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, Inc. · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Sep 15, 2011 as substantially equivalent to K031655 (Medtronic Sofamor Danek USA, Inc., 2003) and 9 other predicates after a 106-day review. Its family tree reaches back 9 generations to 2004. 128 later devices descend from it.
- Decided
- Sep 15, 2011
- Review
- 106 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 9 generations to K040583 (2004). 71 ancestors in all, the oldest K841189 (1984). 128 later devices descend from it, 2 citing it directly.
- 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 deviceK111510 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
- Descendant · cites it directly · 127 of its ownK121630 Range Spinal SystemK2m, Inc. · 2012
- Descendant · 2 generations on · 81 of its ownK130932 Firebird Spinal Fixation SystemOrthofix, Inc. · 2013 · Recalled
- Descendant · 3 generations on · 78 of its ownK151488 Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2015 · Recalled
- Descendant · 3 generations on · 73 of its ownK153428 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2016 · Recalled
- Descendant · 4 generations on · 61 of its ownK171082 Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System…Orthofix, Inc. · 2017 · Recalled
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 deviceK111510 CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2011
Showing 5 of 128 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 128 · See all- K121630Range Spinal SystemK2m, Inc. · 2012 · cites it directly127descendants
- K130932Firebird Spinal Fixation SystemOrthofix, Inc. · 2013 · 2 generations on81descendants
- K151488Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2015 · 3 generations on78descendants
- K153428Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation SystemOrthofix, Inc. · 2016 · 3 generations on73descendants
- K171082Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS Midline…Orthofix, Inc. · 2017 · 4 generations on61descendants
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) | K111510 | CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2011 | — |
| +1 | K121630 | Range Spinal System | K2m, Inc. | 2012 | — |
| +2 | K130932 | Firebird Spinal Fixation System | Orthofix, Inc. | 2013 | 1 |
| +3 | K151488 | Firebird Spinal Fixation System/Phoenix MIS Spinal Fixation System | Orthofix, Inc. | 2015 | 1 |
| +3 | K153428 | Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System | Orthofix, Inc. | 2016 | 1 |
| +4 | K171082 | Firebird Spinal Fixation System, Phoenix MIS Spinal Fixation System, JANUS… | Orthofix, Inc. | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 7 | 0 |
| 2002 | 5 | 0 |
| 2003 | 5 | 0 |
| 2004 | 16 | 0 |
| 2005 | 9 | 0 |
| 2006 | 5 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 7 | 0 |
| 2014 | 6 | 0 |
| 2015 | 8 | 0 |
| 2016 | 6 | 0 |
| 2017 | 7 | 0 |
| 2018 | 9 | 0 |
| 2019 | 6 | 0 |
| 2020 | 5 | 0 |
| 2021 | 8 | 0 |
| 2022 | 14 | 0 |
| 2023 | 16 | 0 |
| 2024 | 14 | 0 |
| 2025 | 9 | 0 |
| 2026 | 12 | 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.
Planning a device in NKB? 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? (10)
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 |
|---|---|---|---|
| * | K031655 | CD Horizon Spinal SystemSummary page 4…nstrated the subject Threaded Rods are substantially equivalent to CD HOREZON® Spinal System components manufactured by Medtronic Sofamor Danek and cleared by the FDA in K031655 (S.E. 6/27/2003), K042453 (S.E. 10/7/2004), K042962 (S.E. 12/14/2004), K043488 (S.E. 3/21/2005 ), K091974 (S.E. 9/2/2009), K96365… | 2003 |
| * | K042453 | Modification to Equation Fixation SystemSummary page 4…ded Rods are substantially equivalent to CD HOREZON® Spinal System components manufactured by Medtronic Sofamor Danek and cleared by the FDA in K031655 (S.E. 6/27/2003), K042453 (S.E. 10/7/2004), K042962 (S.E. 12/14/2004), K043488 (S.E. 3/21/2005 ), K091974 (S.E. 9/2/2009), K963655 (S.E. 11/27/1996), K9816… | 2004 |
