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 USA, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Feb 10, 2016 as substantially equivalent to K152457 (Medtronic Sofamor Danek USA, Inc., 2015) and 5 other predicates after a 56-day review. Its family tree reaches back 14 generations to 2004. 10 later devices descend from it.
- Decided
- Feb 10, 2016
- Review
- 56 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 14 generations to K040583 (2004). 78 ancestors in all, the oldest K841189 (1984). 10 later devices descend from it, 2 citing it directly.
- Root · 14 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 10 generations between
- 3 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 2 generations backK142847 CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc. · 2014
- 1 generation backK152457 CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
- This deviceK153589 CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2016
- Descendant · cites it directly · 6 of its ownK161842 Overwatch Spine SystemAmendia, Inc. · 2016 · Recalled
- Descendant · 2 generations on · 5 of its ownK191576 Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc. · 2019
- Descendant · 3 generations on · 3 of its ownK222516 Mercury® II Spinal SystemSpinal Elements, Inc. · 2022
- Descendant · 4 generations on · 2 of its ownK243916 Primus Spinal Fixation SystemSpinal Elements, Inc. · 2025
- Descendant · cites it directly · 2 of its ownK163301 CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2016
Show all 14 generations
- Root · 14 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 12 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 11 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 10 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 9 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 8 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 7 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 6 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 5 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 4 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 3 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 2 generations backK142847 CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc. · 2014
- 1 generation backK152457 CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2015
- This deviceK153589 CD HORIZON Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2016
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K161842Overwatch Spine SystemAmendia, Inc. · 2016 · cites it directly6descendants
- K191576Mercury® Spinal System, Overwatch® Spinal SystemSpinal Elements, Inc. · 2019 · 2 generations on5descendants
- K222516Mercury® II Spinal SystemSpinal Elements, Inc. · 2022 · 3 generations on3descendants
- K243916Primus Spinal Fixation SystemSpinal Elements, Inc. · 2025 · 4 generations on2descendants
- K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2016 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −13 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −12 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −11 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −10 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −9 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −8 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −7 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −6 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −5 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −4 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −3 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −2 | K142847 | CD HORIZON Spinal System | Medtronic Sofamor Danck USA, Inc. | 2014 | — |
| −1 | K152457 | CD HORIZON Spinal System | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| 0 (this device) | K153589 | CD HORIZON Spinal System | Medtronic Sofamor Danek USA, Inc. | 2016 | — |
| +1 | K161842 | Overwatch Spine System | Amendia, Inc. | 2016 | 1 |
| +2 | K191576 | Mercury® Spinal System, Overwatch® Spinal System | Spinal Elements, Inc. | 2019 | — |
| +3 | K222516 | Mercury® II Spinal System | Spinal Elements, Inc. | 2022 | — |
| +4 | K243916 | Primus Spinal Fixation System | Spinal Elements, Inc. | 2025 | — |
| +1 | K163301 | CD HORIZON® Spinal System | Medtronic Sofamor Danek USA, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 6 | 0 |
| 2002 | 5 | 0 |
| 2003 | 7 | 0 |
| 2004 | 15 | 0 |
| 2005 | 8 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 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? (6)
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 |
|---|---|---|---|
| * | K152457 | CD HORIZON Spinal SystemSummary page 6…age 2 of 5 III. Predicate Devices: CD HORIZON® Spinal System Primary Predicate: K152457 (S.E. 10/27/2015) Additional Predicate K091974 (S.E. 09… | 2015 |
| * | K091974 | Modification to CD Horizon Spinal SystemSummary page 6…Predicate: K152457 (S.E. 10/27/2015) Additional Predicate K091974 (S.E. 09/02/2009) K061579 (S.E. 08/11/2006) K031888 (S.… | 2009 |
| * | K061579 | Modification to CD Horizon Spinal SystemSummary page 6…10/27/2015) Additional Predicate K091974 (S.E. 09/02/2009) K061579 (S.E. 08/11/2006) K031888 (S.E. 06/27/2003) K030840 (S.… | 2006 |
| * | K031888 | Modification to CD Horizon Spinal SystemSummary page 6…dicate K091974 (S.E. 09/02/2009) K061579 (S.E. 08/11/2006) K031888 (S.E. 06/27/2003) K030840 (S.E. 05/15/2003) K020709 (S.… | 2003 |
| * | K030840 | Modification to Horizon Spinal SystemSummary page 6…/2009) K061579 (S.E. 08/11/2006) K031888 (S.E. 06/27/2003) K030840 (S.E. 05/15/2003) K020709 (S.E. 05/09/2002) The predicates have not been subj… | 2003 |
| * | K020709 | Modification to CD Horizon Spinal SystemSummary page 6…/2006) K031888 (S.E. 06/27/2003) K030840 (S.E. 05/15/2003) K020709 (S.E. 05/09/2002) The predicates have not been subject to a design related recall. IV. Description: The… | 2002 |
What descends from it? (10)
2 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 12 years and passes through 4 companies; a new generation was cleared every 4 months on median.
- 11 of the 78 ancestors have a recall of any class.
- Of its descendants, K161842 (Amendia, Inc., 2016) has gone furthest, with 6 descendants of its own.
- 7 other devices also cite its predicate K152457.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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, or lordosis), tumor…
Read the full statement (342 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, 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 progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. 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/K153589 · printed Nov 4, 2026
Cite this page
510(k) Report. “K153589: 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/K153589
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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