510(k) · Cleared
Recalled · 2007CD 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 Oct 25, 2006 as substantially equivalent to K042025 (Medtronic Sofamor Danek, Inc., 2004) and 1 other predicate after a 232-day review. Its family tree reaches back 3 generations to 2004. 1 of the 836 devices in its family, counting itself, has a Class I recall. 822 later devices descend from it. It has been recalled 34 times.
- Decided
- Oct 25, 2006
- Review
- 232 days
- Class
- Class II
- Product code
- NKB
- Recalls
- 34
- Predicates
- 3
Its longest line of descent runs back 3 generations to K040583 (2004). 13 ancestors in all, the oldest K980288 (1998). 822 later devices descend from it, 2 citing it directly. 1 of the 836 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 2 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 1 generation backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- This deviceK060615 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2006
- Descendant · cites it directly · 821 of its ownK063670 Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2007
- Descendant · 2 generations on · 779 of its ownK082236 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2008
- Descendant · 3 generations on · 776 of its ownK091442 CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009
- Descendant · 3 generations on · 656 of its ownK091974 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · Recalled
- Descendant · 4 generations on · 598 of its ownK102555 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010
Showing 5 of 822 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K211616 ExcelsiusHub7 generations on · 2021
Most influential descendants
Showing 5 of 822 · See all- K063670Modifications to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2007 · cites it directly821descendants
- K082236CD Horizon Spinal SystemMedtronic Sofamor Danek · 2008 · 2 generations on779descendants
- K091442CD Horizon Spinal SystemMedtronic Sofamor Danek · 2009 · 3 generations on776descendants
- K091974Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2009 · 3 generations on656descendants
- K102555CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2010 · 4 generations on598descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −2 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −1 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| 0 (this device) | K060615 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2006 | — |
| +1 | K063670 | Modifications to CD Horizon Spinal System | Medtronic Sofamor Danek | 2007 | — |
| +2 | K082236 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2008 | — |
| +3 | K091442 | CD Horizon Spinal System | Medtronic Sofamor Danek | 2009 | — |
| +3 | K091974 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2009 | 1 |
| +4 | K102555 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 7 | 0 |
| 2010 | 3 | 0 |
| 2011 | 6 | 0 |
| 2012 | 21 | 0 |
| 2013 | 33 | 0 |
| 2014 | 37 | 0 |
| 2015 | 40 | 0 |
| 2016 | 42 | 0 |
| 2017 | 46 | 0 |
| 2018 | 54 | 0 |
| 2019 | 44 | 0 |
| 2020 | 60 | 0 |
| 2021 | 56 | 1 |
| 2022 | 69 | 0 |
| 2023 | 86 | 0 |
| 2024 | 77 | 0 |
| 2025 | 71 | 0 |
| 2026 | 65 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042025 | Modification to CD Horizon Spinal SystemSummary page 3…lts, was provided which demonstrated the subject CD HORIZON® AGILETm Dynamic Stabilization Device to be substantially equivalent to predicate CD HIORIZON® Spinal System (K042025, SE 08/25/04), the ATLAS Cable System (K920291, SE 04/08/92), and the DYNESYS® Spinal System cleared in K043565 (SE 03/11/05). =… | 2004 |
| Kept off the family tree | K920291 | FDA’s K920291 is Moni-Trol-L and Moni-Trol-XL Our reading of the summary gave K920291, FDA’s number for Moni-Trol-L and Moni-Trol-XL (Medical Analysis Systems, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “ATLAS Cable System”. Kept off the family tree. Summary page 3…t CD HORIZON® AGILETm Dynamic Stabilization Device to be substantially equivalent to predicate CD HIORIZON® Spinal System (K042025, SE 08/25/04), the ATLAS Cable System (K920291, SE 04/08/92), and the DYNESYS® Spinal System cleared in K043565 (SE 03/11/05). DEPARTMENT OF HEALTH & HUMAN… | 1992 |
| * | K043565 | Modification to Dynesys Spinal SystemSummary page 3…ially equivalent to predicate CD HIORIZON® Spinal System (K042025, SE 08/25/04), the ATLAS Cable System (K920291, SE 04/08/92), and the DYNESYS® Spinal System cleared in K043565 (SE 03/11/05). DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Ser… | 2005 |
What descends from it? (822)
See all 8222 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 12, 2007 | Not classified | Z-1434-2008 | Device Design | Breaks: Shear failure of the cable component of the system. |
| Nov 12, 2007 | Not classified | Z-1431-2008 | Device Design | Breaks: Shear failure of the cable component of the system. |
| Nov 12, 2007 | Not classified | Z-1421-2008 | Device Design | Breaks: Shear failure of the cable component of the system. |
| Nov 12, 2007 | Not classified | Z-1439-2008 | Device Design | Breaks: Shear failure of the cable component of the system. |
| Nov 12, 2007 | Not classified | Z-1414-2008 | Device Design | Breaks: Shear failure of the cable component of the system. |
| Nov 12, 2007 | Not classified | Z-1415-2008 | Device Design | Breaks: Shear failure of the cable component of the system. |
| Nov 12, 2007 | Not classified | Z-1424-2008 | Device Design | Breaks: Shear failure of the cable component of the system. |
| Nov 12, 2007 | Not classified | Z-1419-2008 | Device Design | Breaks: Shear failure of the cable component of the system. |
| Nov 12, 2007 | Not classified | Z-1438-2008 | Device Design | Breaks: Shear failure of the cable component of the system. |
| Nov 12, 2007 | Not classified | Z-1430-2008 | Device Design | Breaks: Shear failure of the cable component of the system. |
| Nov 12, 2007 | Not classified | Z-1433-2008 | Device Design | Breaks: Shear failure of the cable component of the system. |
| Nov 12, 2007 | Not classified | Z-1417-2008 | Device Design | Breaks: Shear failure of the cable component of the system. |
| Nov 12, 2007 | Not classified | Z-1408-2008 | Device Design | Breaks: Shear failure of the cable component of the system. |
| Nov 12, 2007 | Not classified | Z-1412-2008 | Device Design | Breaks: Shear failure of the cable component of the system. |
