510(k) · Cleared
ClearedModification to: CD Horizon (R) Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek USA, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Jun 22, 2010 as substantially equivalent to K981676 (Sofamor Danek USA,Inc., 1999) and 4 other predicates after a 64-day review. Its family tree reaches back 5 generations to 1999. 225 later devices descend from it.
- Decided
- Jun 22, 2010
- Review
- 64 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K981676 (1999). 15 ancestors in all. 225 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK981676 CD Horizon Spinal SystemSofamor Danek USA,Inc. · 1999
- 4 generations backK041862 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 3 generations backK050079 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 2 generations backK050981 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 1 generation backK090390 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- This deviceK101074 Modification to: CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- Descendant · cites it directly · 176 of its ownK132328 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- Descendant · 2 generations on · 85 of its ownK140276 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
- Descendant · 3 generations on · 83 of its ownK142381 Xia 3 Spinal SystemStryker Corp. · 2014
- Descendant · cites it directly · 59 of its ownK140449 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2014
- Descendant · 2 generations on · 58 of its ownK182119 CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2018
Showing 5 of 225 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 225 · See all- K132328CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013 · cites it directly176descendants
- K140276CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014 · 2 generations on85descendants
- K142381Xia 3 Spinal SystemStryker Corp. · 2014 · 3 generations on83descendants
- K140449CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2014 · cites it directly59descendants
- K182119CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2018 · 2 generations on58descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K981676 | CD Horizon Spinal System | Sofamor Danek USA,Inc. | 1999 | — |
| −4 | K041862 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −3 | K050079 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −2 | K050981 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −1 | K090390 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| 0 (this device) | K101074 | Modification to: CD Horizon (R) Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| +1 | K132328 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| +2 | K140276 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2014 | — |
| +3 | K142381 | Xia 3 Spinal System | Stryker Corp. | 2014 | — |
| +1 | K140449 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2014 | — |
| +2 | K182119 | CD HORIZON™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2018 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 10 | 0 |
| 2015 | 15 | 0 |
| 2016 | 11 | 0 |
| 2017 | 12 | 0 |
| 2018 | 15 | 0 |
| 2019 | 8 | 0 |
| 2020 | 24 | 0 |
| 2021 | 12 | 0 |
| 2022 | 12 | 0 |
| 2023 | 27 | 0 |
| 2024 | 28 | 0 |
| 2025 | 19 | 0 |
| 2026 | 29 | 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? (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 |
|---|---|---|---|
| * | K981676 | CD Horizon Spinal SystemSummary page 3…ing that the CD HORIZON® Spinal System is substantially equivalent to other comm~ercially available fixation systems including CD HORIZON® Spinal System in K98 1676 (SE 1/28/99), K040962 (SE 5/14/04), K050981 (SE 5/18/05), K090390 (SE5/15109) and TSRH® Spinal System in K052 144 (… | 1999 |
| * | K040962 | Modification to CD Horizon Spinal SystemSummary page 3…Spinal System is substantially equivalent to other comm~ercially available fixation systems including CD HORIZON® Spinal System in K98 1676 (SE 1/28/99), K040962 (SE 5/14/04), K050981 (SE 5/18/05), K090390 (SE5/15109) and TSRH® Spinal System in K052 144 (SE 9/2/05). V… | 2004 |
| * | K050981 | CD Horizon Spinal SystemSummary page 3…stantially equivalent to other comm~ercially available fixation systems including CD HORIZON® Spinal System in K98 1676 (SE 1/28/99), K040962 (SE 5/14/04), K050981 (SE 5/18/05), K090390 (SE5/15109) and TSRH® Spinal System in K052 144 (SE 9/2/05). VIII. Discussion of the… | 2005 |
| * | K090390 | CD Horizon Spinal SystemSummary page 3…to other comm~ercially available fixation systems including CD HORIZON® Spinal System in K98 1676 (SE 1/28/99), K040962 (SE 5/14/04), K050981 (SE 5/18/05), K090390 (SE5/15109) and TSRH® Spinal System in K052 144 (SE 9/2/05). VIII. Discussion of the Non-Clinical Testing:… | 2009 |
| * | K052144 | TSRH Spinal SystemSummary page 3…ms including CD HORIZON® Spinal System in K98 1676 (SE 1/28/99), K040962 (SE 5/14/04), K050981 (SE 5/18/05), K090390 (SE5/15109) and TSRH® Spinal System in K052 144 (SE 9/2/05). VIII. Discussion of the Non-Clinical Testing: The devices were subjected to axial grip and axi… | 2005 |
What descends from it? (225)
See all 2253 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 11 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 15 ancestors have a recall of any class.
- Of its descendants, K132328 (Medtronic Sofamor Danek USA, Inc., 2013) has gone furthest, with 176 descendants of its own.
- 17 other devices also cite its predicate K981676.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 hack 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 (240 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 hack 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® LEGACYTm 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 CD HORIZON SPIRETM Plate is a posterior, single level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (Ti-SI) as an adjunct to fusion. 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.
In order to achieve additional levels of fixation as an adjunct to fusion, 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/K101074 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101074: Modification to: CD Horizon (R) 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/K101074
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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