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 · MNI Orthosis, Spinal Pedicle Fixation
Cleared on Sep 25, 2006 as substantially equivalent to K053101 (Medtronic Sofamor Danek, 2006) after a 20-day review. Its family tree reaches back 7 generations to 2004. 2 later devices descend from it.
- Decided
- Sep 25, 2006
- Review
- 20 days
- Class
- Class II
- Product code
- MNI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K040583 (2004). 34 ancestors in all, the oldest K841189 (1984). 2 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 6 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 5 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 4 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 3 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 2 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 1 generation backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- This deviceK062606 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- Descendant · cites it directly · 1 of its ownK173249 CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2018
- Descendant · 2 generations on · 0 of its ownK253335 CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −6 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −5 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −4 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −3 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −2 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −1 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| 0 (this device) | K062606 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| +1 | K173249 | CD HORIZON™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2018 | — |
| +2 | K253335 | CD Horizon™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 4 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 8 | 0 |
| 2005 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2025 | 1 | 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.
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
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 |
|---|---|---|---|
| * | K053101 | CD Horizon Spinal SystemSummary page 2…subject CD HORIZON® ENGAGE Plate Threaded Nut Cap to be substantially equivalent to the non-sterile version cleared in an earlier CD HORIZON® Spinal System application - K053101 (SE 01/05/06). The labeling is identical to that of the CD HORIZON® Spinal System cleared in K061304 (SE 07/18/06). === Page 3 =… | 2006 |
| † | K061304 | CD Horizon Spinal System | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173249 | CD HORIZON™ Spinal System | 2018 | 1 |
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?
- The line of descent spans 2 years and passes through 3 companies; a new generation was cleared every 4 months on median.
- 3 of the 34 ancestors have a recall of any class.
- Of its descendants, K173249 (Medtronic Sofamor Danek USA, Inc., 2018) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K053101.
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® Spinal System with or without SEXTENT® instrumentation is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthritis…
Read the full statement (213 words)
The CD HORIZON® Spinal System with or without SEXTENT® instrumentation is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthritis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications.
With the exception of degenerative disc disease, the CD HORIZON LEGACY 3.5mm rods and the CD HORIZON® Spinal System PEEK rods and associated components may be used for the aforementioned indications in skeletally mature patients.
The CD HORIZON® SPIRE Plate is a 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 processes for the purpose of achieving supplemental fusion in the following conditions: degenerative disc disease (as previously defined); spondylolisthesis, trauma; and/or tumor.
In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEXTN( Reconstruction System with the VERTEXTM rod connector. Refer to the VERTEXTM Reconstruction System Package Insert for a list of the VERTEXTM indications of use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062606 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062606: CD Horizon Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062606
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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