510(k) · Cleared
Recalled · 2011CD Horizon Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek USA, Inc. · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Jun 27, 2003 after a 30-day review. The FDA summary names its predicate without a number. 1 of the 1,221 devices in its family, counting itself, has a Class I recall. 1,220 later devices descend from it. It has been recalled once.
- Decided
- Jun 27, 2003
- Review
- 30 days
- Class
- Class II
- Product code
- MNI
- Recalls
- 1
- Predicates
- 0
1,220 later devices descend from it, 25 citing it directly. 1 of the 1,221 devices in this family, counting this one, has a Class I recall.
- This deviceK031655 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2003
- Descendant · cites it directly · 1,130 of its ownK041777 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- Descendant · cites it directly · 1,128 of its ownK043488 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- Descendant · cites it directly · 987 of its ownK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 880 of its ownK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- Descendant · 2 generations on · 870 of its ownK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
Showing 5 of 1,220 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 1,220 · See all- K041777Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004 · cites it directly1,130descendants
- K043488Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005 · cites it directly1,128descendants
- K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · cites it directly987descendants
- K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005 · 2 generations on880descendants
- K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005 · 2 generations on870descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031655 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2003 | — |
| +1 | K041777 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| +1 | K043488 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| +1 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| +2 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| +2 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 7 | 0 |
| 2005 | 12 | 0 |
| 2006 | 10 | 0 |
| 2007 | 11 | 0 |
| 2008 | 11 | 0 |
| 2009 | 22 | 0 |
| 2010 | 23 | 0 |
| 2011 | 31 | 0 |
| 2012 | 53 | 0 |
| 2013 | 62 | 0 |
| 2014 | 60 | 0 |
| 2015 | 65 | 0 |
| 2016 | 64 | 0 |
| 2017 | 71 | 0 |
| 2018 | 73 | 0 |
| 2019 | 67 | 0 |
| 2020 | 74 | 0 |
| 2021 | 68 | 1 |
| 2022 | 81 | 0 |
| 2023 | 102 | 0 |
| 2024 | 86 | 0 |
| 2025 | 86 | 0 |
| 2026 | 81 | 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? (1,220)
See all 1,22025 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041777 | Modification to CD Horizon Spinal System | 2004 | 1,130 |
| K043488 | Modification to CD Horizon Spinal System | 2005 | 1,128 |
| K042025 | Modification to CD Horizon Spinal System | 2004 | 987 |
| K041030 | Modification to CD Horizon Spinal System | 2004 | 790 |
| K052187 | Modification to: CD Horizon Spinal System | 2005 | 780 |
| K042167 | Modification to: CD Horizon Spinal System | 2004 | 658 |
| K091974 | Modification to CD Horizon Spinal System | 2009 | 656 |
| K042790 | CD Horizon Spinal System | 2004 | 546 |
| K142591 | CD HORIZON Spinal System | 2014 | 212 |
| K132471 | CD Horizon Spinal System | 2013 | 132 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 28, 2011 | Not classified | Z-2874-2011 | Other | Screws are longer then size etched on the screw. |
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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K041777 (Medtronic Sofamor Danek, 2004) has gone furthest, with 1,130 descendants of its own.
How does its category compare?
All MNI devicesMNI Orthosis, Spinal Pedicle Fixation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MNI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · MNI
168in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNI
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNI
80in 2025
MAUDE reports naming product code MNI, 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 | 20 | 82 | 26 | 83 |
| 2008 | 23 | 64 | 8 | 108 |
| 2009 | 18 | 86 | 3 | 138 |
| 2010 | 16 | 74 | 1 | 126 |
| 2011 | 17 | 111 | 0 | 146 |
| 2012 | 19 | 75 | 1 | 200 |
| 2013 | 14 | 77 | 4 | 824 |
| 2014 | 6 | 104 | 0 | 301 |
| 2015 | 12 | 54 | 1 | 260 |
| 2016 | 7 | 168 | 0 | 117 |
| 2017 | 1 | — | 0 | 247 |
| 2018 | 0 | — | 1 | 134 |
| 2019 | 0 | — | 0 | 188 |
| 2020 | 0 | — | 0 | 115 |
| 2021 | 0 | — | 0 | 270 |
| 2022 | 0 | — | 0 | 214 |
| 2023 | 0 | — | 0 | 122 |
| 2024 | 0 | — | 0 | 114 |
| 2025 | 0 | — | 0 | 80 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CD HORIZON® system is 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…
Read the full statement (473 words)
The CD HORIZON® system is 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; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) 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.
When used in a percutaneous posterior approach with the SEXTANT instrumentation, the CD HORIZON® Cannulated M8 Multi-Axial Screw components are intended for the following indications:
When used as a pedicle screw fixation system the CD HORIZON® Cannulated M8 Multi-Axial Screw components are 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); (d) who are having the device removed after the development of a solid fusion mass.
In addition, when used as a posterior spine thoracic/lumbar system, the CD HORIZON® Cannulated M8 Multi-Axial Screw components are intended for: (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.
The 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031655 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031655: 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/K031655
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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