# K063083: Modification to CD Horizon Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Nov 6, 2006 after 27 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: 7 generations back to K040583 (2004). 36 ancestors in all.
No later device cites it as a predicate yet.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010249: CD Horizon Spinal System, Medtronic Sofamor Danek, Inc. (2001) Summary page 2.
- K052747: Modification to:CD Horizon Spinal System, Medtronic Sofamor Danek (2005) Summary page 2.
- K042025: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek, Inc. (2004) Summary page 2.
- K981676: CD Horizon Spinal System, Sofamor Danek USA,Inc. (1999) Summary page 2.

## Indications for use
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.

Source page: https://510kreport.com/device/K063083
Methodology: https://510kreport.com/methodology