510(k) · Cleared
ClearedCD Horizon Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sofamor Danek USA,Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Jan 28, 1999 after a 261-day review. The FDA summary names no predicate by number. 1 of the 1,219 devices in its family, counting itself, has a Class I recall. 1,218 later devices descend from it.
- Decided
- Jan 28, 1999
- Review
- 261 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 0
1,218 later devices descend from it, 18 citing it directly. 1 of the 1,219 devices in this family, counting this one, has a Class I recall.
- This deviceK981676 CD Horizon Spinal SystemSofamor Danek USA,Inc. · 1999
- Descendant · cites it directly · 1,128 of its ownK043488 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- Descendant · cites it directly · 987 of its ownK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 880 of its ownK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- Descendant · cites it directly · 880 of its ownK041862 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- Descendant · 2 generations on · 870 of its ownK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
Showing 5 of 1,218 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 1,218 · See all- K043488Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005 · cites it directly1,128descendants
- K042025Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · cites it directly987descendants
- K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005 · 2 generations on880descendants
- K041862CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004 · cites it directly880descendants
- K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005 · 2 generations on870descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981676 | CD Horizon Spinal System | Sofamor Danek USA,Inc. | 1999 | — |
| +1 | K043488 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| +1 | 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 | K041862 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| +2 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 5 | 0 |
| 2005 | 15 | 0 |
| 2006 | 10 | 0 |
| 2007 | 11 | 0 |
| 2008 | 15 | 0 |
| 2009 | 22 | 0 |
| 2010 | 21 | 0 |
| 2011 | 30 | 0 |
| 2012 | 52 | 0 |
| 2013 | 58 | 0 |
| 2014 | 62 | 0 |
| 2015 | 64 | 0 |
| 2016 | 65 | 0 |
| 2017 | 77 | 0 |
| 2018 | 76 | 0 |
| 2019 | 67 | 0 |
| 2020 | 73 | 0 |
| 2021 | 66 | 1 |
| 2022 | 80 | 0 |
| 2023 | 100 | 0 |
| 2024 | 86 | 0 |
| 2025 | 82 | 0 |
| 2026 | 78 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (1,218)
See all 1,21818 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043488 | Modification to CD Horizon Spinal System | 2005 | 1,128 |
| K042025 | Modification to CD Horizon Spinal System | 2004 | 987 |
| K041862 | CD Horizon Spinal System | 2004 | 880 |
| K041030 | Modification to CD Horizon Spinal System | 2004 | 790 |
| K090390 | CD Horizon Spinal System | 2009 | 663 |
| K013885 | Blackstone Spinal Fixation System Posterior Hooks | 2002 | 300 |
| K101074 | Modification to: CD Horizon (R) Spinal System | 2010 | 225 |
| K132328 | CD Horizon Spinal System | 2013 | 176 |
| K111510 | CD Horizon Spinal System | 2011 | 128 |
| K121764 | CD Horizon Spinal System | 2012 | 45 |
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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K043488 (Medtronic Sofamor Danek, 2005) has gone furthest, with 1,128 descendants of its own.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, 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 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the CD HORIZON® Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation…
Read the full statement (276 words)
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the CD HORIZON® Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the CD HORIZON® Spinal System is also indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed after the development of a solid fusion mass.
When used as a posterior, non-cervical, non-pedicle screw fixation system, the CD HORIZON® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
When used as an anterolateral thoracic/lumbar system, the CD HORIZON® Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K981676 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981676: 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/K981676
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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