510(k) Report

510(k) · Cleared

Cleared

Modification to Equation Fixation System

K033495510(k) SpecialCleared Dec 3, 200328-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 Dec 3, 2003 after a 28-day review. The FDA summary names its predicate without a number. 101 later devices descend from it.

Decided
Dec 3, 2003
Review
28 days
Class
Class II
Product code
MNI
Recalls
None
Predicates
0

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

Descendants, by year cleared 2007: 1 descendant cleared2021: 7 descendants cleared2012: 4 descendants cleared2014: 6 descendants cleared2013: 3 descendants cleared2016: 6 descendants cleared2008: 2 descendants cleared2017: 3 descendants cleared2024: 12 descendants cleared2020: 13 descendants cleared2026: 11 descendants cleared2019: 4 descendants cleared2023: 12 descendants cleared2009: 1 descendant cleared2015: 3 descendants cleared2022: 5 descendants cleared2018: 3 descendants cleared2025: 5 descendants cleared200020052010201520202025
  1. This deviceK033495 Modification to Equation Fixation SystemMedtronic Sofamor Danek, Inc. · 2003
  2. Descendant · cites it directly · 100 of its ownK072022 Valeo Pedicle Screw Spinal SystemAmedica Corp. · 2007
  3. Descendant · 2 generations on · 43 of its ownK121115 M.U.S.T Pedicle Screw SystemMedacta International · 2012 · Recalled
  4. Descendant · 2 generations on · 30 of its ownK151977 icotec Pedicle SystemIcotec AG · 2016
  5. Descendant · 3 generations on · 29 of its ownK190545 VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2019 · Recalled
  6. Descendant · 2 generations on · 28 of its ownK132878 M.U.S.T. ExtensionMedacta International · 2013

Showing 5 of 101 descendants. See all descendants

Descendants cleared per year

2007: 12008: 22009: 12012: 42013: 32014: 62015: 32016: 62017: 32018: 32019: 42020: 132021: 72022: 52023: 122024: 122025: 52026: 11
2007high 13 (2020) · low 0 (2010)2026

Most influential descendants

Showing 5 of 101 · See all
  • K072022Valeo Pedicle Screw Spinal SystemAmedica Corp. · 2007 · cites it directly100descendants
  • K121115M.U.S.T Pedicle Screw SystemMedacta International · 2012 · 2 generations on43descendants
  • K151977icotec Pedicle SystemIcotec AG · 2016 · 2 generations on30descendants
  • K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG · 2019 · 3 generations on29descendants
  • K132878M.U.S.T. ExtensionMedacta International · 2013 · 2 generations on28descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K033495Modification to Equation Fixation SystemMedtronic Sofamor Danek, Inc.2003—
+1K072022Valeo Pedicle Screw Spinal SystemAmedica Corp.2007—
+2K121115M.U.S.T Pedicle Screw SystemMedacta International20121
+2K151977icotec Pedicle SystemIcotec AG2016—
+3K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG20191
+2K132878M.U.S.T. ExtensionMedacta International2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200820
200910
201240
201330
201460
201530
201660
201730
201830
201940
2020130
202170
202250
2023120
2024120
202550
2026110
FIG. 1 — Lineage of K033495, 2003–2026Source: 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 MNI? 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
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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
*—EQUATION TM1 Fixation System
Named without a submission number
—

What descends from it? (101)

See all 101

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

NumberDeviceApplicantDecidedDescendants
K072022Valeo Pedicle Screw Spinal SystemAmedica Corp.2007100

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, K072022 (Amedica Corp., 2007) has gone furthest, with 100 descendants of its own.

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 EQUATION TM 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 EQUATION TM 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-S1) 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.

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/K033495 · printed Nov 3, 2026

Cite this page

510(k) Report. “K033495: Modification to Equation Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033495

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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