510(k) · Cleared
ClearedTitanium CD 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 Feb 6, 1997 after a 209-day review. The FDA summary names no predicate by number. 254 later devices descend from it.
- Decided
- Feb 6, 1997
- Review
- 209 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 0
254 later devices descend from it, 3 citing it directly.
- This deviceK962708 Titanium CD Horizon Spinal SystemSofamor Danek USA,Inc. · 1997
- 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 254 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 254 · 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) | K962708 | Titanium CD Horizon Spinal System | Sofamor Danek USA,Inc. | 1997 | — |
| +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 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 7 | 0 |
| 2013 | 7 | 0 |
| 2014 | 7 | 0 |
| 2015 | 9 | 0 |
| 2016 | 14 | 0 |
| 2017 | 16 | 0 |
| 2018 | 13 | 0 |
| 2019 | 14 | 0 |
| 2020 | 18 | 0 |
| 2021 | 13 | 0 |
| 2022 | 17 | 0 |
| 2023 | 23 | 0 |
| 2024 | 27 | 0 |
| 2025 | 26 | 0 |
| 2026 | 18 | 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?
The FDA summary names no predicate by number.
What descends from it? (254)
See all 2543 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- 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 Titanium CD HORIZON™ Spinal System, when using screws for pedicle fixation, is 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.…
Read the full statement (386 words)
The Titanium CD HORIZON™ Spinal System, when using screws for pedicle fixation, is 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.
Except for situations where screws are attached to the pedicles of the [umbar and sacral spine via a posterior surgical spproach in a Titanium CD HORIZON™ construct for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the L5-S1 vertebral joint, the specific indications for the Titanium 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, lordosis
Fracture
Unsuccessful previous attempts at spinal fusion
Tumor resection
NOTA BENE: The Titanium CD HORIZON™ Semal System Is limited to hon-cervical use. The titanium alioy CD HORIZON™ screws and the titanium alloy TSRH® Variable Angle Screws, when used as pedicle screws with the Titanium 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 pedicie screw fixation as described above, the screws are indicated only for insertion no higher than L3 and not lower than the sacrum. Otherwise the titanium alloy CD HORIZON™ screws and the titanium alloy TSRH® Variable Angle Scraws, when used with the Titanium CD HORIZON™ Spinal System, are intended for sacral/iliac attachment only. All of the titanium alloy CD HORIZON™ hooks are intended for thoracic and/or lumbar attachwnent only. The titanium alloy TSRH® Low Profile CROSSLINK® Offset Plate, the titanium alloy TSRH® Low Profile CROSSLINK® plates, and the titanium alloy CD HORIZON™ Low Profile MULTI-SPAN™ 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/K962708 · printed Nov 6, 2026
Cite this page
510(k) Report. “K962708: Titanium 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/K962708
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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