| Nov 12, 2007 | Not classified | Z-1422-2008 | Device Design | Breaks: Shear failure of the cable component of the system. |
| Nov 12, 2007 | Not classified | Z-1436-2008 | Device Design | Breaks: Shear failure of the cable component of the system. |
| Nov 12, 2007 | Not classified | Z-1423-2008 | Device Design | Breaks: Shear failure of the cable component of the system. |
| Nov 12, 2007 | Not classified | Z-1410-2008 | Device Design | Breaks: Shear failure of the cable component of the system. |
| Nov 12, 2007 | Not classified | Z-1418-2008 | Device Design | Breaks: Shear failure of the cable component of the system. |
| Nov 12, 2007 | Not classified | Z-1435-2008 | Device Design | Breaks: Shear failure of the cable component of the system. |
| Nov 12, 2007 | Not classified | Z-1411-2008 | Device Design | Breaks: Shear failure of the cable component of the system. |
| Nov 12, 2007 | Not classified | Z-1426-2008 | Device Design | Breaks: Shear failure of the cable component of the system. |
| Nov 12, 2007 | Not classified | Z-1416-2008 | Device Design | Breaks: Shear failure of the cable component of the system. |
| Nov 12, 2007 | Not classified | Z-1420-2008 | Device Design | Breaks: Shear failure of the cable component of the system. |
| Nov 12, 2007 | Not classified | Z-1413-2008 | Device Design | Breaks: Shear failure of the cable component of the system. |
| Nov 12, 2007 | Not classified | Z-1428-2008 | Device Design | Breaks: Shear failure of the cable component of the system. |
| Nov 12, 2007 | Not classified | Z-1437-2008 | Device Design | Breaks: Shear failure of the cable component of the system. |
| Nov 12, 2007 | Not classified | Z-1440-2008 | Device Design | Breaks: Shear failure of the cable component of the system. |
| Nov 12, 2007 | Not classified | Z-1409-2008 | Device Design | Breaks: Shear failure of the cable component of the system. |
| Nov 12, 2007 | Not classified | Z-1441-2008 | Device Design | Breaks: Shear failure of the cable component of the system. |
| Nov 12, 2007 | Not classified | Z-1429-2008 | Device Design | Breaks: Shear failure of the cable component of the system. |
| Nov 12, 2007 | Not classified | Z-1425-2008 | Device Design | Breaks: Shear failure of the cable component of the system. |
| Nov 12, 2007 | Not classified | Z-1432-2008 | Device Design | Breaks: Shear failure of the cable component of the system. |
| Nov 12, 2007 | Not classified | Z-1427-2008 | Device Design | Breaks: Shear failure of the cable component of the system. |
The 5 latest of 34 recalls; the web page lists all.
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 · 7 generations on · ◆ in the 2021 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 2 years and passes through 2 companies; a new generation was cleared every 3 months on median.
- 4 of the 13 ancestors have a recall of any class.
- Of its descendants, K063670 (Medtronic Sofamor Danek, 2007) has gone furthest, with 821 descendants of its own.
- 36 other devices also cite its predicate K042025.
How does its category compare?
All NKB devicesNKB Thoracolumbosacral Pedicle Screw System: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 is intended for posterior, non-cervical fixation 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. When used in a…
Read the full statement (696 words)
The CD HORIZON® Spinal System is intended for posterior, non-cervical fixation 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.
When used in a percutaneous, non-cervical, posterior approach with the SEXTANT instrumentation, the CD HORIZON® screws are intended 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; pseudoarthrosis; and/or failed previous fusion.
Except for hooks, when used as an anterolateral thoracic/lumbar system, CD HORIZON® components such as ECLIPSE® components are intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spinal stenosis, (3) spondylolisthesis, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.
The CD HORIZON® SPIRE Plate is a posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (T1 - S1). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: 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); and/or tumor.
The CD HORIZON® LEGACY 3.5mm rod and associated components, when used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, are indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, and/or (7) failed previous fusion (pseudarthrosis).
In addition, when used as a pedicle screw fixation system, the CD HORIZON® LEGACY 3.5mm rod and associated components are indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.
When used as a pedicle screw system in skeletally mature patients, the CD HORIZON® Spinal System PEEK rods and associated components are intended to provided immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities of the thoracic, lumbar and sacral spine: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) kyphosis, and/or (3) failed previous fusion. Additionally, when used as a pedicle screw device, the CD HORIZON® Spinal System PEEK rod constructs are indicated for use in patients who: (1) are receiving fusion with autogenous graft only, (2) are having the device attached to the lumbar or sacral spine, and/or (3) are having the device removed after the development of a solid fusion mass.
When used as a pedicle screw fixation system in skeletally mature patients, the CD HORIZON® AGILE™ Dynamic Stabilization Device is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the degenerative spondylolisthesis with objective evidence of neurologic impairment and/or failed previous fusion in the thoracic, lumbar and/or sacral spine. Additionally, when used as a pedicle screw fixation system, the CD HORIZON® AGILE™ Dynamic Stabilization Device is indicated for use in patients who are receiving fusions with autogenous graft only; who are having the device fixed or attached to the lumbar or sacral spine; and/or are having the device removed after the development of a solid fusion mass.
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 as stated in the FDA summary.
https://510kreport.com/device/K060615 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060615: 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/K060615
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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