# K032265: CD Horizon Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek
- Decided: Aug 11, 2003 after 19 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1,192 later devices descend from it; 10 cite it directly.
1 of 1,193 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 no predicate by number.

## Most influential descendants
- K041777: Modification to CD Horizon Spinal System (2004), 1,130 descendants of its own
- K043488: Modification to CD Horizon Spinal System (2005), 1,128 descendants of its own
- K042025: Modification to CD Horizon Spinal System (2004), 987 descendants of its own
- K043151: Modification to: CD Horizon Spinal System (2005), 880 descendants of its own
- K050809: CD Horizon Spinal System (2005), 870 descendants of its own

## Indications for use
The CD HORIZON@system is intended for the following indications: When used as a pedicle screw fixation system of the noncenical posterior spine in skeletally mature patients, the CD HORIZON@ Spinal System is indicated for one or more of the following: (1) degenerative spondylolisthesis with objective evidence of neurologic impairment, (2) fracture, (3) dislocation, (4) scoliosis, (5) kyphosis, (6) spinal tumor, andor (7) failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the CD HORIZON@ Spinal System is indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S 1) vertebral joint; @) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4)who are having the device removed after the development of a solid fusion mass. When used as a posterior, noncervical, non-pedicle screw fixation system, the CD HORIZON@ Spinal System is 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, andor lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, andor (8) failed previous fusion. When used in a percutaneous posterior approach with the SEXTANT instrumentation, the CD HORIZON@ Cannulated M8 Multi-Axial Screw components are intended for the following indications: When used as a pedicle screw fixation system the CD HORIZON0 Cannulated M8 Multi-Axial Screw components are indicated for skeletally mature patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S 1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); (d) who are having the device removed after the development of a solid fusion mass. In addition, when used as a posterior spine thoracicAumbar system, the CD HORIZON@ Cannulated M8 Multi-Axial Screw components are intended for: (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. degenerative scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, andor (8) failed previous fusion. The CD HORIZON0 ECLIPSE0 components are intended for the following indications: When used as an anterolateral thoracichmbar system, the CD HORIZON0 Spinal System is 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 (Le., scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, andor (8) failed previous fusion. In order to achieve additional levels of fixation, the CD HORIZON@ Spinal System rods may be connected to the VERTEXTM Reconstruction System with the V E R T E F rod copnector. When connecting to the VERTEXm Reconstruction System in the cervical spine, components are intended for the following indications: When intended to promote fusion of the cervical spine and the thoracic spine, (Cl-T3), the VERTEXm Reconstruction System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. Hooks and Rods The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervicaVupper thoracic (C1-T3) spine. Multi-axial ScrewsLateral Connectors The use of VERTEXTMrxulti-axial screws (3.5~ and 4.0mm cancellous, and 4.0mm cortical) is limited to placement in Tl-T3 in treating thoracic conditions only. The multi-axial screws are not intended to be placed in the cervical spine. Titanium ATLASm Cable and the CD HORIZON@ Spinal System may be used with the VERTEXTMReconstruction System.

Source page: https://510kreport.com/device/K032265
Methodology: https://510kreport.com/methodology