510(k) · Cleared
ClearedCD 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 25, 2013 as substantially equivalent to K102807 (Medtronic Sofamor Danek, Inc., 2010) and 2 other predicates after a 94-day review. Its family tree reaches back 12 generations to 2004. 1 of the 325 devices in its family, counting itself, has a Class I recall. 243 later devices descend from it.
- Decided
- Nov 25, 2013
- Review
- 94 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K040583 (2004). 81 ancestors in all, the oldest K841189 (1984). 243 later devices descend from it, 7 citing it directly. 1 of the 325 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 8 generations between
- 3 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 2 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 1 generation backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- This deviceK132639 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- Descendant · cites it directly · 207 of its ownK143375 CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015
- Descendant · 2 generations on · 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 · 3 generations on · 78 of its ownK161591 QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation…Globus Medical, Inc. · 2016
- Descendant · 4 generations on · 69 of its ownK171651 Excelsius GPSGlobus Medical, Inc. · 2017 · Recalled
Show all 12 generations
- Root · 12 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 11 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 10 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 9 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 8 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 7 generations backK052187 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 6 generations backK053101 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- 5 generations backK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- 4 generations backK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- 3 generations backK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
- 2 generations backK112473 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- 1 generation backK113174 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2011 · Recalled
- This deviceK132639 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
Showing 5 of 243 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 243 · See all- K143375CD HORIZON Spinal System, Medtronic Navigated Reusable InstrumentsMedtronic Sofamor Danek USA, Inc. · 2015 · cites it directly207descendants
- K153203Navigation InstrumentsGlobus Medical, Inc. · 2016 · 2 generations on112descendants
- 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 · 3 generations on78descendants
- K171651Excelsius GPSGlobus Medical, Inc. · 2017 · 4 generations on69descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −11 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −10 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −9 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −8 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −7 | K052187 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −6 | K053101 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| −5 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| −4 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| −3 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
| −2 | K112473 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| −1 | K113174 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2011 | 1 |
| 0 (this device) | K132639 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| +1 | K143375 | CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments | Medtronic Sofamor Danek USA, Inc. | 2015 | — |
| +2 | K153203 | Navigation Instruments | Globus Medical, Inc. | 2016 | — |
| +1 | K170679 | CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the… | Medtronic Sofamor Danek | 2017 | — |
| +3 | K161591 | QUARTEX™ Occipito-Cervico-Thoracic Spinal System, Globus Navigation Instruments | Globus Medical, Inc. | 2016 | — |
| +4 | K171651 | Excelsius GPS | Globus Medical, Inc. | 2017 | 1 |
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 | 6 | 0 |
| 2001 | 6 | 0 |
| 2002 | 5 | 0 |
| 2003 | 6 | 0 |
| 2004 | 17 | 0 |
| 2005 | 10 | 0 |
| 2006 | 5 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 5 | 0 |
| 2016 | 4 | 0 |
| 2017 | 10 | 0 |
| 2018 | 9 | 0 |
| 2019 | 11 | 0 |
| 2020 | 14 | 0 |
| 2021 | 21 | 1 |
| 2022 | 24 | 0 |
| 2023 | 34 | 0 |
| 2024 | 33 | 0 |
| 2025 | 38 | 0 |
| 2026 | 40 | 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 |
|---|---|---|---|
| * | K102807 | CD Horizon Spinal SystemSummary page 4…edicate Devices Used to Claim Substantial Equivalence The subject rods are substantially equivalent to the predicate CI) H-ORIZON® Spinal System rods (K 102807 S.F. 11/17/2010. KI 113174 S.F. 11/2 1/2011. K052747 S.F. 10/28/2005). The subject percutaneous rod inserter is… | 2010 |
| * | K113174 | CD Horizon Spinal SystemSummary page 4…Substantial Equivalence The subject rods are substantially equivalent to the predicate CI) H-ORIZON® Spinal System rods (K 102807 S.F. 11/17/2010. KI 113174 S.F. 11/2 1/2011. K052747 S.F. 10/28/2005). The subject percutaneous rod inserter is substantially equivalent… | 2011 |
| * | K052747 | Modification to:CD Horizon Spinal SystemSummary page 4…The subject rods are substantially equivalent to the predicate CI) H-ORIZON® Spinal System rods (K 102807 S.F. 11/17/2010. KI 113174 S.F. 11/2 1/2011. K052747 S.F. 10/28/2005). The subject percutaneous rod inserter is substantially equivalent to the predicate CD HIORIZON® S… | 2005 |
What descends from it? (243)
See all 2437 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143375 | CD HORIZON Spinal System, Medtronic Navigated Reusable Instruments | 2015 | 207 |
| K170679 | CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC®… | 2017 | 86 |
| K162494 | CD HORIZON® Spinal System | 2016 | 27 |
| K143569 | CD HORIZON Spinal System | 2015 | 15 |
| K173249 | CD HORIZON™ Spinal System | 2018 | 1 |
| K254165 | Infinity™ OCT System | 2026 | 0 |
| K152248 | CD HORIZON Spinal System | 2015 | 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 · 5 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 4 months on median.
- 11 of the 81 ancestors have a recall of any class.
- Of its descendants, K143375 (Medtronic Sofamor Danek USA, Inc., 2015) has gone furthest, with 207 descendants of its own.
- 8 other devices also cite its predicate K102807.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Trhe CD HORIZON® Spinal Systemn 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 stenlosis: curvatures (i.e., scoliosis, kyphosis arid/or lordosis)…
Read the full statement (322 words)
Trhe CD HORIZON® Spinal Systemn 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 stenlosis: curvatures (i.e., scoliosis, kyphosis arid/or lordosis); tumnor: pseudarthrosis; and/or failed previous fusion.
Except for hooks, when used as anl anterolateral thoracic/lumnbar system. the CD) HORIZON® Spinal System may also be used for thle samne indications as an adjunct to Fusion.
With the exception ofdlegenerative disc disease, the CD HORIZON® L-EGACYTM 3.5mmn rods and tile CD HORIZON® Spinal System PEEK rods and associated components ma)' be used for the aforementioned indications in skeletally mnature patients as anl adjunct to fusion. Thle 3.51nn rods mnay be used for the specific pediatric indications noted below.
When used for posterior non-cervical pedicle screw fixation in pediatric patients. the CD I IORIZON® Spinal Systemn implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. Additionally, the ClD HORIZON® Spinal Systemn is intended to treat pediatric patients diagnosed with the Following conditions: sponldylolisthiesis: firacture/dislocation: and/or traumna. These devices are to be used with autogral't and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach,
The CD HORIZON SPIRETNI Plate is a posterior, single level. non-pedicle supplemental Fixation device intended for use in the non-cervical spine (TI-SI) as an adjunct to fusion in skeletally mature patients. It is intended for plate fixation/attachmient to spinous processes for thle purpose of achieving supplemental Fixation in thle flollowing conditions: degenerative disc disease (as previously defined): spondvlolisthesis. trauma: and/or tumor.
In order to achieve additional levels of' fixation, the CD) IIORIZON® Spinal System rods may be connected to thle VERTEX® Reconstruction System with the VERTEX®R rod connector. Refer to the VERTEX®9 Reconstruction Systemn Package Insert for a list of the VERTEX® indications of use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132639 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132639: 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/K132639
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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