510(k) Report

510(k) · Cleared

Cleared

Modification to Vertex Reconstruction System

K022015510(k) SpecialCleared Jul 18, 200228-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, Inc. · KWP Appliance, Fixation, Spinal Interlaminal

Cleared on Jul 18, 2002 after a 28-day review. The FDA summary names no predicate by number. 22 later devices descend from it.

Decided
Jul 18, 2002
Review
28 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
0

22 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2006: 1 descendant cleared2008: 2 descendants cleared2014: 2 descendants cleared2012: 2 descendants cleared2011: 1 descendant cleared2023: 3 descendants cleared2020: 1 descendant cleared2013: 2 descendants cleared2016: 2 descendants cleared2018: 2 descendants cleared2015: 2 descendants cleared2021: 1 descendant cleared2022: 1 descendant cleared200020052010201520202025
  1. This deviceK022015 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek, Inc. · 2002
  2. Descendant · cites it directly · 21 of its ownK062934 SierraSeaspine, Inc. · 2006
  3. Descendant · 2 generations on · 9 of its ownK080526 Sierra SystemSeaspine, Inc. · 2008
  4. Descendant · 2 generations on · 6 of its ownK133698 Synapse SystemSynthes USA Products, LLC · 2014
  5. Descendant · 3 generations on · 5 of its ownK141897 Synapse System, Synthes OC Fusion SystemSynthes USA Products, LLC · 2014
  6. Descendant · 2 generations on · 5 of its ownK072729 SierraSeaspine, Inc. · 2008

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2006: 12008: 22011: 12012: 22013: 22014: 22015: 22016: 22018: 22020: 12021: 12022: 12023: 3
2006high 3 (2023) · low 0 (2007)2026

Most influential descendants

Showing 5 of 22 · See all
  • K062934SierraSeaspine, Inc. · 2006 · cites it directly21descendants
  • K080526Sierra SystemSeaspine, Inc. · 2008 · 2 generations on9descendants
  • K133698Synapse SystemSynthes USA Products, LLC · 2014 · 2 generations on6descendants
  • K141897Synapse System, Synthes OC Fusion SystemSynthes USA Products, LLC · 2014 · 3 generations on5descendants
  • K072729SierraSeaspine, Inc. · 2008 · 2 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K022015Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek, Inc.2002—
+1K062934SierraSeaspine, Inc.2006—
+2K080526Sierra SystemSeaspine, Inc.2008—
+2K133698Synapse SystemSynthes USA Products, LLC2014—
+3K141897Synapse System, Synthes OC Fusion SystemSynthes USA Products, LLC2014—
+2K072729SierraSeaspine, Inc.2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200820
201110
201220
201320
201420
201520
201620
201820
202010
202110
202210
202330
FIG. 1 — Lineage of K022015, 2002–2023Source: 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?

The FDA summary names no predicate by number.

What descends from it? (22)

See all 22

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

NumberDeviceApplicantDecidedDescendants
K062934SierraSeaspine, Inc.200621

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, K062934 (Seaspine, Inc., 2006) has gone furthest, with 21 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.

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, (C1-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 andor tumors. Hooks and Rods The hooks and rods are also intended to provide stabilization to promote fusion…

Read the full statement (133 words)

When intended to promote fusion of the cervical spine and the thoracic spine, (C1-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 andor 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 cervicalhpper thoracic (C1-T3) spine.

ScrewdConnectors

The use of screws (3.5mm and 4.0mm cancellous, and 4.0mm cortical) is limited to placement in T1 T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.

Titanium ATLAST™ Cable used with the VERTEX™ Reconstruction System allows for cable attachment to the posterior cervical or thoracic spine.

Indications for use as stated in the FDA summary.

More from Medtronic Sofamor Danek, Inc.

125 FDA decisions under this applicant name. See the company

  • K251193Grafton™ DBM; Grafton Plus™ DBM Paste; Magnifuse™ Bone GraftMedtronic Sofamor Danek, Inc. · 2025
  • K243706Mastergraft Matrix EXT; Mastergraft Strip; Mastergraft Putty; Mastergraft GranulesMedtronic Sofamor Danek, Inc. · 2025
  • K230716Robotic Graft Delivery InstrumentsMedtronic Sofamor Danek, Inc. · 2023
  • P060018/S005Prestige Cervical Disc SystemMedtronic Sofamor Danek, Inc. · 2016
  • P060018/S004PRESTIGE® Cervical DiscMedtronic Sofamor Danek, Inc. · 2016

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/K022015 · printed Nov 3, 2026

Cite this page

510(k) Report. “K022015: Modification to Vertex Reconstruction System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K022015

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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