# K042025: Modification to CD Horizon Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek, Inc.
- Decided: Aug 25, 2004 after 28 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K040583 (2004). 9 ancestors in all.
987 later devices descend from it; 37 cite it directly.
1 of 997 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040583: Modification to: CD Horizon Spinal System, Medtronic Sofamor Danek (2004) Summary page 2.
- K020709: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek (2002) Summary page 2.
- K031655: CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2003) Summary page 2.
- K041118: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek (2004) Summary page 2.
- K032265: CD Horizon Spinal System, Medtronic Sofamor Danek (2003) Summary page 2.
- K000094: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek USA, Inc. (2000) Summary page 2.
- K034056: Modification to CD Horizon Spinal System, Medtronic Sofamor Danek (2004) Summary page 2.
- K981676: CD Horizon Spinal System, Sofamor Danek USA,Inc. (1999) Summary page 2.
- K001532: Dyna-Lok Classic Spinal System, Medtronic Sofamor Danek, Inc. (2000)

## Most influential descendants
- K043151: Modification to: CD Horizon Spinal System (2005), 880 descendants of its own
- K050809: CD Horizon Spinal System (2005), 870 descendants of its own
- K060615: CD Horizon Spinal System (2006), 822 descendants of its own
- K063670: Modifications to CD Horizon Spinal System (2007), 821 descendants of its own
- K052054: TSRH Spinal System (2005), 786 descendants of its own

## Recalls of this device
- Nov 30, 2011 · Not classified · Z-0464-2012: One screw may be longer then size etched on the screw.
- Nov 30, 2011 · Not classified · Z-0465-2012: One screw may be longer then size etched on the screw.
- Jun 28, 2011 · Not classified · Z-2878-2011: Screws are longer then size etched on the screw.
- Jun 28, 2011 · Not classified · Z-2875-2011: Screws are longer then size etched on the screw.

## 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 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 HORIZON® 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; pseudoarthrosis; and/or failed previous fusion. Except for hooks, when used as an anterolateral thoracic/lumbar system, CD 1tORIZONO 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. The CD HORIZON® SPIRE Plate is posterior, non-pedicle supplemental fixation device, intended for use in the non-cervical spine (TI - SI). It is intended for plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: 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); 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 VERTEXTM Reconstruction System Package Insert for a list of the VERTEXTM indications of use.

Source page: https://510kreport.com/device/K042025
Methodology: https://510kreport.com/methodology