510(k) · Decided
Recalled · Class II · 2018CD Horizon 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 Nov 21, 2011 as substantially equivalent to K091974 (Medtronic Sofamor Danek USA, Inc., 2009) and 6 other predicates after a 25-day review. Its family tree reaches back 11 generations to 2004. 1 of the 669 devices in its family, counting itself, has a Class I recall. 596 later devices descend from it. It has been recalled once.
- Decided
- Nov 21, 2011
- Review
- 25 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 1
- Predicates
- 7
Its longest line of descent runs back 11 generations to K040583 (2004). 72 ancestors in all, the oldest K841189 (1984). 596 later devices descend from it, 37 citing it directly. 1 of the 669 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 7 generations between
- 3 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 2 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 1 generation backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- This deviceK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
- Descendant · cites it directly · 357 of its ownK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- Descendant · cites it directly · 286 of its ownK142847 CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc. · 2014
- Descendant · cites it directly · 244 of its ownK130646 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- Descendant · cites it directly · 243 of its ownK132639 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- Descendant · cites it directly · 211 of its ownK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
Show all 11 generations
- Root · 11 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 10 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 9 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 8 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 7 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 6 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 5 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 4 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 3 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 2 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 1 generation backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- This deviceK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011
Showing 5 of 596 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 596 · See all- K121680CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012 · cites it directly357descendants
- K142847CD HORIZON Spinal SystemMedtronic Sofamor Danck USA, Inc. · 2014 · cites it directly286descendants
- K130646CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013 · cites it directly244descendants
- K132639CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013 · cites it directly243descendants
- K122862CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012 · cites it directly211descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −10 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −9 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −8 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −7 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −6 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −5 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −4 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −3 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −2 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −1 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| 0 (this device) | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | — |
| +1 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| +1 | K142847 | CD HORIZON Spinal System | Medtronic Sofamor Danck USA, Inc. | 2014 | — |
| +1 | K130646 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| +1 | K132639 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| +1 | K122862 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
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 | 15 | 0 |
| 2005 | 8 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (7)
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…and indications for use of the subject devices are substantially equivalent to the predicate CD HORIZON® SOLERA™ screws and setscrews for use with 4.75mm diameter rods (K091974 SE 09/02/09, K102555 SE 11/17/10, K112473 SE 10/21/11 ), CD HORIZON® HA coated screws (K112555 SE XL KNSITH g df… | 2009 |
| * | K102555 | CD Horizon Spinal SystemSummary page 3…use of the subject devices are substantially equivalent to the predicate CD HORIZON® SOLERA™ screws and setscrews for use with 4.75mm diameter rods (K091974 SE 09/02/09, K102555 SE 11/17/10, K112473 SE 10/21/11 ), CD HORIZON® HA coated screws (K112555 SE XL KNSITH g dfy 09/27/11), CD HORI… | 2010 |
| * | K112473 | CD Horizon Spinal SystemSummary page 3…vices are substantially equivalent to the predicate CD HORIZON® SOLERA™ screws and setscrews for use with 4.75mm diameter rods (K091974 SE 09/02/09, K102555 SE 11/17/10, K112473 SE 10/21/11 ), CD HORIZON® HA coated screws (K112555 SE XL KNSITH g dfy 09/27/11), CD HORIZON® 5.5mm diameter r… | 2011 |
| * | K112555 | CD Horizon (R) Spinal SystemSummary page 3…D HORIZON® SOLERA™ screws and setscrews for use with 4.75mm diameter rods (K091974 SE 09/02/09, K102555 SE 11/17/10, K112473 SE 10/21/11 ), CD HORIZON® HA coated screws (K112555 SE XL KNSITH g dfy 09/27/11), CD HORIZON® 5.5mm diameter rods (K040962 SE 05/14/04), CD HORIZON® 6.0mm diameter… | 2011 |
| * | K040962 | Modification to CD Horizon Spinal SystemSummary page 4…02/09, K102555 SE 11/17/10, K112473 SE 10/21/11 ), CD HORIZON® HA coated screws (K112555 SE XL KNSITH g dfy 09/27/11), CD HORIZON® 5.5mm diameter rods (K040962 SE 05/14/04), CD HORIZON® 6.0mm diameter rods (K040072 SE 02/12/04) and CD HORIZON® screws for use with 4.5mm and 5.5mm rods (K04… | 2004 |
| * | K040072 | Modification to CD Horizon Spinal SystemSummary page 4…ORIZON® HA coated screws (K112555 SE XL KNSITH g dfy 09/27/11), CD HORIZON® 5.5mm diameter rods (K040962 SE 05/14/04), CD HORIZON® 6.0mm diameter rods (K040072 SE 02/12/04) and CD HORIZON® screws for use with 4.5mm and 5.5mm rods (K042025 SE 08/25/04). The TSRH® 5.5mm diameter rods were p… | 2004 |
| * | K042025 | Modification to CD Horizon Spinal SystemSummary page 4…), CD HORIZON® 5.5mm diameter rods (K040962 SE 05/14/04), CD HORIZON® 6.0mm diameter rods (K040072 SE 02/12/04) and CD HORIZON® screws for use with 4.5mm and 5.5mm rods (K042025 SE 08/25/04). The TSRH® 5.5mm diameter rods were previously cleared in K 103049 (SE 12/23/10) and K 111942 (08/30/11). The label… | 2004 |
| † | K103049 | TSRH Spinal System | 2010 |
| † | K111942 | TSRH Spinal Systems | 2011 |
What descends from it? (596)
See all 59637 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K121680 | CD Horizon Spinal System | 2012 | 357 |
| K142847 | CD HORIZON Spinal System | 2014 | 286 |
| K130646 | CD Horizon Spinal System | 2013 | 244 |
| K132639 | CD Horizon Spinal System | 2013 | 243 |
| K122862 | CD Horizon Spinal System | 2012 | 211 |
| K131321 | CD Horizon Spinal System | 2013 | 195 |
| K132328 | CD Horizon Spinal System | 2013 | 176 |
| K152604 | KYPHON HV-R Fenestrated Screw Cement, CD HORIZON Fenestrated Screw Set | 2016 | 159 |
| K152457 | CD HORIZON Spinal System | 2015 | 145 |
| K132471 | CD Horizon Spinal System | 2013 | 132 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 9, 2018 | Class II | Z-2603-2018 | Employee error | This lot has incorrectly been laser marked both on the screw head itself as well as the data carrier tag attached to the screw. The description on face two of the screw head and on the data carrier tag both incorrectly indicate a 5.5 mm… |
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 7 years and passes through 3 companies; a new generation was cleared every 4 months on median.
- 10 of the 72 ancestors have a recall of any class.
- Of its descendants, K121680 (Medtronic Sofamor Danek USA, Inc., 2012) has gone furthest, with 357 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 (324 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 implaats 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 poslerior, 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/K113174 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113174: 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/K113174
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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