# K091974: Modification to CD Horizon Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek USA, Inc.
- Decided: Sep 2, 2009 after 63 days
- Product code: NKB (Thoracolumbosacral Pedicle Screw System)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K040583 (2004). 57 ancestors in all.
656 later devices descend from it; 18 cite it directly.
1 of 714 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042025: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek, Inc. (2004) Summary page 2.
- K030840: Modification to Horizon Spinal System, Medtronic Sofamor Danek, Inc. (2003) Summary page 2.
- K031655: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2003) Summary page 2.
- K032265: CD Horizon Spinal System, Medtronic Sofamor Danek (2003) Summary page 2.
- K033322: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek (2003) Summary page 2.
- K042167: Modification to: CD Horizon Spinal System, Medtronic Sofamor Danek (2004) Summary page 2.
- K043488: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek (2005) Summary page 2.
- K050439: CD Horizon Spinal System, Medtronic Sofamor Danek, Inc. (2005) Summary page 2.
- K050809: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2005) Summary page 2.
- K053474: CD Horizon Spinal System, Medtronic Sofamor Danek (2006) Summary page 2.
- K061579: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek (2006) Summary page 2.
- K061591: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek, Inc. (2006) Summary page 2.
- K082236: CD Horizon Spinal System, Medtronic Sofamor Danek (2008) Summary page 2.
- K090390: CD Horizon Spinal System, Medtronic Sofamor Danek (2009) Summary page 2.
- K091442: CD Horizon Spinal System, Medtronic Sofamor Danek (2009). Cleared while this submission was under review Summary page 2.
- K052054: TSRH Spinal System, Medtronic Sofamor Danek (2005) Summary page 2.

## Most influential descendants
- K102555: CD Horizon Spinal System (2010), 598 descendants of its own
- K112473: CD Horizon Spinal System (2011), 597 descendants of its own
- K112555: CD Horizon (R) Spinal System (2011), 597 descendants of its own
- K113174: CD Horizon Spinal System (2011), 596 descendants of its own
- K102807: CD Horizon Spinal System (2010), 517 descendants of its own

## Recalls of this device
- Jun 28, 2011 · Not classified · Z-2876-2011: Screws are longer then size etched on the screw.

## 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 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 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, non-pedicle supplemental fixation device intended for use in the non-cervical spine (TI-S 1) 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/K091974
Methodology: https://510kreport.com/methodology