# K032033: CD Horizon Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Sofamor Danek
- Decided: Sep 12, 2003 after 73 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
No predicates in its family tree.
1,106 later devices descend from it; 7 cite it directly.
1 of 1,107 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) TSRH Spinal System: named in the summary without a submission number
- (no number) CD 8 Spinal System: named in the summary without a submission number
- (no number) TOWNLEY Plating System: named in the summary without a submission number

## Most influential descendants
- K050809: CD Horizon Spinal System (2005), 870 descendants of its own
- K063670: Modifications to CD Horizon Spinal System (2007), 821 descendants of its own
- K052187: Modification to:  CD Horizon Spinal System (2005), 780 descendants of its own
- K082236: CD Horizon Spinal System (2008), 779 descendants of its own
- K053101: CD Horizon Spinal System (2006), 778 descendants of its own

## Indications for use
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 IHORIZON@ cannulated 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; pseudaarthrosis; 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. In order to achieve additional levels of fixation, the CD HORIZONB Spinal System rods may be connected to the VERTEXTM Reconstruction System with the VERTEXTM rod connector. Refer to the VERTEXTM Reconstruction System Package Insert for a list of the VERTEXTM indications of use.

Source page: https://510kreport.com/device/K032033
Methodology: https://510kreport.com/methodology