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 · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Sep 8, 2004 as substantially equivalent to K041460 (Medtronic Sofamor Danek USA, Inc., 2004) and 1 other predicate after a 28-day review. Its family tree reaches back 2 generations to 2001. 1 of the 662 devices in its family, counting itself, has a Class I recall. 658 later devices descend from it.
- Decided
- Sep 8, 2004
- Review
- 28 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K011508 (2001). 3 ancestors in all. 658 later devices descend from it, 3 citing it directly. 1 of the 662 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK011508 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2001
- 1 generation backK041460 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2004
- This deviceK042167 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- Descendant · cites it directly · 656 of its ownK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 598 of its ownK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- Descendant · 2 generations on · 597 of its ownK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- Descendant · 2 generations on · 597 of its ownK112555 CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
- Descendant · 2 generations on · 596 of its ownK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
Showing 5 of 658 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 658 · See all- K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · cites it directly656descendants
- K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010 · 2 generations on598descendants
- K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011 · 2 generations on597descendants
- K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · 2 generations on597descendants
- K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · 2 generations on596descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K011508 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2001 | — |
| −1 | K041460 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2004 | — |
| 0 (this device) | K042167 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| +1 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| +2 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| +2 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| +2 | K112555 | CD Horizon (R) Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| +2 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 14 | 0 |
| 2013 | 24 | 0 |
| 2014 | 33 | 0 |
| 2015 | 36 | 0 |
| 2016 | 37 | 0 |
| 2017 | 44 | 0 |
| 2018 | 49 | 0 |
| 2019 | 38 | 0 |
| 2020 | 46 | 0 |
| 2021 | 44 | 1 |
| 2022 | 48 | 0 |
| 2023 | 67 | 0 |
| 2024 | 60 | 0 |
| 2025 | 57 | 0 |
| 2026 | 54 | 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 |
|---|---|---|---|
| * | K041460 | CD Horizon Spinal SystemSummary page 2…Documentation was provided which demonstrated the CD HORIZON® Spinal System to be substantially equivalent to CD HORIZON® Spinal System components previously cleared in K041460 and K031655. O0 0002… | 2004 |
| * | K031655 | CD Horizon Spinal SystemSummary page 2…on was provided which demonstrated the CD HORIZON® Spinal System to be substantially equivalent to CD HORIZON® Spinal System components previously cleared in K041460 and K031655. O0 0002 (4 ~DEPARTM… | 2003 |
What descends from it? (658)
See all 6583 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?
- The line of descent spans 3 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K091974 (Medtronic Sofamor Danek USA, Inc., 2009) has gone furthest, with 656 descendants of its own.
- 12 other devices also cite its predicate K041460.
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 (306 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 (T1 - S1). 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 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/K042167 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042167: Modification to: 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/K042167
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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