510(k) · Cleared
ClearedCD Horizon Anterior Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sofamor Danek USA,Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Nov 27, 1996 after a 76-day review. The FDA summary names no predicate by number. 1 of the 778 devices in its family, counting itself, has a Class I recall. 777 later devices descend from it.
- Decided
- Nov 27, 1996
- Review
- 76 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
777 later devices descend from it, 3 citing it directly. 1 of the 778 devices in this family, counting this one, has a Class I recall.
- This deviceK963655 CD Horizon Anterior Spinal SystemSofamor Danek USA,Inc. · 1996
- Descendant · cites it directly · 776 of its ownK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- Descendant · 2 generations on · 656 of its ownK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 598 of its ownK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- Descendant · 3 generations on · 597 of its ownK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- Descendant · 3 generations on · 597 of its ownK112555 CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
Showing 5 of 777 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 777 · See all- K091442CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009 · cites it directly776descendants
- K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · 2 generations on656descendants
- K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010 · 3 generations on598descendants
- K112473CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011 · 3 generations on597descendants
- K112555CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · 3 generations on597descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K963655 | CD Horizon Anterior Spinal System | Sofamor Danek USA,Inc. | 1996 | — |
| +1 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| +2 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| +3 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| +3 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| +3 | K112555 | CD Horizon (R) Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 5 | 0 |
| 2012 | 15 | 0 |
| 2013 | 25 | 0 |
| 2014 | 34 | 0 |
| 2015 | 37 | 0 |
| 2016 | 40 | 0 |
| 2017 | 46 | 0 |
| 2018 | 51 | 0 |
| 2019 | 43 | 0 |
| 2020 | 55 | 0 |
| 2021 | 56 | 1 |
| 2022 | 68 | 0 |
| 2023 | 85 | 0 |
| 2024 | 77 | 0 |
| 2025 | 70 | 0 |
| 2026 | 65 | 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.
Top candidate predicates for a new KWQ device
- #1 K233640 Segmental Plating System (SPS);IdentiTi SPS…score 21.9 · 31 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
The FDA summary names no predicate by number.
What descends from it? (777)
See all 7773 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K091442 (Medtronic Sofamor Danek, 2009) has gone furthest, with 776 descendants of its own.
How does its category compare?
All KWQ devicesKWQ Appliance, Fixation, Spinal Intervertebral Body: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWQ
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KWQ
64in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWQ
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWQ
248in 2025
MAUDE reports naming product code KWQ, 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 | 27 | 101 | 2 | 288 |
| 2008 | 32 | 70 | 33 | 348 |
| 2009 | 23 | 90 | 35 | 355 |
| 2010 | 23 | 104 | 2 | 691 |
| 2011 | 22 | 95 | 5 | 415 |
| 2012 | 26 | 90 | 7 | 544 |
| 2013 | 22 | 88 | 6 | 796 |
| 2014 | 17 | 124 | 0 | 546 |
| 2015 | 25 | 102 | 2 | 562 |
| 2016 | 15 | 121 | 9 | 502 |
| 2017 | 20 | 67 | 8 | 492 |
| 2018 | 22 | 95 | 1 | 341 |
| 2019 | 26 | 81 | 0 | 298 |
| 2020 | 26 | 55 | 0 | 400 |
| 2021 | 17 | 59 | 0 | 591 |
| 2022 | 18 | 85 | 0 | 392 |
| 2023 | 16 | 59 | 0 | 320 |
| 2024 | 17 | 64 | 0 | 419 |
| 2025 | 7 | 64 | 0 | 248 |
| 2026 | 10 | 76 | 0 | — |
What is it indicated for?
The CD HORIZON™ Anterior Spinal System is designed to aid in the surgical correction and stabilization of the spine. The system is intended to assist stabilization until a solid spinal fusion develops. The specific indications for the CD HORIZON™ Anterior Spinal System are the following: Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies).…
Read the full statement (112 words)
The CD HORIZON™ Anterior Spinal System is designed to aid in the surgical correction and stabilization of the spine. The system is intended to assist stabilization until a solid spinal fusion develops. The specific indications for the CD HORIZON™ Anterior Spinal System are the following:
Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies).
Pseudoarthrosis
Stenosis
Spondylolisthesis
Spinal deformities: scoliosis, kyphosis, lordosis
Fracture
Unsuccessful previous attempts at spinal fusion
Tumor resection
All components of the CD HORIZON™ Anterior Spinal System are intended to be fixed/attached to the anterolateral spine by screws/staples in the thoracic and/or lumbar areas only.
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/K963655 · printed Nov 5, 2026
Cite this page
510(k) Report. “K963655: CD Horizon Anterior Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963655
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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