# K092325: Modification to:CD Horizon Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Dec 15, 2009 after 133 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: 8 generations back to K040583 (2004). 42 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091442: CD Horizon Spinal System, Medtronic Sofamor Danek (2009) Summary page 3.
- K032037: CD Horizon (Addition of Spinous Process Plate), Medtronic Sofamor Danek (2003) Summary page 3.

## Most influential descendants
- K123246: CD Horizon Spire Z Spinal System (2012), 2 descendants of its own
- K160465: Spinal Elements' Spinous Process Plate System (2016), 0 descendants of its own
- K132765: PFX Spinous Process Fixation System (2014), 0 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 back pain of discogenric 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 as an adjunct to fusion. With the exception of degenerative disc disease, the CD HORIZON® LEGACYTm 3.5mmn 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 SPIIRETm Plate is a posterior, single level, non-pedicle supplemental fixation device intended for use in the non-cervical spine (T7I -SI) as an adjunct to fusion. It is intended for plate fixation/attachment to spinous processes for the purpose of achieving supplemental fusion mn the following conditions: degenerative disc disease (as previously defined); spondylo-listhesis, trauma; and/or tumor. In order to achieve additional levels of fixation as an adjunct to fusion, the CD HORIZON® Spinal Systemn 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/K092325
Methodology: https://510kreport.com/methodology