510(k) Report

510(k) · Cleared

Cleared

Modification to Vertex Reconstruction System

K080805510(k) SpecialCleared Apr 18, 200828-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 Apr 18, 2008 after a 28-day review. The FDA summary names its predicate without a number. 143 later devices descend from it.

Decided
Apr 18, 2008
Review
28 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
0

143 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2013: 5 descendants cleared2009: 2 descendants cleared2018: 8 descendants cleared2012: 4 descendants cleared2011: 2 descendants cleared2017: 12 descendants cleared2025: 11 descendants cleared2014: 9 descendants cleared2026: 13 descendants cleared2020: 16 descendants cleared2019: 5 descendants cleared2015: 8 descendants cleared2022: 9 descendants cleared2021: 8 descendants cleared2023: 13 descendants cleared2016: 5 descendants cleared2024: 13 descendants cleared20052010201520202025
  1. This deviceK080805 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2008
  2. Descendant · cites it directly · 138 of its ownK091365 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Soafamor Danek · 2009
  3. Descendant · 2 generations on · 106 of its ownK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
  4. Descendant · 2 generations on · 102 of its ownK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
  5. Descendant · 3 generations on · 75 of its ownK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
  6. Descendant · 4 generations on · 70 of its ownK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013

Showing 5 of 143 descendants. See all descendants

Descendants cleared per year

2009: 22011: 22012: 42013: 52014: 92015: 82016: 52017: 122018: 82019: 52020: 162021: 82022: 92023: 132024: 132025: 112026: 13
2009high 16 (2020) · low 0 (2010)2026

Most influential descendants

Showing 5 of 143 · See all
  • K091365Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Soafamor Danek · 2009 · cites it directly138descendants
  • K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011 · 2 generations on106descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K080805Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2008—
+1K091365Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Soafamor Danek2009—
+2K110522Vertex 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—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200920
201120
201240
201350
201490
201580
201650
2017120
201880
201950
2020160
202180
202290
2023130
2024130
2025110
2026130
FIG. 1 — Lineage of K080805, 2008–2026Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*—VERTEX® Reconstruction System
Named without a submission number
—

What descends from it? (143)

See all 143

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

NumberDeviceApplicantDecidedDescendants
K091365Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Soafamor Danek2009138
K123656Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.201339
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?

  • Of its descendants, K091365 (Medtronic Soafamor Danek, 2009) has gone furthest, with 138 descendants of its own.

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. 2008, 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 Rod/Plates/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 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 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.

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/K080805 · printed Nov 6, 2026

Cite this page

510(k) Report. “K080805: 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/K080805

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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