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, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Mar 25, 2014 as substantially equivalent to K090390 (Medtronic Sofamor Danek, 2009) and 1 other predicate after a 29-day review. Its family tree reaches back 6 generations to 1999. 59 later devices descend from it.
- Decided
- Mar 25, 2014
- Review
- 29 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K981676 (1999). 16 ancestors in all. 59 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK981676 CD Horizon Spinal SystemSofamor Danek USA,Inc. · 1999
- 5 generations backK041862 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 4 generations backK050079 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 3 generations backK050981 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 2 generations backK090390 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 1 generation backK101074 Modification to: CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- This deviceK140449 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2014
- Descendant · cites it directly · 35 of its ownK203678 CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2021
- Descendant · 2 generations on · 34 of its ownK210637 CD Horizon™ Spinal SystemMedtronic · 2021
- Descendant · 3 generations on · 20 of its ownK221244 CD Horizon™ Spinal SystemMedtronic · 2022
- Descendant · 3 generations on · 17 of its ownK223494 CD Horizon Spinal SystemMedtronic · 2023
- Descendant · 3 generations on · 15 of its ownK211958 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2021
Showing 5 of 59 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 59 · See all- K203678CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2021 · cites it directly35descendants
- K210637CD Horizon™ Spinal SystemMedtronic · 2021 · 2 generations on34descendants
- K221244CD Horizon™ Spinal SystemMedtronic · 2022 · 3 generations on20descendants
- K223494CD Horizon Spinal SystemMedtronic · 2023 · 3 generations on17descendants
- K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2021 · 3 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K981676 | CD Horizon Spinal System | Sofamor Danek USA,Inc. | 1999 | — |
| −5 | K041862 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −4 | K050079 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −3 | K050981 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −2 | K090390 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −1 | K101074 | Modification to: CD Horizon (R) Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| 0 (this device) | K140449 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2014 | — |
| +1 | K203678 | CD HORIZON™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| +2 | K210637 | CD Horizon™ Spinal System | Medtronic | 2021 | — |
| +3 | K221244 | CD Horizon™ Spinal System | Medtronic | 2022 | — |
| +3 | K223494 | CD Horizon Spinal System | Medtronic | 2023 | — |
| +3 | K211958 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 1 | 0 |
| 2018 | 5 | 0 |
| 2019 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 11 | 0 |
| 2025 | 9 | 0 |
| 2026 | 16 | 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 NKB? 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 |
|---|---|---|---|
| * | K090390 | CD Horizon Spinal SystemSummary page 3…terials are similar to other legally marketed devices, specifically Medtronic's CD HORIZON® Spinal System. These predicates include CD HORIZON® Spinal System K090390 (S.F. 05/15/2009) and CD HORIZON® Spinal System KIO0 1074 (S.E. 06/22/20 10) IX. SUMMARY OF THE TECHNILOGICAL CHRACTERIST… | 2009 |
| * | K101074 | Modification to: CD Horizon (R) Spinal SystemSummary page 3…erials, and similar design features as the previously FDA cleared predicates; CD HORIZON® Spinal System K090390 (S.E. 05/15/2009) and CD HORIZON® Spinal System K 10 1074 (S.E. 06/22/20 10). Like the predicate CD HORIZON® Spinal System domino connectors, the subject domino connectors are a… | 2010 |
What descends from it? (59)
See all 593 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 15 years and passes through 4 companies; a new generation was cleared every 3.8 years on median.
- 3 of the 16 ancestors have a recall of any class.
- Of its descendants, K203678 (Medtronic Sofamor Danek USA, Inc., 2021) has gone furthest, with 35 descendants of its own.
- 10 other devices also cite its predicate K090390.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 as an adjunct to fusion 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)…
Read the full statement (326 words)
The CD HORIZON® Spinal System with or without SEXTANT® instrumentation is intended for posterior, non-cervical fixation as an adjunct to fusion 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.
Except for hooks, when used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System may also be used for the same indications as an adjunct to fusion.
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 as an adjunct to fusion. The 3.5mm rods may be used for the specific pediatric indications noted below.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the CD HORIZON® Spinal System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis and fracture caused by tumor and/or trauma. These devices are to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD HORIZON® SPIRE™ Plate is a posterior, single level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fixation 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 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/K140449 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140449: 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/K140449
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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