510(k) · Cleared
ClearedCD HORIZON Spinal System, Medtronic Navigated Reusable Instruments
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 Feb 13, 2015 as substantially equivalent to K142847 (Medtronic Sofamor Danck USA, Inc., 2014) and 6 other predicates after an 80-day review. Its family tree reaches back 15 generations to 2004. 1 of the 358 devices in its family, counting itself, has a Class I recall. 207 later devices descend from it.
- Decided
- Feb 13, 2015
- Review
- 80 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 15 generations to K040583 (2004). 150 ancestors in all, the oldest K841189 (1984). 207 later devices descend from it, 14 citing it directly. 1 of the 358 devices in this family, counting this one, has a Class I recall.
- Root · 15 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 11 generations between
- 3 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 2 generations backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 1 generation backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- This deviceK143375 CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- Descendant · cites it directly · 112 of its ownK153203 Navigation InstrumentsGlobus Medical, Inc. · 2016
- Descendant · cites it directly · 86 of its ownK170679 CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use…Medtronic Sofamor Danek · 2017
- Descendant · 2 generations on · 78 of its ownK161591 QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation…Globus Medical, Inc. · 2016
- Descendant · 3 generations on · 69 of its ownK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
- Descendant · 2 generations on · 54 of its ownK201407 CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2020
Show all 15 generations
- Root · 15 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 14 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 13 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 12 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 11 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 10 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 9 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 8 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 7 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 6 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 5 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 4 generations backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- 3 generations backK121680 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 2 generations backK122862 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2012
- 1 generation backK141605 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2014
- This deviceK143375 CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
Showing 5 of 207 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 207 · See all- K153203Navigation InstrumentsGlobus Medical, Inc. · 2016 · cites it directly112descendants
- K170679CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®…Medtronic Sofamor Danek · 2017 · cites it directly86descendants
- K161591QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc. · 2016 · 2 generations on78descendants
- K171651Excelsius GPSGlobus Medical, Inc. · 2017 · 3 generations on69descendants
- K201407CD Horizon™ Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2020 · 2 generations on54descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −14 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −13 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −12 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −11 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −10 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −9 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −8 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −7 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −6 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −5 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −4 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| −3 | K121680 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −2 | K122862 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2012 | — |
| −1 | K141605 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2014 | — |
| 0 (this device) | K143375 | CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| +1 | K153203 | Navigation Instruments | Globus Medical, Inc. | 2016 | — |
| +1 | K170679 | CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the… | Medtronic Sofamor Danek | 2017 | — |
| +2 | K161591 | QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments | Globus Medical, Inc. | 2016 | — |
| +3 | K171651 | Excelsius GPS | Globus Medical, Inc. | 2017 | 1 |
| +2 | K201407 | CD Horizon™ Spinal System | Medtronic Sofamor Danek USA, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 7 | 0 |
