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 Dec 5, 1996 after a 220-day review. The FDA summary names no predicate by number. 1 of the 380 devices in its family, counting itself, has a Class I recall. 379 later devices descend from it.
- Decided
- Dec 5, 1996
- Review
- 220 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 0
379 later devices descend from it, 11 citing it directly. 1 of the 380 devices in this family, counting this one, has a Class I recall.
- This deviceK961633 CD Horizon Spinal SystemSofamor Danek USA,Inc. · 1996
- Descendant · cites it directly · 251 of its ownK982914 Aesculap Spine System Evolution: Additional ComponentsAesculap, Inc. · 1998
- Descendant · cites it directly · 251 of its ownK980484 Aesculap Spine System EvolutionAesculap, Inc. · 1998
- Descendant · 2 generations on · 250 of its ownK990118 Isobar Spinal SystemScien'Tx USA, Inc. · 1999
- Descendant · 3 generations on · 131 of its ownK061162 Bar Pedicle Screw Spinal Fixation System, Model 2020Applied Spine Technologies, Inc. · 2006
- Descendant · 4 generations on · 130 of its ownK092624 Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2009 · Recalled
Showing 5 of 379 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub3 generations on · 2021
Most influential descendants
Showing 5 of 379 · See all- K982914Aesculap Spine System Evolution: Additional ComponentsAesculap, Inc. · 1998 · cites it directly251descendants
- K980484Aesculap Spine System EvolutionAesculap, Inc. · 1998 · cites it directly251descendants
- K990118Isobar Spinal SystemScien'Tx USA, Inc. · 1999 · 2 generations on250descendants
- K061162Bar Pedicle Screw Spinal Fixation System, Model 2020Applied Spine Technologies, Inc. · 2006 · 3 generations on131descendants
- K092624Firebird Spinal Fixation SystemBlackstone Medical, Inc. · 2009 · 4 generations on130descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K961633 | CD Horizon Spinal System | Sofamor Danek USA,Inc. | 1996 | — |
| +1 | K982914 | Aesculap Spine System Evolution: Additional Components | Aesculap, Inc. | 1998 | — |
| +1 | K980484 | Aesculap Spine System Evolution | Aesculap, Inc. | 1998 | — |
| +2 | K990118 | Isobar Spinal System | Scien'Tx USA, Inc. | 1999 | — |
| +3 | K061162 | Bar Pedicle Screw Spinal Fixation System, Model 2020 | Applied Spine Technologies, Inc. | 2006 | — |
| +4 | K092624 | Firebird Spinal Fixation System | Blackstone Medical, Inc. | 2009 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2004 | 5 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 9 | 0 |
| 2013 | 9 | 0 |
| 2014 | 16 | 0 |
| 2015 | 20 | 0 |
| 2016 | 17 | 0 |
| 2017 | 20 | 0 |
| 2018 | 20 | 0 |
| 2019 | 18 | 0 |
| 2020 | 23 | 0 |
| 2021 | 19 | 1 |
| 2022 | 23 | 0 |
| 2023 | 31 | 0 |
| 2024 | 47 | 0 |
| 2025 | 38 | 0 |
| 2026 | 41 | 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? (379)
See all 37911 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982914 | Aesculap Spine System Evolution: Additional Components | 1998 | 251 |
| K980484 | Aesculap Spine System Evolution | 1998 | 251 |
| K133350 | Revere Stabilization System | 2014 | 93 |
| K121764 | CD Horizon Spinal System | 2012 | 45 |
| K140529 | Everest Spinal System | 2014 | 31 |
| K143569 | CD HORIZON Spinal System | 2015 | 15 |
| K081978 | Reliance Spinal Screw System | 2009 | 8 |
| K101112 | Reliance Spinal Screw System | 2010 | 7 |
| K110896 | Reliance Spinal Screw System | 2012 | 5 |
| K141147 | Range Spinal System | 2014 | 1 |
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 · 3 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K982914 (Aesculap, Inc., 1998) has gone furthest, with 251 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?
The CD HORIZON™ Spinal System is intended to provide temporary stabilization and to help augment the development of a solid spinal fusion. Except for situations using pedicle screws in 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…
Read the full statement (373 words)
The CD HORIZON™ Spinal System is intended to provide temporary stabilization and to help augment the development of a solid spinal fusion. Except for situations using pedicle screws in 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 (d) who are having the device removed after the development of a solid fusion mass, the specific indications for the CD HORIZON™ Spinal System are the following:
1. 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, and lordosis
Fracture
Unsuccessful previous attempts at spinal fusion
Tumor resection
The CD HORIZON™ Spinal System is intended for use only in the thoracic, lumbar, and/or sacral levels of the posterior spine. The CD HORIZON™ Spinal System is limited to non-cervical use. The CD HORIZON™ Screws, TSRH® Variable Angle Screws, LIBERTY® screws, and/or DYNA-LOK® bolts, when used as pedicle screws with the CD HORIZON™ Spinal System, are intended only for 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; and (d) who are having the device removed after the development of a solid fusion mass. When used for pedicle screw fixation as described above, the screws are indicated only for insertion no higher than L3 and not lower than the sacrum. Otherwise the CD HORIZON™ screws, TSRH® Variable Angle Screws, LIBERTY® screws, and/or DYNA-LOK® bolts, when used with the CD HORIZON™ Spinal System, are intended for sacroiliac attachment only. The CCD™ Screw for Sacral Block and CCD™ Conical Fixation Screws are intended for sacroiliac attachment only. All of the CD HORIZON™ hooks are intended for thoracic and/or lumbar attachment only. GDLH™ CROSSLINK® Bars, CD HORIZON™ Low Profile CROSSLINK® plates, and TSRH® CROSSLINK® plates are intended for posterior thoracic, lumbar, and/or sacral use 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/K961633 · printed Nov 6, 2026
Cite this page
510(k) Report. “K961633: 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/K961633
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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