| * | K042962 | Modification to CD Horizon Spinal SystemSummary page 4…equivalent to CD HOREZON® Spinal System components manufactured by Medtronic Sofamor Danek and cleared by the FDA in K031655 (S.E. 6/27/2003), K042453 (S.E. 10/7/2004), K042962 (S.E. 12/14/2004), K043488 (S.E. 3/21/2005 ), K091974 (S.E. 9/2/2009), K963655 (S.E. 11/27/1996), K981676 (S.E. 1/28/1999) and K9… | 2004 |
| * | K043488 | Modification to CD Horizon Spinal SystemSummary page 4…Spinal System components manufactured by Medtronic Sofamor Danek and cleared by the FDA in K031655 (S.E. 6/27/2003), K042453 (S.E. 10/7/2004), K042962 (S.E. 12/14/2004), K043488 (S.E. 3/21/2005 ), K091974 (S.E. 9/2/2009), K963655 (S.E. 11/27/1996), K981676 (S.E. 1/28/1999) and K993810( S.E. 2/3/2000). Addi… | 2005 |
| * | K091974 | Modification to CD Horizon Spinal SystemSummary page 4…nufactured by Medtronic Sofamor Danek and cleared by the FDA in K031655 (S.E. 6/27/2003), K042453 (S.E. 10/7/2004), K042962 (S.E. 12/14/2004), K043488 (S.E. 3/21/2005 ), K091974 (S.E. 9/2/2009), K963655 (S.E. 11/27/1996), K981676 (S.E. 1/28/1999) and K993810( S.E. 2/3/2000). Additionally, the geometry of t… | 2009 |
| * | K963655 | CD Horizon Anterior Spinal SystemSummary page 4…ofamor Danek and cleared by the FDA in K031655 (S.E. 6/27/2003), K042453 (S.E. 10/7/2004), K042962 (S.E. 12/14/2004), K043488 (S.E. 3/21/2005 ), K091974 (S.E. 9/2/2009), K963655 (S.E. 11/27/1996), K981676 (S.E. 1/28/1999) and K993810( S.E. 2/3/2000). Additionally, the geometry of the threaded rods are subs… | 1996 |
| * | K981676 | CD Horizon Spinal SystemSummary page 4…the FDA in K031655 (S.E. 6/27/2003), K042453 (S.E. 10/7/2004), K042962 (S.E. 12/14/2004), K043488 (S.E. 3/21/2005 ), K091974 (S.E. 9/2/2009), K963655 (S.E. 11/27/1996), K981676 (S.E. 1/28/1999) and K993810( S.E. 2/3/2000). Additionally, the geometry of the threaded rods are substantially equivalent to the… | 1999 |
| * | K993810 | CD Horizon Spinal SystemSummary page 4…7/2003), K042453 (S.E. 10/7/2004), K042962 (S.E. 12/14/2004), K043488 (S.E. 3/21/2005 ), K091974 (S.E. 9/2/2009), K963655 (S.E. 11/27/1996), K981676 (S.E. 1/28/1999) and K993810( S.E. 2/3/2000). Additionally, the geometry of the threaded rods are substantially equivalent to the predicate VERTEX® Spinal Sys… | 2000 |
| * | K090714 | Vertex Reconstruction System, Vertex Select Reconstruction SystemSummary page 4…8/1999) and K993810( S.E. 2/3/2000). Additionally, the geometry of the threaded rods are substantially equivalent to the predicate VERTEX® Spinal System threaded rods in K090714 (S.E. 4/17/2009) and K083071 (S.E. 11/14/2008). Summary of the Technological Characteristics: The purpose of this Traditional S… | 2009 |
| * | K083071 | Vertex Reconstruction SystemSummary page 4…/2000). Additionally, the geometry of the threaded rods are substantially equivalent to the predicate VERTEX® Spinal System threaded rods in K090714 (S.E. 4/17/2009) and K083071 (S.E. 11/14/2008). Summary of the Technological Characteristics: The purpose of this Traditional S10(k) is to add a threaded ge… | 2008 |
What descends from it? (128)
See all 1282 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a 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.
- 11 of the 71 ancestors have a recall of any class.
- Of its descendants, K121630 (K2m, Inc., 2012) has gone furthest, with 127 descendants of its own.
- 24 other devices also cite its predicate K031655.
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 (306 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 inay 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, 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/K111510 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111510: 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/K111510
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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