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. · NQP Posterior Metal/Polymer Spinal System, Fusion
Cleared on Jan 15, 2021 as substantially equivalent to K182928 (Medtronic Sofamor Danek USA, Inc., 2019) and 2 other predicates after a 29-day review. Its family tree reaches back 15 generations to 2004. 35 later devices descend from it.
- Decided
- Jan 15, 2021
- Review
- 29 days
- Class
- Class II
- Product code
- NQP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 15 generations to K040583 (2004). 81 ancestors in all, the oldest K841189 (1984). 35 later devices descend from it, 2 citing it directly.
- Root · 15 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 11 generations between
- 3 generations backK132328 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 2 generations backK182119 CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2018
- 1 generation backK182928 CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2019
- This deviceK203678 CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2021
- Descendant · cites it directly · 34 of its ownK210637 CD Horizon™ Spinal SystemMedtronic · 2021
- Descendant · 2 generations on · 20 of its ownK221244 CD Horizon™ Spinal SystemMedtronic · 2022
- Descendant · 2 generations on · 17 of its ownK223494 CD Horizon Spinal SystemMedtronic · 2023
- Descendant · 2 generations on · 15 of its ownK211958 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2021
- Descendant · 3 generations on · 11 of its ownK223181 NuVasive Reline SystemNu Vasive, Incorporated · 2023
Show all 15 generations
- Root · 15 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 12 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 11 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 10 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 9 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 8 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 7 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 6 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 5 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 4 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 3 generations backK132328 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- 2 generations backK182119 CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2018
- 1 generation backK182928 CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2019
- This deviceK203678 CD HORIZON™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2021
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K210637CD Horizon™ Spinal SystemMedtronic · 2021 · cites it directly34descendants
- K221244CD Horizon™ Spinal SystemMedtronic · 2022 · 2 generations on20descendants
- K223494CD Horizon Spinal SystemMedtronic · 2023 · 2 generations on17descendants
- K211958CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2021 · 2 generations on15descendants
- K223181NuVasive Reline SystemNu Vasive, Incorporated · 2023 · 3 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −14 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −13 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −12 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −11 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −10 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −9 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −8 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −7 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −6 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −5 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −4 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −3 | K132328 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| −2 | K182119 | CD HORIZON™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2018 | — |
| −1 | K182928 | CD Horizon™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2019 | — |
| 0 (this device) | K203678 | CD HORIZON™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| +1 | K210637 | CD Horizon™ Spinal System | Medtronic | 2021 | — |
| +2 | K221244 | CD Horizon™ Spinal System | Medtronic | 2022 | — |
| +2 | K223494 | CD Horizon Spinal System | Medtronic | 2023 | — |
| +2 | K211958 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2021 | — |
| +3 | K223181 | NuVasive Reline System | Nu Vasive, Incorporated | 2023 | — |
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 | 6 | 0 |
| 2004 | 16 | 0 |
| 2005 | 9 | 0 |
| 2006 | 6 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 4 | 0 |
| 2024 | 6 | 0 |
| 2025 | 7 | 0 |
| 2026 | 15 | 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 NQP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K182928 | CD Horizon™ Spinal SystemSummary page 4…0) Subsequent Codes KWP (888.3050), KWQ (888.3060) Predicate 1 (Primary Predicate)- CD HORIZON™ Spinal System- K182928 (S.E. 01/11/2019) Predicate 2: CD HORIZON™ Spinal System – K182119 (S.E. III. Predicate Devices… | 2019 |
| * | K182119 | CD HORIZON™ Spinal SystemSummary page 4…te 1 (Primary Predicate)- CD HORIZON™ Spinal System- K182928 (S.E. 01/11/2019) Predicate 2: CD HORIZON™ Spinal System – K182119 (S.E. III. Predicate Devices 08/29/2018) Predicate 3: CD HORIZON™ Spinal System… | 2018 |
| * | K140449 | CD Horizon Spinal SystemSummary page 4…: CD HORIZON™ Spinal System – K182119 (S.E. III. Predicate Devices 08/29/2018) Predicate 3: CD HORIZON™ Spinal System – K140449 (S.E. 03/25/2014) The subject CD HORIZON™ Spinal System consists of non- IV. De… | 2014 |
What descends from it? (35)
See all 352 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 17 years and passes through 3 companies; a new generation was cleared every 4 months on median.
- 11 of the 81 ancestors have a recall of any class.
- Of its descendants, K210637 (Medtronic, 2021) has gone furthest, with 34 descendants of its own.
- 3 other devices also cite its predicate K182928.
How does its category compare?
All NQP devicesNQP Posterior Metal/Polymer Spinal System, Fusion: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · NQP
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · NQP
70in 2009
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NQP
6in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NQP
8in 2025
MAUDE reports naming product code NQP, 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 | 2 | — | 34 | 45 |
| 2008 | 6 | 156 | 4 | 101 |
| 2009 | 3 | 70 | 6 | 109 |
| 2010 | 2 | — | 0 | 119 |
| 2011 | 0 | — | 0 | 60 |
| 2012 | 0 | — | 6 | 66 |
| 2013 | 0 | — | 0 | 58 |
| 2014 | 1 | — | 0 | 46 |
| 2015 | 0 | — | 0 | 38 |
| 2016 | 0 | — | 0 | 79 |
| 2017 | 0 | — | 0 | 28 |
| 2018 | 0 | — | 0 | 29 |
| 2019 | 2 | — | 0 | 8 |
| 2020 | 0 | — | 0 | 15 |
| 2021 | 1 | — | 0 | 7 |
| 2022 | 0 | — | 0 | 12 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 8 |
| 2026 | 0 | — | 0 | — |
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 (DDD - 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)…
Read the full statement (422 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 (DDD - 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 DDD, 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, pseudarthosis, 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™ PEEK rods are intended to provide posterior supplemental fixation when used with an interbody fusion cage for patients diagnosed with DDD. These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level. This device is intended for 1-2 level use in the lumbosacral spine (L2 – S1) in skeletally mature patients. The device is intended for use with an interbody fusion cage at the instrumented level and is not intended for stand-alone use.
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: DDD (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/K203678 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203678: 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/K203678
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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