| 1996 | 2 | 0 |
| 1997 | 5 | 0 |
| 1998 | 6 | 0 |
| 1999 | 3 | 0 |
| 2000 | 11 | 0 |
| 2001 | 9 | 0 |
| 2002 | 8 | 0 |
| 2003 | 8 | 0 |
| 2004 | 19 | 0 |
| 2005 | 14 | 0 |
| 2006 | 8 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 6 | 0 |
| 2018 | 7 | 0 |
| 2019 | 9 | 0 |
| 2020 | 11 | 0 |
| 2021 | 20 | 1 |
| 2022 | 20 | 0 |
| 2023 | 27 | 0 |
| 2024 | 31 | 0 |
| 2025 | 35 | 0 |
| 2026 | 38 | 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 |
|---|---|---|---|
| * | K142847 | CD HORIZON Spinal SystemSummary page 6…Accessories (Simple, Powered); HBE 1. CD HORIZON® Spinal System Predicate Devices ! K142847 CD HORIZON® Spinal System (S.E. A001 CD HORIZON SOLERA VOYAGER Spinal System K143375 Medtr… | 2014 |
| * | K091974 | Modification to CD Horizon Spinal SystemSummary page 7…K143375 Page 2/8 10/27/2014) Primary Predicate ! K091974 CD HORIZON® Spinal System (S.E 9/2/2009) ! K113529 CD HORIZON® Spinal System (S.E 2/9/2011)… | 2009 |
| * | K113529 | CD Horizon Voyager Spinal SystemSummary page 7…10/27/2014) Primary Predicate ! K091974 CD HORIZON® Spinal System (S.E 9/2/2009) ! K113529 CD HORIZON® Spinal System (S.E 2/9/2011) ! K132639 CD HORIZON® Spinal System (S.E… | 2012 |
| * | K132639 | CD Horizon Spinal SystemSummary page 7…! K091974 CD HORIZON® Spinal System (S.E 9/2/2009) ! K113529 CD HORIZON® Spinal System (S.E 2/9/2011) ! K132639 CD HORIZON® Spinal System (S.E 11/25/2013) ! K102555 CD HORIZO… | 2013 |
| * | K102555 | CD Horizon Spinal SystemSummary page 7…(S.E 2/9/2011) ! K132639 CD HORIZON® Spinal System (S.E 11/25/2013) ! K102555 CD HORIZON® Spinal System (S.E 11/17/2010) ! K141605 CD HORIZO… | 2010 |
| * | K141605 | CD Horizon Spinal SystemSummary page 7…11/25/2013) ! K102555 CD HORIZON® Spinal System (S.E 11/17/2010) ! K141605 CD HORIZON® Spinal System (S.E 7/14/2014) 2. MEDTRONIC NAVIGATED REUSABLE INSTRUMENTS… | 2014 |
| * | K140454 | Navigated CD Horizon Solera Screwdriver/TapsSummary page 7…LE INSTRUMENTS For use with StealthStation® and IPC® POWEREASE™ Systems ! K140454 Navigated Instruments (S.E 5/22/2014) The predicates have not been subject to a design related… | 2014 |
What descends from it? (207)
See all 20714 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K153203 | Navigation Instruments | 2016 | 112 |
| K170679 | CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®… | 2017 | 86 |
| K201251 | CarboClear Navigated Instruments | 2020 | 9 |
| K183630 | SPINEART Navigation Instrument System | 2019 | 6 |
| K172166 | OLYMPIC Navigated Instruments | 2018 | 5 |
| K212007 | VERTICALE Navigation Instruments | 2021 | 4 |
| K190881 | Spinal Elements Navigated Instruments | 2019 | 4 |
| K183381 | Navigation Enabled Instruments | 2019 | 1 |
| K171321 | K2M Navigation Instruments | 2017 | 1 |
| K230369 | EUROPA™ Navigated Instruments | 2023 | 0 |
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 4 months on median.
- 21 of the 150 ancestors have a recall of any class.
- Of its descendants, K153203 (Globus Medical, Inc., 2016) has gone furthest, with 112 descendants of its own.
- 1 other device also cites its predicate K142847.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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, or lordosis), tumor…
Read the full statement (455 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, 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 progressive spinal deformities (i.e., scoliosis, kyphosis, or lordosis) including idiopathic scoliosis, neuromuscular scoliosis, and congenital scoliosis. Additionally, the CD HORIZON® Spinal System is intended to treat pediatric patients diagnosed with the following conditions: spondylolisthesis/spondylolysis, fracture caused by tumor and/or trauma, pseudarthrosis, and/or failed previous fusion. 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.
Medtronic Navigated Reusable Instruments are intended to be used during the preparation and placement of Medtronic screws during spinal surgery to assist the surgeon in precisely locating anatomical structures in either open, or minimally invasive, procedures. Medtronic Navigated Reusable Instruments are specifically designed for use with the StealthStation® System, which is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a skull, a long bone, or vertebra, can be identified relative to a CT or MR-based model, fluoroscopy images, or digitized landmarks of the anatomy. Medtronic Navigated Reusable Instruments are also compatible with the IPC® POWEREASE™ System.
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/K143375 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143375: CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143375
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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