510(k) · Cleared
ClearedModifications 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 Jun 28, 2007 as substantially equivalent to K042962 (Medtronic Sofamor Danek, 2004) and 4 other predicates after a 199-day review. Its family tree reaches back 5 generations to 2004. 1 of the 853 devices in its family, counting itself, has a Class I recall. 821 later devices descend from it.
- Decided
- Jun 28, 2007
- Review
- 199 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K040583 (2004). 31 ancestors in all, the oldest K841189 (1984). 821 later devices descend from it, 9 citing it directly. 1 of the 853 devices in this family, counting this one, has a Class I recall.
- Root · 5 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 4 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 3 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 2 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 1 generation backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- This deviceK063670 Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2007
- Descendant · cites it directly · 779 of its ownK082236 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2008
- Descendant · 2 generations on · 776 of its ownK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- Descendant · 2 generations on · 656 of its ownK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 598 of its ownK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- Descendant · 3 generations on · 597 of its ownK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
Showing 5 of 821 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 821 · See all- K082236CD Horizon Spinal SystemMedtronic Sofamor Danek · 2008 · cites it directly779descendants
- K091442CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009 · 2 generations on776descendants
- K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · 2 generations on656descendants
- K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010 · 3 generations on598descendants
- K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011 · 3 generations on597descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −4 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −3 | 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 | — |
| −1 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| 0 (this device) | K063670 | Modifications to CD Horizon Spinal System | Medtronic Sofamor Danek | 2007 | — |
| +1 | K082236 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2008 | — |
| +2 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| +2 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| +3 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| +3 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
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 | 7 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 4 | 0 |
| 2009 | 7 | 0 |
| 2010 | 3 | 0 |
| 2011 | 6 | 0 |
| 2012 | 21 | 0 |
| 2013 | 33 | 0 |
| 2014 | 37 | 0 |
| 2015 | 40 | 0 |
| 2016 | 42 | 0 |
| 2017 | 46 | 0 |
| 2018 | 54 | 0 |
| 2019 | 44 | 0 |
| 2020 | 60 | 0 |
| 2021 | 56 | 1 |
| 2022 | 69 | 0 |
| 2023 | 86 | 0 |
| 2024 | 77 | 0 |
| 2025 | 71 | 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? (5)
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 |
|---|---|---|---|
| * | K042962 | Modification to CD Horizon Spinal SystemSummary page 2…ion, including a risk analysis, was provided which demonstrated the subject rods to be substantially equivalent to predicate CD HORIZON® components previously cleared in K042962, K050809, K032033, K042025 and K060615. Pal- Z6 DEPARTMENT OF HEALTH &HUMAN SERV… | 2004 |
| * | K050809 | CD Horizon Spinal SystemSummary page 2…uding a risk analysis, was provided which demonstrated the subject rods to be substantially equivalent to predicate CD HORIZON® components previously cleared in K042962, K050809, K032033, K042025 and K060615. Pal- Z6 DEPARTMENT OF HEALTH &HUMAN SERVICES… | 2005 |
| * | K032033 | CD Horizon Spinal SystemSummary page 2…isk analysis, was provided which demonstrated the subject rods to be substantially equivalent to predicate CD HORIZON® components previously cleared in K042962, K050809, K032033, K042025 and K060615. Pal- Z6 DEPARTMENT OF HEALTH &HUMAN SERVICES… | 2003 |
| * | K042025 | Modification to CD Horizon Spinal SystemSummary page 2…sis, was provided which demonstrated the subject rods to be substantially equivalent to predicate CD HORIZON® components previously cleared in K042962, K050809, K032033, K042025 and K060615. Pal- Z6 DEPARTMENT OF HEALTH &HUMAN SERVICES… | 2004 |
| * | K060615 | CD Horizon Spinal SystemSummary page 2…vided which demonstrated the subject rods to be substantially equivalent to predicate CD HORIZON® components previously cleared in K042962, K050809, K032033, K042025 and K060615. Pal- Z6 DEPARTMENT OF HEALTH &HUMAN SERVICES… | 2006 |
What descends from it? (821)
See all 8219 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K082236 | CD Horizon Spinal System | 2008 | 779 |
| K073562 | Modification to Viper Spine System | 2008 | 213 |
| K082353 | Mercury Spinal System | 2009 | 11 |
| K083230 | Mercury Spinal System | 2008 | 11 |
| K081978 | Reliance Spinal Screw System | 2009 | 8 |
| K101112 | Reliance Spinal Screw System | 2010 | 7 |
| K110896 | Reliance Spinal Screw System | 2012 | 5 |
| K083825 | Eoi Spinal System | 2009 | 0 |
| K073143 | Modified Vertiflex Spinal Screw System | 2008 | 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 · 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 4 months on median.
- 5 of the 31 ancestors have a recall of any class.
- Of its descendants, K082236 (Medtronic Sofamor Danek, 2008) has gone furthest, with 779 descendants of its own.
- 9 other devices also cite its predicate K042962.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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 with or without SEXTANT® 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 (330 words)
The CD HORIZON® Spinal System with or without SEXTANT® 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.
When used as a pedicle screw fixation system in skeletally mature patients, the CD HORIZON® AGILE TM Dynamic Stabilization device is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the degenerative spondylolisthesis with objective evidence of neurologic impairment and/or failed previous fusion in the thoracic, lumbar and/or sacral spine. Additionally, when used as a pedicle screw fixation system, the CD HORIZON® AGILEM Dynamic Stabilization device is indicated for use in patients who are receiving fusions with autogenous graft only; who are having the device fixed or attached to the lumbar or sacral spine; and/or 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 VERTEXTM 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/K063670 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063670: Modifications to 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/K063670
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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