510(k) Report

510(k) · Cleared

Recalled · 2011

Vertex Reconstruction System

K042498510(k) SpecialCleared Oct 7, 200423-day reviewClass II21 CFR 888.3050Recalls 1

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 Oct 7, 2004 as substantially equivalent to K003780 (Medtronic Sofamor Danek, Inc., 2001) after a 23-day review. Its family tree reaches back 1 generation to 2001. 188 later devices descend from it. It has been recalled once.

Decided
Oct 7, 2004
Review
23 days
Class
Class II
Product code
KWP
Recalls
1
Predicates
1

Its longest line of descent runs back 1 generation to K003780 (2001). 188 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2006: 3 descendants cleared2005: 2 descendants cleared2007: 4 descendants cleared2013: 8 descendants cleared2009: 3 descendants cleared2017: 12 descendants cleared2008: 5 descendants cleared2014: 11 descendants cleared2012: 7 descendants cleared2015: 11 descendants cleared2011: 5 descendants cleared2018: 9 descendants cleared2023: 19 descendants cleared2020: 17 descendants cleared2016: 8 descendants cleared2022: 9 descendants cleared2026: 13 descendants cleared2021: 9 descendants cleared2025: 12 descendants cleared2010: 2 descendants cleared2019: 6 descendants cleared2024: 13 descendants clearedK003780 · Vertex Reconstruction System · Medtronic Sofamor Danek, Inc. · 2001200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 13 descendants3 generations forward: 28 descendants4 generations forward: 25 descendants5 generations forward: 31 descendants6 generations forward: 30 descendants7 generations forward: 22 descendants8 generations forward: 15 descendants9 generations forward: 13 descendants10 generations forward: 6 descendants11 generations forward: 2 descendants K003780 · Vertex Reconstruction System · Medtronic Sofamor Danek, Inc. · 20010+5+10
  1. Root · 1 generation backK003780 Vertex Reconstruction SystemMedtronic Sofamor Danek, Inc. · 2001
  2. This deviceK042498 Vertex Reconstruction SystemMedtronic Sofamor Danek · 2004
  3. Descendant · cites it directly · 187 of its ownK052180 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2005
  4. Descendant · cites it directly · 175 of its ownK052734 Modification to: Vertex Reconstruction SystemMedtronic Sofamor Danek · 2005
  5. Descendant · 2 generations on · 151 of its ownK062879 Traverse Oct Spinal Fixation SystemMedtronic Sofamor Danek, Inc. · 2006
  6. Descendant · 2 generations on · 150 of its ownK070742 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007
  7. Descendant · 2 generations on · 138 of its ownK091365 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Soafamor Danek · 2009

Showing 5 of 188 descendants. See all descendants

Descendants cleared per year

2005: 22006: 32007: 42008: 52009: 32010: 22011: 52012: 72013: 82014: 112015: 112016: 82017: 122018: 92019: 62020: 172021: 92022: 92023: 192024: 132025: 122026: 13
2005high 19 (2023) · low 2 (2005)2026

Most influential descendants

Showing 5 of 188 · See all
  • K052180Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2005 · cites it directly187descendants
  • K052734Modification to: Vertex Reconstruction SystemMedtronic Sofamor Danek · 2005 · cites it directly175descendants
  • K062879Traverse Oct Spinal Fixation SystemMedtronic Sofamor Danek, Inc. · 2006 · 2 generations on151descendants
  • K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek · 2007 · 2 generations on150descendants
  • K091365Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Soafamor Danek · 2009 · 2 generations on138descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K003780Vertex Reconstruction SystemMedtronic Sofamor Danek, Inc.2001—
0 (this device)K042498Vertex Reconstruction SystemMedtronic Sofamor Danek2004—
+1K052180Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2005—
+1K052734Modification to: Vertex Reconstruction SystemMedtronic Sofamor Danek2005—
+2K062879Traverse Oct Spinal Fixation SystemMedtronic Sofamor Danek, Inc.2006—
+2K070742Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2007—
+2K091365Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Soafamor Danek2009—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200520
200630
200740
200850
200930
201020
201150
201270
201380
2014110
2015110
201680
2017120
201890
201960
2020170
202190
202290
2023190
2024130
2025120
2026130
FIG. 1 — Lineage of K042498, 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? (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
*K003780Vertex Reconstruction System
Summary page 2
…the modified VERTEXTN! Reconstruction System multi axial screws are substantially equivalent to VERTEXTNI Reconstruction System multi axial screws previously cleared in K003780. 00052 DEPART…
Medtronic Sofamor Danek, Inc.2001—

Also cleared against K003780: 20 other devices →

What descends from it? (188)

See all 188

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

NumberDeviceApplicantDecidedDescendants
K052180Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek2005187
K052734Modification to: Vertex Reconstruction SystemMedtronic Sofamor Danek2005175
K062934SierraSeaspine, Inc.200621

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 28, 2011Not classifiedZ-2877-2011OtherScrews are longer then size etched on the screw.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K052180 (Medtronic Sofamor Danek, 2005) has gone furthest, with 187 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.

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 cervical spine and the thoracic spine, (Cl-T3), the VERTEXTM 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. Hooks and Rods The hooks and rods are also intended to provide stabilization to promote…

Read the full statement (132 words)

When intended to promote fusion of the cervical spine and the thoracic spine, (Cl-T3), the VERTEXTM 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.

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 (C 1-T3) spine.

The use of screws (3.5mm and 4.0mm cancellous, and 4.0mm cortical) is limited to placement in TI-T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.

Titanium ATLASTNI Cable used with the VERTEXTM Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.

Indications for use as stated in the FDA summary.

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

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/K042498 · printed Nov 5, 2026

Cite this page

510(k) Report. “K042498: Vertex Reconstruction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042498

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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