510(k) Report

510(k) · Cleared

Cleared

Glaxy 3.2 Spinal System

K043020510(k) TraditionalCleared Jan 7, 200565-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 Jan 7, 2005 as substantially equivalent to K042402 (Medtronic Sofamor Danek, Inc., 2004) after a 65-day review. Its family tree reaches back 2 generations to 2001. 108 later devices descend from it.

Decided
Jan 7, 2005
Review
65 days
Class
Class II
Product code
KWP
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K003780 (2001). 3 ancestors in all. 108 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2007: 1 descendant cleared2011: 1 descendant cleared2013: 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 clearedK003780 · Vertex Reconstruction System · Medtronic Sofamor Danek, Inc. · 2001K042402 · Modification to Vertex Reconstruction System · Medtronic Sofamor Danek, Inc. · 2004200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 1 descendant3 generations forward: 6 descendants4 generations forward: 8 descendants5 generations forward: 16 descendants6 generations forward: 21 descendants7 generations forward: 20 descendants8 generations forward: 14 descendants9 generations forward: 13 descendants10 generations forward: 6 descendants11 generations forward: 2 descendants K042402 · Modification to Vertex Reconstruction System · Medtronic Sofamor Danek, Inc. · 2004K003780 · Vertex Reconstruction System · Medtronic Sofamor Danek, Inc. · 20010+5+10
  1. Root · 2 generations backK003780 Vertex Reconstruction SystemMedtronic Sofamor Danek, Inc. · 2001
  2. 1 generation backK042402 Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek, Inc. · 2004
  3. This deviceK043020 Glaxy 3.2 Spinal SystemMedtronic Sofamor Danek · 2005
  4. Descendant · cites it directly · 107 of its ownK062447 Traverse Oct Spinal Fixation SystemMedtronic Sofamor Danek, Inc. · 2007
  5. Descendant · 2 generations on · 106 of its ownK110522 Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011
  6. Descendant · 3 generations on · 102 of its ownK113593 Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012
  7. Descendant · 4 generations on · 75 of its ownK123549 Polaris Spinal System - Ballista II Percutaneous Screw Placement…Biomet Spine (Aka Ebi, LLC) · 2013 · Recalled
  8. Descendant · 5 generations on · 70 of its ownK131615 Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013

Showing 5 of 108 descendants. See all descendants

Descendants cleared per year

2007: 12011: 12012: 42013: 42014: 82015: 72016: 22017: 82018: 52019: 42020: 132021: 62022: 72023: 92024: 102025: 102026: 9
2007high 13 (2020) · low 0 (2008)2026

Most influential descendants

Showing 5 of 108 · See all
  • K062447Traverse Oct Spinal Fixation SystemMedtronic Sofamor Danek, Inc. · 2007 · cites it directly107descendants
  • K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2011 · 2 generations on106descendants
  • K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC) · 2012 · 3 generations on102descendants
  • K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC) · 2013 · 4 generations on75descendants
  • K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC) · 2013 · 5 generations on70descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K003780Vertex Reconstruction SystemMedtronic Sofamor Danek, Inc.2001—
−1K042402Modification to Vertex Reconstruction SystemMedtronic Sofamor Danek, Inc.2004—
0 (this device)K043020Glaxy 3.2 Spinal SystemMedtronic Sofamor Danek2005—
+1K062447Traverse Oct Spinal Fixation SystemMedtronic Sofamor Danek, Inc.2007—
+2K110522Vertex Reconstruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc.2011—
+3K113593Nextgen Altius Oct SystemBiomet Spine (Aka Ebi, LLC)2012—
+4K123549Polaris Spinal System - Ballista II Percutaneous Screw Placement SystemBiomet Spine (Aka Ebi, LLC)20132
+5K131615Polaris Spinal SystemBiomet Spine (Aka Ebi, LLC)2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
201110
201240
201340
201480
201570
201620
201780
201850
201940
2020130
202160
202270
202390
2024100
2025100
202690
FIG. 1 — Lineage of K043020, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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
*K042402Modification to Vertex Reconstruction System
Summary page 2
…tation was provided which ddmonstrated the GAL.AXYTNI 3.2 Spinal System to be substantially equivalent to VERTEXTm Reconstruction System components previously cleared in K042402. 7X~~~J GO DEPARTMENT OF HE…
Medtronic Sofamor Danek, Inc.2004—

Also cleared against K042402: 3 other devices →

What descends from it? (108)

See all 108

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

NumberDeviceApplicantDecidedDescendants
K062447Traverse Oct Spinal Fixation SystemMedtronic Sofamor Danek, Inc.2007107

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 4 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
  • None of the 3 ancestors has a recall.
  • Of its descendants, K062447 (Medtronic Sofamor Danek, Inc., 2007) has gone furthest, with 107 descendants of its own.
  • 3 other devices also cite its predicate K042402.

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, (CI-T3), the GALAXYTM 3.2 Spinal 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…

Read the full statement (127 words)

When intended to promote fusion of the cervical spine and the thoracic spine, (CI-T3), the GALAXYTM 3.2 Spinal 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 (CI-T3) spine.

Screws/Conntectors

The use of screws is limited to placement in TI-T3 in treating thoracic conditions only. Screws are not intended to be placed in the cervical spine.

Titanium ATLASTM Cable used with the GALAXYTM 3.2 Spinal System allows for cable attachment to the posterior cervical or thoracic spine.

Indications for use as stated in the FDA summary.

Also cleared against K042402

3 other devices cite the same predicate.

  • K082728Vertex Recontruction System, Vertex Select Reconstruction SystemMedtronic Sofamor Danek USA, Inc. · 2009
  • K083071Vertex Reconstruction SystemMedtronic Sofamor Danek · 20081 recall
  • K062934SierraSeaspine, Inc. · 2006

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/K043020 · printed Nov 6, 2026

Cite this page

510(k) Report. “K043020: Glaxy 3.2 Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043020

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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