# K031888: Modification to CD Horizon Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek
- Decided: Jun 27, 2003 after 9 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- 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.
11 later devices descend from it; 1 cites it directly.
0 of 12 devices in its family (counting itself) have 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
- K153589: CD HORIZON Spinal System (2016), 10 descendants of its own
- K161842: Overwatch Spine System (2016), 6 descendants of its own
- K191576: Mercury® Spinal System, Overwatch® Spinal System (2019), 5 descendants of its own
- K222516: Mercury® II Spinal System (2022), 3 descendants of its own
- K243916: Primus Spinal Fixation System (2025), 2 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 non-cervical 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-S1) vertebral joint; (b) 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, non-cervical, 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 HORIZON@ 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-S1) 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. (1.e. degenerative scoliosis, kyphosis, and/or lordosis), (5) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion. The CD HORIZON@ ECLIPSE@ components arc intended for the following indications:. When used as an anterolateral thoracic/lumbar system, the CD HORIZONB 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, 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 VERTEXT" Reconstruction System with the VERTEXTMrod connector. When connecting to the VERTEXTMReconstruction 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, (C 1-T3), the VERTEXT" 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 andor 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 cervical/upper thoracic (C 1-T3) spine. Multi-axial Screws/Lateral Connectors The use of VERTEXTMmulti-axial screws (3.5mm 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 ATLAST" Cable and the CD HOEUZONB Spinal System may be used with the VERTEXThI Reconstruction System.

Source page: https://510kreport.com/device/K031888
Methodology: https://510kreport.com/methodology