactech, Inc.20134
K251725ANAX™ OCT Spinal SystemCg Medtech Co., Ltd.20250
K181350ASTRA-OCT Spine SystemSpinecraft, LLC20180
K140734Nextgen Altius Oct SystemEbi, LLC20140

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 10 years and passes through 4 companies; a new generation was cleared every 9 months on median.
  • 6 of the 80 ancestors have a recall of any class.
  • Of its descendants, K113593 (Biomet Spine (Aka Ebi, LLC), 2012) has gone furthest, with 102 descendants of its own.
  • 20 other devices also cite its predicate K003780.

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. 2011, 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 as an adjunct to fusion of the occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-T3), the VERTEX® Reconstruction System is indicated for skeletally mature patients using allograft and/or autograft 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…

Read the full statement (269 words)

When intended as an adjunct to fusion of the occipitocervical spine, cervical spine, and the thoracic spine, (Occiput-T3), the VERTEX® Reconstruction System is indicated for skeletally mature patients using allograft and/or autograft 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 Rod/Plates/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 (C1-T3) spine.

Multi-axial Screws/Connectors

The use of multi-axial screws are limited to placement in T1-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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K003780

20 other devices cite the same predicate.

  • K180851VERTEX™ Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2018
  • K163375INFINITY™ OCT SystemMedtronic Sofamor Danek USA, Inc. · 20175 recalls
  • K133556Virage Oct Spinal Fixation SystemZimmer Spine, Inc. · 20142 recalls
  • K121979Pass Oct Spinal SystemMedicrea International · 2013
  • K122292Reliance Posterior Cervical- Thoracic SystemReliance Medical Systems, LLC · 2012
  • K121136Renoir Posterior Cervial Fixation SystemAccel Spine · 2012

More from Medtronic Sofamor Danek USA, Inc.

366 FDA decisions under this applicant name. See the company

  • P000058/S095Infuse Bone Graft/LT-Cage Lumbar Tapered Fusion DeviceMedtronic Sofamor Danek USA, Inc. · 2026
  • P000054/S075Infuse Bone GraftMedtronic Sofamor Danek USA, Inc. · 2026
  • P000058/S099Infuse TM Bone Graft/Medtronic lnterbody Fusion DeviceMedtronic Sofamor Danek USA, Inc. · 2026
  • P000054/S078Infuse™ Bone GraftMedtronic Sofamor Danek USA, Inc. · 2026
  • K253011Catalyft PL Expandable Interbody SystemMedtronic Sofamor Danek USA, Inc. · 2026

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/K110522 · printed Nov 6, 2026

Cite this page

510(k) Report. “K110522: Vertex Reconstruction System, Vertex Select 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/K110522

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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