# K063417: Modification to CD Horizon Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek
- Decided: Jan 18, 2007 after 66 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: 6 generations back to K040583 (2004). 33 ancestors in all.
576 later devices descend from it; 3 cite it directly.
1 of 610 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051674: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2005) Summary page 2.

## Most influential descendants
- K102807: CD Horizon Spinal System (2010), 517 descendants of its own
- K121680: CD Horizon Spinal System (2012), 357 descendants of its own
- K113395: Revere 4.5 Stabilization System (2012), 260 descendants of its own
- K132639: CD Horizon Spinal System (2013), 243 descendants of its own
- K122226: Revere Stabilization System (2012), 225 descendants of its own

## Indications for use
The CD HORIZON® Spinal System with or without SEXTANT® 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 (T1-S1). 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. When used as a pedicle screw fixation system in skeletally mature patients, the CD HORIZON® AGILETM Dynamic Stabilization device is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of the degenerative spondylolisthesis with objective evidence of neurologic impairment and/or failed previous fusion in the thoracic, lumbar and/or sacral spine. Additionally, when used as a pedicle screw fixation system, the CD HORIZON® AGILETM Dynamic Stabilization device is indicated for use in patients who are receiving fusions with autogenous graft only; who are having the device fixed or attached to the lumbar or sacral spine; and/or are having the device removed after the development of a solid fusion mass. In order to achieve additional levels of fixation, the CD HORIZON® Spinal System rods may be connected to the VERTEX TM 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/K063417
Methodology: https://510kreport.com/methodology