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 · NKB Thoracolumbosacral Pedicle Screw System
Cleared on Sep 15, 2011 as substantially equivalent to K091445 (Medtronic Sofamor Danek, 2010) after a 112-day review. Its family tree reaches back 5 generations to 1999. 261 later devices descend from it.
- Decided
- Sep 15, 2011
- Review
- 112 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K990745 (1999). 19 ancestors in all, the oldest K781443 (1978). 261 later devices descend from it, 8 citing it directly.
- Root · 5 generations backK990745 Modification to Synthes Universal Spinal SystemSynthes Spine · 1999
- 4 generations backK992739 Click'xSynthes Spine · 2000 · Recalled
- 3 generations backK052123 Synthes Pangea SystemSynthes (Usa) · 2005
- 2 generations backK082572 Uss Iliosacral, Uss PolyaxialSynthes Spine · 2008
- 1 generation backK091445 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2010
- This deviceK111457 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2011
- Descendant · cites it directly · 132 of its ownK132471 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013
- Descendant · cites it directly · 127 of its ownK121630 Range Spinal SystemK2m, Inc. · 2012
- Descendant · cites it directly · 93 of its ownK113044 Synthes MirsSynthes Spine · 2011 · Recalled
- Descendant · cites it directly · 85 of its ownK140276 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014
- Descendant · 2 generations on · 83 of its ownK142381 Xia 3 Spinal SystemStryker Corp. · 2014
Showing 5 of 261 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 261 · See all- K132471CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2013 · cites it directly132descendants
- K121630Range Spinal SystemK2m, Inc. · 2012 · cites it directly127descendants
- K113044Synthes MirsSynthes Spine · 2011 · cites it directly93descendants
- K140276CD Horizon Spinal SystemMedtronic Sofamor Danek · 2014 · cites it directly85descendants
- K142381Xia 3 Spinal SystemStryker Corp. · 2014 · 2 generations on83descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K990745 | Modification to Synthes Universal Spinal System | Synthes Spine | 1999 | — |
| −4 | K992739 | Click'x | Synthes Spine | 2000 | 1 |
| −3 | K052123 | Synthes Pangea System | Synthes (Usa) | 2005 | — |
| −2 | K082572 | Uss Iliosacral, Uss Polyaxial | Synthes Spine | 2008 | — |
| −1 | K091445 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2010 | — |
| 0 (this device) | K111457 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2011 | — |
| +1 | K132471 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2013 | — |
| +1 | K121630 | Range Spinal System | K2m, Inc. | 2012 | — |
| +1 | K113044 | Synthes Mirs | Synthes Spine | 2011 | 3 |
| +1 | K140276 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2014 | — |
| +2 | K142381 | Xia 3 Spinal System | Stryker Corp. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2003 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 5 | 0 |
| 2013 | 9 | 0 |
| 2014 | 18 | 0 |
| 2015 | 16 | 0 |
| 2016 | 14 | 0 |
| 2017 | 22 | 0 |
| 2018 | 17 | 0 |
| 2019 | 12 | 0 |
| 2020 | 14 | 0 |
| 2021 | 12 | 0 |
| 2022 | 19 | 0 |
| 2023 | 28 | 0 |
| 2024 | 29 | 0 |
| 2025 | 22 | 0 |
| 2026 | 23 | 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? (1)
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 |
|---|---|---|---|
| * | K091445 | CD Horizon Spinal SystemSummary page 3…alence: The design features, materials used, manufacturing and sterilization methods and indications for use are equivalent to the CD HORIZON® Spinal System as stated in K091445 (SE 09/27/10) with the exception of broadening a portion of the adult indications to include the pediatric population for the ind… | 2010 |
What descends from it? (261)
See all 2618 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132471 | CD Horizon Spinal System | 2013 | 132 |
| K121630 | Range Spinal System | 2012 | 127 |
| K113044 | Synthes Mirs | 2011 | 93 |
| K140276 | CD Horizon Spinal System | 2014 | 85 |
| K131615 | Polaris Spinal System | 2013 | 70 |
| K133746 | Polaris Spinal System | 2014 | 67 |
| K122877 | Range Spinal System, Small Stature | 2013 | 34 |
| K141291 | Vertiform Posterior Fixation System | 2014 | 2 |
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 12 years and passes through 3 companies; a new generation was cleared every 1.8 years on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K132471 (Medtronic Sofamor Danek USA, Inc., 2013) has gone furthest, with 132 descendants of its own.
- 26 other devices also cite its predicate K091445.
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 (325 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 3.5Smm 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 fractures 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/K111457 · printed Nov 5, 2026
Cite this page
510(k) Report. “K111457: CD Horizon Spinal System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K111457
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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