510(k) · Decided
DecidedCD Horizon Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Sep 27, 2010 as substantially equivalent to K071668 (Paradigm Spine, 2008) and 2 other predicates after a 500-day review. Its family tree reaches back 4 generations to 1999. 1 of the 600 devices in its family, counting itself, has a Class I recall. 581 later devices descend from it.
- Decided
- Sep 27, 2010
- Review
- 500 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K990745 (1999). 18 ancestors in all, the oldest K781443 (1978). 581 later devices descend from it, 27 citing it directly. 1 of the 600 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 3 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 2 generations backK052123 Synthes Pangea SystemSynthes (Usa) · 2005
- 1 generation backK082572 Uss Iliosacral, Uss PolyaxialSynthes Spine · 2008
- This deviceK091445 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010
- Descendant · cites it directly · 269 of its ownK110070 TSRH Spinal SystemMedtronic Sofamor Danck USA, Inc. · 2011
- Descendant · cites it directly · 261 of its ownK111457 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2011
- Descendant · cites it directly · 260 of its ownK113395 Revere 4.5 Stabilization SystemGlobus Medical, Inc. · 2012
- Descendant · cites it directly · 251 of its ownK113666 Xia 3 Spinal SystemStryker Spine · 2012
- Descendant · 2 generations on · 242 of its ownK111942 TSRH Spinal SystemsMedtronic Sofamor Danek USA, Inc. · 2011
Showing 5 of 581 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 581 · See all- K110070TSRH Spinal SystemMedtronic Sofamor Danck USA, Inc. · 2011 · cites it directly269descendants
- K111457CD Horizon Spinal SystemMedtronic Sofamor Danek · 2011 · cites it directly261descendants
- K113395Revere 4.5 Stabilization SystemGlobus Medical, Inc. · 2012 · cites it directly260descendants
- K113666Xia 3 Spinal SystemStryker Spine · 2012 · cites it directly251descendants
- K111942TSRH Spinal SystemsMedtronic Sofamor Danek USA, Inc. · 2011 · 2 generations on242descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −3 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −2 | K052123 | Synthes Pangea System | Synthes (Usa) | 2005 | — |
| −1 | K082572 | Uss Iliosacral, Uss Polyaxial | Synthes Spine | 2008 | — |
| 0 (this device) | K091445 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2010 | — |
| +1 | K110070 | TSRH Spinal System | Medtronic Sofamor Danck USA, Inc. | 2011 | — |
| +1 | K111457 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2011 | — |
| +1 | K113395 | Revere 4.5 Stabilization System | Globus Medical, Inc. | 2012 | — |
| +1 | K113666 | Xia 3 Spinal System | Stryker Spine | 2012 | — |
| +2 | K111942 | TSRH Spinal Systems | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2003 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 5 | 0 |
| 2012 | 15 | 0 |
| 2013 | 24 | 0 |
| 2014 | 32 | 0 |
| 2015 | 41 | 0 |
| 2016 | 35 | 0 |
| 2017 | 40 | 0 |
| 2018 | 39 | 0 |
| 2019 | 26 | 0 |
| 2020 | 36 | 0 |
| 2021 | 31 | 1 |
| 2022 | 40 | 0 |
| 2023 | 59 | 0 |
| 2024 | 59 | 0 |
| 2025 | 50 | 0 |
| 2026 | 48 | 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 NKB device
- #1 K223494 CD Horizon Spinal Systemscore 40.4 · 30 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K071668 | Orthobiom Spinal SystemSummary page 3…res, material and indications for use of the CD HORIZON®-Spinal System are substantially equivalent to the Orthobiom Spinal System (Paradigm Spine) previously cleared in K071668 (SE 07/02/2008) and to the Synthes Small Stature USS Spinal System applications K082572 (SE 11/24/08) and in K994121 (SE 10/17/00… | 2008 |
| * | K082572 | Uss Iliosacral, Uss PolyaxialSummary page 3…equivalent to the Orthobiom Spinal System (Paradigm Spine) previously cleared in K071668 (SE 07/02/2008) and to the Synthes Small Stature USS Spinal System applications K082572 (SE 11/24/08) and in K994121 (SE 10/17/00). No new implants were included in this application as this submission sought only to e… | 2008 |
| * | K994121 | Small Stature UssSummary page 3…Spinal System (Paradigm Spine) previously cleared in K071668 (SE 07/02/2008) and to the Synthes Small Stature USS Spinal System applications K082572 (SE 11/24/08) and in K994121 (SE 10/17/00). No new implants were included in this application as this submission sought only to expand the indication for post… | 2000 |
| † | K091974 | Modification to CD Horizon Spinal System | 2009 |
What descends from it? (581)
See all 58127 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K110070 | TSRH Spinal System | 2011 | 269 |
| K111457 | CD Horizon Spinal System | 2011 | 261 |
| K113395 | Revere 4.5 Stabilization System | 2012 | 260 |
| K113666 | Xia 3 Spinal System | 2012 | 251 |
| K120291 | OP Spine System | 2012 | 138 |
| K132471 | CD Horizon Spinal System | 2013 | 132 |
| K121630 | Range Spinal System | 2012 | 127 |
| K121342 | Xia 4.5 Spinal System | 2012 | 88 |
| K140276 | CD Horizon Spinal System | 2014 | 85 |
| K130932 | Firebird Spinal Fixation System | 2013 | 81 |
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 · 4 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 18 ancestors has a recall of any class.
- Of its descendants, K110070 (Medtronic Sofamor Danck USA, Inc., 2011) has gone furthest, with 269 descendants of its own.
- 2 other devices also cite its predicate K071668.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · NKB
24in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NKB
61in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NKB
1in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · NKB
1,171in 2025
MAUDE reports naming product code NKB, 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 | 38 | 87 | 4 | 34 |
| 2008 | 36 | 59 | 5 | 82 |
| 2009 | 44 | 71 | 33 | 171 |
| 2010 | 37 | 111 | 4 | 462 |
| 2011 | 48 | 84 | 3 | 577 |
| 2012 | 60 | 79 | 13 | 1,747 |
| 2013 | 35 | 73 | 0 | 1,962 |
| 2014 | 46 | 90 | 3 (1) | 1,671 |
| 2015 | 55 | 90 | 3 | 1,446 |
| 2016 | 50 | 84 | 1 | 1,585 |
| 2017 | 63 | 69 | 1 | 1,618 |
| 2018 | 56 | 61 | 3 | 1,684 |
| 2019 | 39 | 84 | 1 | 1,915 |
| 2020 | 48 | 68 | 1 | 2,076 |
| 2021 | 32 | 61 | 0 | 1,745 |
| 2022 | 34 | 88 | 5 | 1,339 |
| 2023 | 44 | 72 | 2 | 919 |
| 2024 | 39 | 57 | 3 | 1,614 |
| 2025 | 24 | 61 | 1 | 1,171 |
| 2026 | 30 | 91 | 3 | — |
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, kyphosis and/or lordosis)…
Read the full statement (304 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, kyphosis 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® LEGACY™ 3.5mm 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 3.5mm 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 SPIRE™ Plate is a posterior, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T1-S1) 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K091445 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091445: 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/K091445
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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