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 Dec 14, 2004 as substantially equivalent to K042453 (Medtronic Sofamor Danek, Inc., 2004) after a 48-day review. Its family tree reaches back 2 generations to 2002. 1 of the 900 devices in its family, counting itself, has a Class I recall. 897 later devices descend from it.
- Decided
- Dec 14, 2004
- Review
- 48 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K013962 (2002). 897 later devices descend from it, 10 citing it directly. 1 of the 900 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK013962 Equation Fixation SystemMedtronic Sofamor Danek, Inc. · 2002
- 1 generation backK042453 Modification to Equation Fixation SystemMedtronic Sofamor Danek, Inc. · 2004
- This deviceK042962 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- Descendant · cites it directly · 870 of its ownK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- Descendant · cites it directly · 821 of its ownK063670 Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2007
- Descendant · 2 generations on · 780 of its ownK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- Descendant · 2 generations on · 779 of its ownK082236 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2008
- Descendant · 3 generations on · 778 of its ownK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
Showing 5 of 897 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 897 · See all- K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005 · cites it directly870descendants
- K063670Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2007 · cites it directly821descendants
- K052187Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005 · 2 generations on780descendants
- K082236CD Horizon Spinal SystemMedtronic Sofamor Danek · 2008 · 2 generations on779descendants
- K053101CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006 · 3 generations on778descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K013962 | Equation Fixation System | Medtronic Sofamor Danek, Inc. | 2002 | — |
| −1 | K042453 | Modification to Equation Fixation System | Medtronic Sofamor Danek, Inc. | 2004 | — |
| 0 (this device) | K042962 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| +1 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| +1 | K063670 | Modifications to CD Horizon Spinal System | Medtronic Sofamor Danek | 2007 | — |
| +2 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| +2 | K082236 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2008 | — |
| +3 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 5 | 0 |
| 2006 | 5 | 0 |
| 2007 | 4 | 0 |
| 2008 | 7 | 0 |
| 2009 | 9 | 0 |
| 2010 | 3 | 0 |
| 2011 | 8 | 0 |
| 2012 | 30 | 0 |
| 2013 | 39 | 0 |
| 2014 | 47 | 0 |
| 2015 | 45 | 0 |
| 2016 | 49 | 0 |
| 2017 | 50 | 0 |
| 2018 | 55 | 0 |
| 2019 | 45 | 0 |
| 2020 | 63 | 0 |
| 2021 | 57 | 1 |
| 2022 | 69 | 0 |
| 2023 | 88 | 0 |
| 2024 | 78 | 0 |
| 2025 | 74 | 0 |
| 2026 | 67 | 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? (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 |
|---|---|---|---|
| * | K042453 | Modification to Equation Fixation SystemSummary page 2…valence Documentation was provided which demonstrated the subject components to be substantially equivalent to the previously cleared EQUATION Tm Fixation System device (K042453) for use for identical indications.… | 2004 |
What descends from it? (897)
See all 89710 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K050809 | CD Horizon Spinal System | 2005 | 870 |
| K063670 | Modifications to CD Horizon Spinal System | 2007 | 821 |
| K111510 | CD Horizon Spinal System | 2011 | 128 |
| K072022 | Valeo Pedicle Screw Spinal System | 2007 | 100 |
| K121764 | CD Horizon Spinal System | 2012 | 45 |
| K121115 | M.U.S.T Pedicle Screw System | 2012 | 43 |
| K132878 | M.U.S.T. Extension | 2013 | 28 |
| K141044 | M.U.S.T. Extension | 2014 | 16 |
| K113625 | DSS Stabilization System | 2012 | 1 |
| K120491 | DSS Stabilization System-Rigid | 2012 | 0 |
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?
- The line of descent spans 2 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K050809 (Medtronic Sofamor Danek USA, Inc., 2005) has gone furthest, with 870 descendants of its own.
- 2 other devices also cite its predicate K042453.
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 (453 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 - SI). 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.
The CD HORIZON® LEGACY 3.5amm rod and associated components, when used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, are 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® LEGACY 3.5Srm rod and associated 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); and (d) who are having the device removed after the development of a solid fusion mass.
In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX TM 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/K042962 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042962: Modification to 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/K042962
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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