510(k) · Cleared
ClearedEquation Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek, Inc. · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Jun 20, 2002 after a 199-day review. The FDA summary names its predicate without a number. 1 of the 901 devices in its family, counting itself, has a Class I recall. 900 later devices descend from it.
- Decided
- Jun 20, 2002
- Review
- 199 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 0
900 later devices descend from it, 4 citing it directly. 1 of the 901 devices in this family, counting this one, has a Class I recall.
- This deviceK013962 Equation Fixation SystemMedtronic Sofamor Danek, Inc. · 2002
- Descendant · cites it directly · 898 of its ownK042453 Modification to Equation Fixation SystemMedtronic Sofamor Danek, Inc. · 2004
- Descendant · 2 generations on · 897 of its ownK042962 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- Descendant · 3 generations on · 870 of its ownK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- Descendant · 3 generations on · 821 of its ownK063670 Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2007
- Descendant · 4 generations on · 780 of its ownK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
Showing 5 of 900 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub9 generations on · 2021
Most influential descendants
Showing 5 of 900 · See all- K042453Modification to Equation Fixation SystemMedtronic Sofamor Danek, Inc. · 2004 · cites it directly898descendants
- K042962Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004 · 2 generations on897descendants
- K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005 · 3 generations on870descendants
- K063670Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2007 · 3 generations on821descendants
- K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005 · 4 generations on780descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K013962 | Equation Fixation System | Medtronic Sofamor Danek, Inc. | 2002 | — |
| +1 | K042453 | Modification to Equation Fixation System | Medtronic Sofamor Danek, Inc. | 2004 | — |
| +2 | K042962 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| +3 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| +3 | K063670 | Modifications to CD Horizon Spinal System | Medtronic Sofamor Danek | 2007 | — |
| +4 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 5 | 0 |
| 2006 | 6 | 0 |
| 2007 | 4 | 0 |
| 2008 | 7 | 0 |
| 2009 | 9 | 0 |
| 2010 | 3 | 0 |
| 2011 | 8 | 0 |
| 2012 | 30 | 0 |
| 2013 | 39 | 0 |
| 2014 | 47 | 0 |
| 2015 | 45 | 0 |
| 2016 | 49 | 0 |
| 2017 | 50 | 0 |
| 2018 | 55 | 0 |
| 2019 | 45 | 0 |
| 2020 | 63 | 0 |
| 2021 | 57 | 1 |
| 2022 | 69 | 0 |
| 2023 | 88 | 0 |
| 2024 | 78 | 0 |
| 2025 | 74 | 0 |
| 2026 | 67 | 0 |
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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | CD HORIZON Spinal System Named without a submission number |
What descends from it? (900)
See all 9004 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 9 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K042453 (Medtronic Sofamor Danek, Inc., 2004) has gone furthest, with 898 descendants of its own.
How does its category compare?
All MNH devicesMNH Orthosis, Spondylolisthesis Spinal Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNH
8in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · MNH
93in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNH
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNH
89in 2025
MAUDE reports naming product code MNH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 5 | 123 | 0 | 18 |
| 2008 | 13 | 65 | 0 | 30 |
| 2009 | 13 | 151 | 7 | 45 |
| 2010 | 10 | 106 | 0 | 59 |
| 2011 | 17 | 171 | 0 | 107 |
| 2012 | 7 | 93 | 1 | 433 |
| 2013 | 10 | 124 | 1 | 464 |
| 2014 | 12 | 140 | 0 | 286 |
| 2015 | 10 | 99 | 0 | 152 |
| 2016 | 8 | 93 | 1 | 216 |
| 2017 | 0 | — | 0 | 174 |
| 2018 | 0 | — | 0 | 129 |
| 2019 | 0 | — | 0 | 403 |
| 2020 | 0 | — | 0 | 432 |
| 2021 | 0 | — | 0 | 531 |
| 2022 | 0 | — | 0 | 265 |
| 2023 | 0 | — | 0 | 121 |
| 2024 | 0 | — | 0 | 302 |
| 2025 | 0 | — | 0 | 89 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The EQUATIOWMFixation 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 EQUATIOWMFixation System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3)…
Read the full statement (159 words)
The EQUATIOWMFixation 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 EQUATIOWMFixation 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 EQUATIONTMFixation System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-Sl) 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 ksion mass.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K013962 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013962: Equation Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013962
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026