510(k) · Cleared
Recalled · 2011Modification to CD Horizon Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek, Inc. · KWQ Appliance, Fixation, Spinal Intervertebral Body
Cleared on Aug 25, 2004 as substantially equivalent to K040583 (Medtronic Sofamor Danek, 2004) and 8 other predicates after a 28-day review. Its family tree reaches back 2 generations to 2004. 1 of the 997 devices in its family, counting itself, has a Class I recall. 987 later devices descend from it. It has been recalled 4 times.
- Decided
- Aug 25, 2004
- Review
- 28 days
- Class
- Class II
- Product code
- KWQ
- Recalls
- 4
- Predicates
- 9
Its longest line of descent runs back 2 generations to K040583 (2004). 9 ancestors in all, the oldest K981676 (1999). 987 later devices descend from it, 37 citing it directly. 1 of the 997 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 1 generation backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- This deviceK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004
- Descendant · cites it directly · 880 of its ownK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- Descendant · cites it directly · 870 of its ownK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- Descendant · cites it directly · 822 of its ownK060615 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006 · Recalled
- Descendant · cites it directly · 821 of its ownK063670 Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2007
- Descendant · cites it directly · 786 of its ownK052054 TSRH Spinal SystemMedtronic Sofamor Danek · 2005
Showing 5 of 987 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub4 generations on · 2021
Most influential descendants
Showing 5 of 987 · See all- K043151Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005 · cites it directly880descendants
- K050809CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005 · cites it directly870descendants
- K060615CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006 · cites it directly822descendants
- K063670Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2007 · cites it directly821descendants
- K052054TSRH Spinal SystemMedtronic Sofamor Danek · 2005 · cites it directly786descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −1 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| 0 (this device) | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | — |
| +1 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| +1 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| +1 | K060615 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | 34 |
| +1 | K063670 | Modifications to CD Horizon Spinal System | Medtronic Sofamor Danek | 2007 | — |
| +1 | K052054 | TSRH Spinal System | Medtronic Sofamor Danek | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 9 | 0 |
| 2006 | 7 | 0 |
| 2007 | 5 | 0 |
| 2008 | 8 | 0 |
| 2009 | 12 | 0 |
| 2010 | 8 | 0 |
| 2011 | 15 | 0 |
| 2012 | 32 | 0 |
| 2013 | 50 | 0 |
| 2014 | 49 | 0 |
| 2015 | 55 | 0 |
| 2016 | 54 | 0 |
| 2017 | 58 | 0 |
| 2018 | 62 | 0 |
| 2019 | 49 | 0 |
| 2020 | 68 | 0 |
| 2021 | 60 | 1 |
| 2022 | 73 | 0 |
| 2023 | 91 | 0 |
| 2024 | 77 | 0 |
| 2025 | 74 | 0 |
| 2026 | 71 | 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? (9)
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 |
|---|---|---|---|
| * | K040583 | Modification to: CD Horizon Spinal SystemSummary page 2…sly cleared in substantially cquivalcnt to CD HORIZON® Spinal System components K034056, K981676 and KO0l532. K040583, K020709, K031655, K041118, K032265, K000094, ~T… | 2004 |
| * | K020709 | Modification to CD Horizon Spinal SystemSummary page 2…ed in substantially cquivalcnt to CD HORIZON® Spinal System components K034056, K981676 and KO0l532. K040583, K020709, K031655, K041118, K032265, K000094, ~T 7;… | 2002 |
| * | K031655 | CD Horizon Spinal SystemSummary page 2…bstantially cquivalcnt to CD HORIZON® Spinal System components K034056, K981676 and KO0l532. K040583, K020709, K031655, K041118, K032265, K000094, ~T 7; on… | 2003 |
| * | K041118 | Modification to CD Horizon Spinal SystemSummary page 2…ly cquivalcnt to CD HORIZON® Spinal System components K034056, K981676 and KO0l532. K040583, K020709, K031655, K041118, K032265, K000094, ~T 7; onflO?8 ==… | 2004 |
| * | K032265 | CD Horizon Spinal SystemSummary page 2…lcnt to CD HORIZON® Spinal System components K034056, K981676 and KO0l532. K040583, K020709, K031655, K041118, K032265, K000094, ~T 7; onflO?8 === Page 3… | 2003 |
| * | K000094 | Modification to CD Horizon Spinal SystemSummary page 2…D HORIZON® Spinal System components K034056, K981676 and KO0l532. K040583, K020709, K031655, K041118, K032265, K000094, ~T 7; onflO?8… | 2000 |
| * | K034056 | Modification to CD Horizon Spinal SystemSummary page 2…previously cleared in substantially cquivalcnt to CD HORIZON® Spinal System components K034056, K981676 and KO0l532. K040583, K020709, K031655, K041118, K032265, K000094,… | 2004 |
| * | K981676 | CD Horizon Spinal SystemSummary page 2…previously cleared in substantially cquivalcnt to CD HORIZON® Spinal System components K034056, K981676 and KO0l532. K040583, K020709, K031655, K041118, K032265, K000094,… | 1999 |
| * | K001532 | Dyna-Lok Classic Spinal System | 2000 |
What descends from it? (987)
See all 98737 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K043151 | Modification to: CD Horizon Spinal System | 2005 | 880 |
| K050809 | CD Horizon Spinal System | 2005 | 870 |
| K060615 | CD Horizon Spinal System | 2006 | 822 |
| K063670 | Modifications to CD Horizon Spinal System | 2007 | 821 |
| K052054 | TSRH Spinal System | 2005 | 786 |
| K052187 | Modification to: CD Horizon Spinal System | 2005 | 780 |
| K053101 | CD Horizon Spinal System | 2006 | 778 |
| K061591 | Modification to CD Horizon Spinal System | 2006 | 660 |
| K053474 | CD Horizon Spinal System | 2006 | 657 |
| K091974 | Modification to CD Horizon Spinal System | 2009 | 656 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 30, 2011 | Not classified | Z-0464-2012 | Mixed-up of materials/components | One screw may be longer then size etched on the screw. |
| Nov 30, 2011 | Not classified | Z-0465-2012 | Mixed-up of materials/components | One screw may be longer then size etched on the screw. |
| Jun 28, 2011 | Not classified | Z-2878-2011 | Other | Screws are longer then size etched on the screw. |
| Jun 28, 2011 | Not classified | Z-2875-2011 | Other | Screws are longer then size etched on the screw. |
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 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 0 years and passes through 2 companies; a new generation was cleared every 3 months on median.
- 1 of the 9 ancestors has a recall of any class.
- Of its descendants, K043151 (Medtronic Sofamor Danek, 2005) has gone furthest, with 880 descendants of its own.
- 5 other devices also cite its predicate K040583.
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® Spinal System is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion. When used in a…
Read the full statement (305 words)
The CD HORIZON® Spinal System is intended for posterior, non-cervical fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.
When used in a percutaneous, non-cervical, posterior approach with the SEXTANT instrumentation, the CD HORIZON® screws are intended 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 and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, CD 1tORIZONO components such as ECLIPSE® components are 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.
The CD HORIZON® SPIRE Plate is posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (TI - SI). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: 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); and/or tumor.
In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEXTM Reconstruction System with the VERTEXTM rod connector. Refer to the VERTEXTM Reconstruction System Package Insert for a list of the VERTEXTM indications of use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042025 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042025: Modification to 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/K042025
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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