510(k) · Cleared
ClearedCD Horizon Spinal 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 Jul 11, 2000 after an 83-day review. The FDA summary names its predicate without a number. 1 of the 646 devices in its family, counting itself, has a Class I recall. 645 later devices descend from it.
- Decided
- Jul 11, 2000
- Review
- 83 days
- Class
- Class II
- Product code
- MNH
- Recalls
- None
- Predicates
- 0
645 later devices descend from it, 3 citing it directly. 1 of the 646 devices in this family, counting this one, has a Class I recall.
- This deviceK001255 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2000
- Descendant · cites it directly · 595 of its ownK043343 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- Descendant · 2 generations on · 587 of its ownK051674 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- Descendant · 3 generations on · 576 of its ownK063417 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2007
- Descendant · 2 generations on · 528 of its ownK052747 Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- Descendant · 3 generations on · 517 of its ownK102807 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2010
Showing 5 of 645 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub7 generations on · 2021
Most influential descendants
Showing 5 of 645 · See all- K043343Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004 · cites it directly595descendants
- K051674CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005 · 2 generations on587descendants
- K063417Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2007 · 3 generations on576descendants
- K052747Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005 · 2 generations on528descendants
- K102807CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2010 · 3 generations on517descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K001255 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2000 | — |
| +1 | K043343 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| +2 | K051674 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| +3 | K063417 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2007 | — |
| +2 | K052747 | Modification to:CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| +3 | K102807 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 21 | 0 |
| 2013 | 22 | 0 |
| 2014 | 30 | 0 |
| 2015 | 37 | 0 |
| 2016 | 30 | 0 |
| 2017 | 36 | 0 |
| 2018 | 39 | 0 |
| 2019 | 37 | 0 |
| 2020 | 40 | 0 |
| 2021 | 39 | 1 |
| 2022 | 49 | 0 |
| 2023 | 68 | 0 |
| 2024 | 59 | 0 |
| 2025 | 60 | 0 |
| 2026 | 56 | 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? (645)
See all 6453 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 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K043343 (Medtronic Sofamor Danek, 2004) has gone furthest, with 595 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?
When used in a percutaneous posterior approach with the SEXTANT instrumentation, the new CD HORIZON® CANNULATED M8 MULTI-AXTIAL SCREW components are intended for the following indications: When used as a posterior spine thoracic/lumbar system, the CD HORIZON® CANNULATED M8 MULTI-AXIAL SCREW components are intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc…
Read the full statement (481 words)
When used in a percutaneous posterior approach with the SEXTANT instrumentation, the new CD HORIZON® CANNULATED M8 MULTI-AXTIAL SCREW components are intended for the following indications:
When used as a posterior spine thoracic/lumbar system, the CD HORIZON® CANNULATED M8 MULTI-AXIAL SCREW 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., degenerative scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
In addition, when used as a pedicle screw fixation system, the CD HORIZON® CANNULATED M8 MULTI-AXIAL SCREW components are also 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.
The new CD HORIZON® ECLIPSE™ components are intended for the following indications:
When used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System is 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® system is also intended for the following indications:
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the CD HORIZON® Spinal 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 CD HORIZON® Spinal 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.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the CD HORIZON® Spinal System is 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K001255 · printed Nov 6, 2026
Cite this page
510(k) Report. “K001255: CD Horizon 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/K001255
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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