# K101074: Modification to: CD Horizon (R) Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Jun 22, 2010 after 64 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K981676 (1999). 15 ancestors in all.
225 later devices descend from it; 3 cite it directly.
0 of 241 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981676: CD Horizon Spinal System, Sofamor Danek USA,Inc. (1999) Summary page 3.
- K040962: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek (2004) Summary page 3.
- K050981: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2005) Summary page 3.
- K090390: CD Horizon Spinal System, Medtronic Sofamor Danek (2009) Summary page 3.
- K052144: TSRH Spinal System, Medtronic Sofamor Danek (2005) Summary page 3.

## Most influential descendants
- K132328: CD Horizon Spinal System (2013), 176 descendants of its own
- K140276: CD Horizon Spinal System (2014), 85 descendants of its own
- K142381: Xia 3 Spinal System (2014), 83 descendants of its own
- K140449: CD Horizon Spinal System (2014), 59 descendants of its own
- K182119: CD HORIZON™ Spinal System (2018), 58 descendants of its own

## Indications for use
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 hack 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® LEGACYTm 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 CD HORIZON SPIRETM 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. 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 as an adjunct to fusion, 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.

Source page: https://510kreport.com/device/K101074
Methodology: https://510kreport.com/methodology