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 · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Nov 18, 2004 as substantially equivalent to K041777 (Medtronic Sofamor Danek, 2004) and 1 other predicate after a 30-day review. Its family tree reaches back 2 generations to 2003. 1 of the 783 devices in its family, counting itself, has a Class I recall. 779 later devices descend from it.
- Decided
- Nov 18, 2004
- Review
- 30 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K031655 (2003). 3 ancestors in all. 779 later devices descend from it, 1 citing it directly. 1 of the 783 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK031655 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2003 · Recalled
- 1 generation backK041777 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- This deviceK042886 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- Descendant · cites it directly · 778 of its ownK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- Descendant · 2 generations on · 776 of its ownK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- Descendant · 3 generations on · 656 of its ownK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- Descendant · 4 generations on · 598 of its ownK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- Descendant · 4 generations on · 597 of its ownK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
Showing 5 of 779 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 779 · See all- K053101CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006 · cites it directly778descendants
- K091442CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009 · 2 generations on776descendants
- K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · 3 generations on656descendants
- K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010 · 4 generations on598descendants
- K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011 · 4 generations on597descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K031655 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2003 | 1 |
| −1 | K041777 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| 0 (this device) | K042886 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| +1 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| +2 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| +3 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| +4 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| +4 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 15 | 0 |
| 2013 | 25 | 0 |
| 2014 | 34 | 0 |
| 2015 | 37 | 0 |
| 2016 | 40 | 0 |
| 2017 | 46 | 0 |
| 2018 | 51 | 0 |
| 2019 | 43 | 0 |
| 2020 | 55 | 0 |
| 2021 | 56 | 1 |
| 2022 | 68 | 0 |
| 2023 | 85 | 0 |
| 2024 | 77 | 0 |
| 2025 | 70 | 0 |
| 2026 | 65 | 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.
Top candidate predicates for a new NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K041777 | Modification to CD Horizon Spinal SystemSummary page 2…antial Equivalence Documentation was provided which demonstrated the CD HORIZON® Spinal System to be substantially equivalent to similar components previously cleared in K04 1777 (SE 09/03/04) and K032265 (SE 8/11/03).… | 2004 |
| * | K032265 | CD Horizon Spinal SystemSummary page 2…ation was provided which demonstrated the CD HORIZON® Spinal System to be substantially equivalent to similar components previously cleared in K04 1777 (SE 09/03/04) and K032265 (SE 8/11/03). ~ z ct… | 2003 |
What descends from it? (779)
See all 7791 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K053101 | CD Horizon Spinal System | 2006 | 778 |
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?
- The line of descent spans 1 year and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K053101 (Medtronic Sofamor Danek, 2006) has gone furthest, with 778 descendants of its own.
- 1 other device also cites its predicate K041777.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
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 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; pseudarthrosis; and/or failed previous fusion. When used in a…
Read the full statement (308 words)
The CD HORIZON® Spinal System 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; 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 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; pseudoarthrosis; 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 - S 1). 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 as back pain of discogenic origin with degeneration of the disc confirmed by 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 VERTEXTM Reconstruction System with the VERTEXTM rod connector. Refer to the VERTEXTM Reconstruction System Package Insert for a list of the VERTEXT M indications of use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042886 · printed Nov 4, 2026
Cite this page
510(k) Report. “K042886: 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/K042886
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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