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 · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Aug 11, 2003 after a 19-day review. The FDA summary names no predicate by number. 1 of the 1,193 devices in its family, counting itself, has a Class I recall. 1,192 later devices descend from it.
- Decided
- Aug 11, 2003
- Review
- 19 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- None
- Predicates
- 0
1,192 later devices descend from it, 10 citing it directly. 1 of the 1,193 devices in this family, counting this one, has a Class I recall.
- This deviceK032265 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2003
- Descendant · cites it directly · 1,130 of its ownK041777 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- Descendant · 2 generations on · 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 · 2 generations on · 870 of its ownK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
Showing 5 of 1,192 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 1,192 · See all- K041777Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004 · cites it directly1,130descendants
- K043488Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005 · 2 generations on1,128descendants
- 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
- 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) | K032265 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2003 | — |
| +1 | K041777 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| +2 | 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 | — |
| +2 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 5 | 0 |
| 2005 | 11 | 0 |
| 2006 | 11 | 0 |
| 2007 | 14 | 0 |
| 2008 | 12 | 0 |
| 2009 | 22 | 0 |
| 2010 | 24 | 0 |
| 2011 | 30 | 0 |
| 2012 | 53 | 0 |
| 2013 | 58 | 0 |
| 2014 | 59 | 0 |
| 2015 | 66 | 0 |
| 2016 | 65 | 0 |
| 2017 | 71 | 0 |
| 2018 | 71 | 0 |
| 2019 | 65 | 0 |
| 2020 | 69 | 0 |
| 2021 | 65 | 1 |
| 2022 | 79 | 0 |
| 2023 | 99 | 0 |
| 2024 | 85 | 0 |
| 2025 | 81 | 0 |
| 2026 | 77 | 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? (1,192)
See all 1,19210 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K041777 | Modification to CD Horizon Spinal System | 2004 | 1,130 |
| K042025 | Modification to CD Horizon Spinal System | 2004 | 987 |
| K042886 | CD Horizon Spinal System | 2004 | 779 |
| K091974 | Modification to CD Horizon Spinal System | 2009 | 656 |
| K042790 | CD Horizon Spinal System | 2004 | 546 |
| K041801 | Expedium Mis Spine System | 2004 | 533 |
| K100605 | Mis System | 2010 | 33 |
| K143141 | CD HORIZON Spinal System | 2014 | 16 |
| K123487 | Gso GS1 Cannulated Screw System | 2013 | 0 |
| K071074 | Mykres Spinal System | 2008 | 0 |
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, K041777 (Medtronic Sofamor Danek, 2004) has gone furthest, with 1,130 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@system is intended for the following indications: When used as a pedicle screw fixation system of the noncenical 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, andor (7) failed previous fusion…
Read the full statement (656 words)
The CD HORIZON@system is intended for the following indications:
When used as a pedicle screw fixation system of the noncenical 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, andor (7) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the CD HORIZON@ Spinal System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S 1) vertebral joint; @) who are receiving fusions using autogenous bone graft only; (3) 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, noncervical, 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, andor lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, andor (8) failed previous fusion.
When used in a percutaneous posterior approach with the SEXTANT instrumentation, the CD HORIZON@ Cannulated M8 Multi-Axial Screw components are intended for the following indications:
When used as a pedicle screw fixation system the CD HORIZON0 Cannulated M8 Multi-Axial Screw components are indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S 1) 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); (d) who are having the device removed after the development of a solid fusion mass.
In addition, when used as a posterior spine thoracicAumbar system, the CD HORIZON@ Cannulated M8 Multi-Axial Screw components are intended for: (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. degenerative scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, andor (8) failed previous fusion.
The CD HORIZON0 ECLIPSE0 components are intended for the following indications:
When used as an anterolateral thoracichmbar system, the CD HORIZON0 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 (Le., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, andor (8) failed previous fusion.
In order to achieve additional levels of fixation, the CD HORIZON@ Spinal System rods may be connected to the VERTEXTM Reconstruction System with the V E R T E F rod copnector. When connecting to the VERTEXm Reconstruction System in the cervical spine, components are intended for the following indications:
When intended to promote fusion of the cervical spine and the thoracic spine, (Cl-T3), the VERTEXm Reconstruction System is indicated for the following:
DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors.
Hooks and Rods
The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervicaVupper thoracic (C1-T3) spine.
Multi-axial ScrewsLateral Connectors
The use of VERTEXTMrxulti-axial screws (3.5~ and 4.0mm cancellous, and 4.0mm cortical) is limited to placement in Tl-T3 in treating thoracic conditions only. The multi-axial screws are not intended to be placed in the cervical spine.
Titanium ATLASm Cable and the CD HORIZON@ Spinal System may be used with the VERTEXTMReconstruction System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032265 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032265: 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/K032265
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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