510(k) · Decided
DecidedCD Horizon (R) Spinal System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic Sofamor Danek USA, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Sep 27, 2011 as substantially equivalent to K091974 (Medtronic Sofamor Danek USA, Inc., 2009) and 2 other predicates after a 25-day review. Its family tree reaches back 9 generations to 2004. 1 of the 666 devices in its family, counting itself, has a Class I recall. 597 later devices descend from it.
- Decided
- Sep 27, 2011
- Review
- 25 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K040583 (2004). 68 ancestors in all, the oldest K841189 (1984). 597 later devices descend from it, 2 citing it directly. 1 of the 666 devices in this family, counting this one, has a Class I recall.
- Root · 9 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 5 generations between
- 3 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 2 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 1 generation backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- This deviceK112555 CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
- Descendant · cites it directly · 596 of its ownK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- Descendant · 2 generations on · 357 of its ownK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- Descendant · 2 generations on · 286 of its ownK142847 CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc. · 2014
- Descendant · 2 generations on · 244 of its ownK130646 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- Descendant · 2 generations on · 243 of its ownK132639 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
Show all 9 generations
- Root · 9 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 8 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 7 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 6 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 5 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 4 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 3 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 2 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 1 generation backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- This deviceK112555 CD Horizon (R) Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
Showing 5 of 597 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub5 generations on · 2021
Most influential descendants
Showing 5 of 597 · See all- K113174CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · cites it directly596descendants
- K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012 · 2 generations on357descendants
- K142847CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc. · 2014 · 2 generations on286descendants
- K130646CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013 · 2 generations on244descendants
- K132639CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013 · 2 generations on243descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −8 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −7 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −6 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −5 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −4 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −3 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −2 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −1 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| 0 (this device) | K112555 | CD Horizon (R) Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| +1 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| +2 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| +2 | K142847 | CD HORIZON Spinal System | Medtronic Sofamor Danck USA, Inc. | 2014 | — |
| +2 | K130646 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| +2 | K132639 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2001 | 6 | 0 |
| 2002 | 5 | 0 |
| 2003 | 6 | 0 |
| 2004 | 14 | 0 |
| 2005 | 8 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 7 | 0 |
| 2013 | 20 | 0 |
| 2014 | 27 | 0 |
| 2015 | 34 | 0 |
| 2016 | 33 | 0 |
| 2017 | 42 | 0 |
| 2018 | 42 | 0 |
| 2019 | 33 | 0 |
| 2020 | 43 | 0 |
| 2021 | 43 | 1 |
| 2022 | 45 | 0 |
| 2023 | 62 | 0 |
| 2024 | 57 | 0 |
| 2025 | 55 | 0 |
| 2026 | 53 | 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 |
|---|---|---|---|
| * | K091974 | Modification to CD Horizon Spinal SystemSummary page 3…s and indications for use of the subject screws are substantially equivalent to the predicate CD HORIZON® Spinal System SOLERA™ screws for use with 4.75mm diameter rods (K091974 SE 09/02/09), CD HORIZON® HA coated screws (K043151 SE 02/01/05) and TSRH® HA coated screws (K091797 SE 04/30/10). The labeling… | 2009 |
| * | K043151 | Modification to: CD Horizon Spinal SystemSummary page 3…substantially equivalent to the predicate CD HORIZON® Spinal System SOLERA™ screws for use with 4.75mm diameter rods (K091974 SE 09/02/09), CD HORIZON® HA coated screws (K043151 SE 02/01/05) and TSRH® HA coated screws (K091797 SE 04/30/10). The labeling is identical to that cleared in K102886 (SE 01/26/11… | 2005 |
| * | K091797 | TSRH Spinal SystemSummary page 3…ZON® Spinal System SOLERA™ screws for use with 4.75mm diameter rods (K091974 SE 09/02/09), CD HORIZON® HA coated screws (K043151 SE 02/01/05) and TSRH® HA coated screws (K091797 SE 04/30/10). The labeling is identical to that cleared in K102886 (SE 01/26/11). Discussion of the Non-Clinical Testing Non-c… | 2010 |
What descends from it? (597)
See all 5972 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 4 months on median.
- 10 of the 68 ancestors have a recall of any class.
- Of its descendants, K113174 (Medtronic Sofamor Danek USA, Inc., 2011) has gone furthest, with 596 descendants of its own.
- 17 other devices also cite its predicate K091974.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 (326 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. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, and fracture caused by tumor and/or trauma. These devices are 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, single level, 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/K112555 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112555: CD Horizon (R) 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/K112555
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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