510(k) · Cleared
ClearedModification to CD 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 Nov 6, 2006 as substantially equivalent to K010249 (Medtronic Sofamor Danek, Inc., 2001) and 3 other predicates after a 27-day review. Its family tree reaches back 7 generations to 2004.
- Decided
- Nov 6, 2006
- Review
- 27 days
- Class
- Class II
- Product code
- NKB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K040583 (2004). 36 ancestors in all, the oldest K841189 (1984). No later device cites it as a predicate yet.
- Root · 7 generations backK040583 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 6 generations backK041118 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek · 2004
- 5 generations backK042025 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2004 · Recalled
- 4 generations backK043151 Modification to: CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- 3 generations backK050809 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 2 generations backK051674 CD Horizon Spinal SystemMedtronic Sofamor Danek USA, Inc. · 2005
- 1 generation backK052747 Modification to:CD Horizon Spinal SystemMedtronic Sofamor Danek · 2005
- This deviceK063083 Modification to CD Horizon Spinal SystemMedtronic Sofamor Danek, Inc. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K040583 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −6 | K041118 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek | 2004 | — |
| −5 | K042025 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2004 | 4 |
| −4 | K043151 | Modification to: CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| −3 | K050809 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −2 | K051674 | CD Horizon Spinal System | Medtronic Sofamor Danek USA, Inc. | 2005 | — |
| −1 | K052747 | Modification to:CD Horizon Spinal System | Medtronic Sofamor Danek | 2005 | — |
| 0 (this device) | K063083 | Modification to CD Horizon Spinal System | Medtronic Sofamor Danek, Inc. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 5 | 0 |
| 2001 | 5 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2004 | 9 | 0 |
| 2005 | 1 | 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? (4)
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 |
|---|---|---|---|
| * | K010249 | CD Horizon Spinal SystemSummary page 2…ysis, was provided which demonstrated the subject staples and screws are substantially equivalent to similar CD HORIZON® Spinal System components cleared previously in KG010249, K052747 and K042025 (SE 02/23/01, 10/28/05 and 08/25/04 respectively) as well as TSRI-I® Spinal System components cleared for us… | 2001 |
| * | K052747 | Modification to:CD Horizon Spinal SystemSummary page 2…s provided which demonstrated the subject staples and screws are substantially equivalent to similar CD HORIZON® Spinal System components cleared previously in KG010249, K052747 and K042025 (SE 02/23/01, 10/28/05 and 08/25/04 respectively) as well as TSRI-I® Spinal System components cleared for use in the… | 2005 |
| * | K042025 | Modification to CD Horizon Spinal SystemSummary page 2…hich demonstrated the subject staples and screws are substantially equivalent to similar CD HORIZON® Spinal System components cleared previously in KG010249, K052747 and K042025 (SE 02/23/01, 10/28/05 and 08/25/04 respectively) as well as TSRI-I® Spinal System components cleared for use in the CD HORIZON®… | 2004 |
| * | K981676 | CD Horizon Spinal SystemSummary page 2…49, K052747 and K042025 (SE 02/23/01, 10/28/05 and 08/25/04 respectively) as well as TSRI-I® Spinal System components cleared for use in the CD HORIZON® Spinal System in K981676 (01/28/99). DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Serv… | 1999 |
What descends from it?
No later submission names this one as a predicate yet.
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 2 years and passes through 3 companies; a new generation was cleared every 3 months on median.
- 3 of the 36 ancestors have a recall of any class.
- 1 other device also cites its predicate K010249.
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 with or without SEXTENT® instrumentation 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; pseudarthritis…
Read the full statement (214 words)
The CD HORIZON® Spinal System with or without SEXTENT® instrumentation 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; pseudarthritis; 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.
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.
The CD HORIZON® SPIRE Plate is a posterior, non-pedicle supplemental fixation device intended for use in the non-cervical spine (TI-S 1). It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion 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 VERTEXTM Reconstruction System with the VERTEXTM rod connector. Refer to the VERTEXrm Reconstruction System Package Insert for a list of the VERTEXTm indications of use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063083 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063083: Modification to 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/K063083
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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