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, Inc. · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Jan 26, 2011 as substantially equivalent to K090252 (Lanx, Inc., 2009) and 2 other predicates after a 118-day review. Its family tree reaches back 4 generations to 2004. 2 later devices descend from it.
- Decided
- Jan 26, 2011
- Review
- 118 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K033826 (2004). 8 ancestors in all, the oldest K032037 (2003). 2 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK033826 Orthopedic Alliance Spine SystemOrthopedic Alliance, LLC · 2004 · Recalled
- 3 generations backK043484 Lanx Spinal Fixation SystemLanx, LLC · 2005
- 2 generations backK071633 Lanx Deformity SystemLanx, LLC · 2007
- 1 generation backK090252 Modification to: Lanx Spinal Fixation SystemLanx, Inc. · 2009
- This deviceK102886 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- Descendant · cites it directly · 1 of its ownK123232 Spineology Spinous Process PlateSpineology, Inc. · 2013
- Descendant · 2 generations on · 0 of its ownK142213 Via Spinous Process Fixation SystemSpineology, Inc. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K033826 | Orthopedic Alliance Spine System | Orthopedic Alliance, LLC | 2004 | 1 |
| −3 | K043484 | Lanx Spinal Fixation System | Lanx, LLC | 2005 | — |
| −2 | K071633 | Lanx Deformity System | Lanx, LLC | 2007 | — |
| −1 | K090252 | Modification to: Lanx Spinal Fixation System | Lanx, Inc. | 2009 | — |
| 0 (this device) | K102886 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| +1 | K123232 | Spineology Spinous Process Plate | Spineology, Inc. | 2013 | — |
| +2 | K142213 | Via Spinous Process Fixation System | Spineology, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 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 KWP? 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 |
|---|---|---|---|
| * | K090252 | Modification to: Lanx Spinal Fixation SystemSummary page 3…features, material and indications for use of the CD HORIZON®D SPIRETM Plate are substantially equivalent to the LANX ASPEN Interspinous Anchor cleared in K090252 (SE 03/04/09) and K071877 (SE 09/17/07) as well as the NuVasive AFFIX device cleared in K073278 (SE 03/28/08). === Page 4… | 2009 |
| * | K071877 | Lanx Spinal Fixation SystemSummary page 3…dications for use of the CD HORIZON®D SPIRETM Plate are substantially equivalent to the LANX ASPEN Interspinous Anchor cleared in K090252 (SE 03/04/09) and K071877 (SE 09/17/07) as well as the NuVasive AFFIX device cleared in K073278 (SE 03/28/08). DEPARTMENT OF H… | 2007 |
| * | K073278 | Spinous Process Plate SystemSummary page 3…equivalent to the LANX ASPEN Interspinous Anchor cleared in K090252 (SE 03/04/09) and K071877 (SE 09/17/07) as well as the NuVasive AFFIX device cleared in K073278 (SE 03/28/08). DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Se… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123232 | Spineology Spinous Process Plate | 2013 | 1 |
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 7 years and passes through 4 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 8 ancestors has a recall of any class.
- Of its descendants, K123232 (Spineology, Inc., 2013) has gone furthest, with 1 descendant of its own.
- 7 other devices also cite its predicate K090252.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
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?
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 (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, kcyphosis and/or lordosis)…
Read the full statement (305 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 (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, kcyphosis and/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 degenerative disc disease, the CD HORIZON®D LEGACYIM 3.5mmn 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 3.5mmn 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 adolescent idiopathic scoliosis. The CD HORIZON® Pediatric Spinal System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The CD HORIZON SPIREIM Plate is a posterior, single level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (TI-SI) 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: degenerative disc disease (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/K102886 · printed Nov 5, 2026
Cite this page
510(k) Report. “K102886: CD Horizon 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/K102886
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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