510(k) Report

510(k) · Cleared

Cleared

Modification to Equation Fixation System

K042453510(k) SpecialCleared Oct 7, 200427-day reviewClass II21 CFR 888.3070

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. · MNI Orthosis, Spinal Pedicle Fixation

Cleared on Oct 7, 2004 as substantially equivalent to K013962 (Medtronic Sofamor Danek, Inc., 2002) after a 27-day review. Its family tree reaches back 1 generation to 2002. 1 of the 900 devices in its family, counting itself, has a Class I recall. 898 later devices descend from it.

Decided
Oct 7, 2004
Review
27 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K013962 (2002). 898 later devices descend from it, 3 citing it directly. 1 of the 900 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2011: 8 descendants cleared2007: 4 descendants cleared2004: 1 descendant cleared2012: 30 descendants cleared2014: 47 descendants cleared2013: 39 descendants cleared2005: 5 descendants cleared2021: 57 descendants cleared, 1 with a Class I recall12016: 49 descendants cleared2008: 7 descendants cleared2006: 5 descendants cleared2009: 9 descendants cleared2019: 45 descendants cleared2010: 3 descendants cleared2017: 50 descendants cleared2024: 78 descendants cleared2020: 63 descendants cleared2015: 45 descendants cleared2026: 67 descendants cleared2023: 88 descendants cleared2022: 69 descendants cleared2018: 55 descendants cleared2025: 74 descendants clearedK013962 · Equation Fixation System · Medtronic Sofamor Danek, Inc. · 2002200020052010201520202025
Descendants, by generation 1 generation forward: 3 descendants2 generations forward: 13 descendants3 generations forward: 48 descendants4 generations forward: 100 descendants5 generations forward: 136 descendants6 generations forward: 186 descendants7 generations forward: 166 descendants8 generations forward: 113 descendants, 1 with a Class I recall19 generations forward: 68 descendants10 generations forward: 49 descendants11 generations forward: 14 descendants12 generations forward: 2 descendants K013962 · Equation Fixation System · Medtronic Sofamor Danek, Inc. · 20020+5+10
  1. Root · 1 generation backK013962 Equation Fixation SystemMedtronic Sofamor Danek, Inc. · 2002
  2. This deviceK042453 Modification to Equation Fixation SystemMedtronic Sofamor Danek, Inc. · 2004
  3. Descendant · cites it directly · 897 of its ownK042962 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
  4. Descendant · 2 generations on · 870 of its ownK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
  5. Descendant · 2 generations on · 821 of its ownK063670 Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2007
  6. Descendant · 3 generations on · 780 of its ownK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
  7. Descendant · 3 generations on · 779 of its ownK082236 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2008

Showing 5 of 898 descendants. See all descendants

Descendants cleared per year

2004: 12005: 52006: 52007: 42008: 72009: 92010: 32011: 82012: 302013: 392014: 472015: 452016: 492017: 502018: 552019: 452020: 632021: 572022: 692023: 882024: 782025: 742026: 67
2004high 88 (2023) · low 1 (2004)2026

Class I recalls in this family

  • K211616 ExcelsiusHub8 generations on · 2021

Most influential descendants

Showing 5 of 898 · See all
  • K042962Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004 · cites it directly897descendants
  • K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005 · 2 generations on870descendants
  • K063670Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2007 · 2 generations on821descendants
  • K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005 · 3 generations on780descendants
  • K082236CD Horizon Spinal SystemMedtronic Sofamor Danek · 2008 · 3 generations on779descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K013962Equation Fixation SystemMedtronic Sofamor Danek, Inc.2002—
0 (this device)K042453Modification to Equation Fixation SystemMedtronic Sofamor Danek, Inc.2004—
+1K042962Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004—
+2K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc.2005—
+2K063670Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek2007—
+3K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek2005—
+3K082236CD Horizon Spinal SystemMedtronic Sofamor Danek2008—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200550
200650
200740
200870
200990
201030
201180
2012300
2013390
2014470
2015450
2016490
2017500
2018550
2019450
2020630
2021571
2022690
2023880
2024780
2025740
2026670
FIG. 1 — Lineage of K042453, 2002–2026Source: 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.

1 device in this family has a Class I recall. 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
*K013962Equation Fixation System
Summary page 2
…M components previously cleared for use in the EQUATION Fixation System (K013962, SE 06/20/02). DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Ser…
Medtronic Sofamor Danek, Inc.2002—

Also cleared against K013962: 3 other devices →

What descends from it? (898)

See all 898

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

NumberDeviceApplicantDecidedDescendants
K042962Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek2004897
K111510CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc.2011128
K072022Valeo Pedicle Screw Spinal SystemAmedica Corp.2007100

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K211616ExcelsiusHubGlobus Medical, Inc. · 2021 · 8 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Its one ancestor has no recall.
  • Of its descendants, K042962 (Medtronic Sofamor Danek, 2004) has gone furthest, with 897 descendants of its own.
  • 3 other devices also cite its predicate K013962.

How does its category compare?

All MNI devices

MNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MNI

1in 2017

2007: 202008: 232009: 182010: 162011: 172012: 192013: 142014: 62015: 122016: 72017: 1
2007high 23 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MNI

168in 2016

2007: 82 days median2008: 64 days median2009: 86 days median2010: 74 days median2011: 111 days median2012: 75 days median2013: 77 days median2014: 104 days median2015: 54 days median2016: 168 days median
2007high 168 (2016) · low 54 (2015)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MNI

1in 2018

2007: 262008: 82009: 32010: 12012: 12013: 42015: 12018: 1
2007high 26 (2007) · low 0 (2011)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MNI

80in 2025

2007: 832008: 1082009: 1382010: 1262011: 1462012: 2002013: 8242014: 3012015: 2602016: 1172017: 2472018: 1342019: 1882020: 1152021: 2702022: 2142023: 1222024: 1142025: 80
2007high 824 (2013) · low 80 (2025)2025

MAUDE reports naming product code MNI, 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
200720822683
200823648108
200918863138
201016741126
2011171110146
201219751200
201314774824
201461040301
201512541260
201671680117
20171—0247
20180—1134
20190—0188
20200—0115
20210—0270
20220—0214
20230—0122
20240—0114
20250—080
20260—0—

What is it indicated for?

The EQUATION TM Fixation System is a temporary implant system used for correction and stabilization of the posterior spine for the development of a solid spinal fusion. When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the EQUATIONT M Fixation System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture…

Read the full statement (165 words)

The EQUATION TM Fixation System is a temporary implant system used for correction and stabilization of the posterior spine for the development of a solid spinal fusion. When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the EQUATIONT M Fixation System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).

In addition, when used as a pedicle screw fixation system, the EQUATION TM Fixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-SI) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

Indications for use as stated in the FDA summary.

Also cleared against K013962

3 other devices cite the same predicate.

  • K162576FORTEZZA Spinal Stabilization SystemOsso Surgical · 2016
  • K152781Adena-Zina SystemShanghai Sanyou Medical Co, Ltd. · 2016
  • K060081Basis Spinal SystemMedtronic Sofamor Danek · 2006

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 MNI

The MNI category page

  • K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co., Ltd. · 2017
  • K160731LumFix Spinal Fixation SytemCG Bio Co., Ltd. · 2016
  • K151458Double Medical Universal Spine SystemDouble Medical Technology, Inc. · 2016
  • K153273MySpine Pedicle Screw Placement Guides - LPMedacta International S.A. · 2016
  • K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpinevision S.A. · 2016

https://510kreport.com/device/K042453 · printed Nov 4, 2026

Cite this page

510(k) Report. “K042453: Modification to Equation Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042453

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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