510(k) · Cleared
ClearedModification to: CD Horizon Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek · MNH Orthosis, Spondylolisthesis Spinal Fixation
Cleared on Dec 28, 2004 as substantially equivalent to K001255 (Medtronic Sofamor Danek, Inc., 2000) and 1 other predicate after a 22-day review. Its family tree reaches back 1 generation to 2000. 1 of the 598 devices in its family, counting itself, has a Class I recall. 595 later devices descend from it.
- Decided
- Dec 28, 2004
- Review
- 22 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K001066 (2000). 2 ancestors in all. 595 later devices descend from it, 3 citing it directly. 1 of the 598 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK001066 CD Horizon EclipseMedtronic Sofamor Danek, Inc. · 2000
- This deviceK043343 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- Descendant · cites it directly · 587 of its ownK051674 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- Descendant · 2 generations on · 576 of its ownK063417 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2007
- Descendant · cites it directly · 528 of its ownK052747 Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- Descendant · 2 generations on · 517 of its ownK102807 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2010
- Descendant · 2 generations on · 357 of its ownK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
Showing 5 of 595 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub6 generations on · 2021
Most influential descendants
Showing 5 of 595 · See all- K051674CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005 · cites it directly587descendants
- K063417Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2007 · 2 generations on576descendants
- K052747Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005 · cites it directly528descendants
- K102807CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2010 · 2 generations on517descendants
- K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012 · 2 generations on357descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001066 | CD Horizon Eclipse | Medtronic Sofamor Danek, Inc. | 2000 | — |
| 0 (this device) | K043343 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| +1 | K051674 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| +2 | K063417 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2007 | — |
| +1 | K052747 | Modification to:CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| +2 | K102807 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2010 | — |
| +2 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 3 | 0 |
| 2012 | 16 | 0 |
| 2013 | 22 | 0 |
| 2014 | 28 | 0 |
| 2015 | 35 | 0 |
| 2016 | 28 | 0 |
| 2017 | 34 | 0 |
| 2018 | 36 | 0 |
| 2019 | 31 | 0 |
| 2020 | 36 | 0 |
| 2021 | 38 | 1 |
| 2022 | 45 | 0 |
| 2023 | 63 | 0 |
| 2024 | 58 | 0 |
| 2025 | 58 | 0 |
| 2026 | 53 | 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? (2)
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 |
|---|---|---|---|
| * | K001255 | CD Horizon Spinal SystemSummary page 2…Documentation was provided which demonstrated the subject instruments to be substantially equivalent to the previously cleared CD HORIZON® SEXTANT instruments cleared in K001255 (SE 07/11/00) for a percutaneous approach cleared in K001066 (SE 06/22/00).… | 2000 |
| * | K001066 | CD Horizon EclipseSummary page 2…truments to be substantially equivalent to the previously cleared CD HORIZON® SEXTANT instruments cleared in K001255 (SE 07/11/00) for a percutaneous approach cleared in K001066 (SE 06/22/00). 00 02i'- === Page… | 2000 |
What descends from it? (595)
See all 5953 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 · 6 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
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 CD HORIZON® Spinal System is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. When…
Read the full statement (305 words)
The CD HORIZON® Spinal System is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
When used in a percutaneous, non-cervical, posterior approach with the SEXTANT instrumentation, the CD HORIZON® screws are intended for the following indications: degenerative disc disease (defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, CD HORIZON® components such as ECLIPSE® components are intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
The CD HORIZON® SPIRE Plate is posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (Ti-Si). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease--defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies; spondylolisthesis; trauma (i.e., fracture or dislocation); and/or tumor.
In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX® Reconstruction System with the VERTEX® rod connector. Refer to the VERTEX® Reconstruction System Package Insert for a list of the VERTEX® indications of use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043343 · printed Nov 4, 2026
Cite this page
510(k) Report. “K043343: Modification to: CD Horizon Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043343
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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