# K031833: Modification to CD Horizon Spinal System

- Pathway: 510(k) (Special)
- Applicant: Medtronic Sofamor Danek
- Decided: Sep 3, 2003 after 82 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.
49 later devices descend from it; 2 cite it directly.
0 of 50 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 its predicate without a number.
- (no number) CD HORIZON Spinal System: named in the summary without a submission number

## Most influential descendants
- K162379: CD HORIZON® Spinal System (2016), 45 descendants of its own
- K223494: CD Horizon Spinal System (2023), 17 descendants of its own
- K163375: INFINITY™ OCT System (2017), 16 descendants of its own
- K181139: OLYMPIC Posterior Spinal Fixation System (2018), 8 descendants of its own
- K180851: VERTEX™ Reconstruction System (2018), 8 descendants of its own

## Indications for use
The CD HORIZONB 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 HORIZONB 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, and/or (7) failed previous fusion (pseudarthrosis). I n 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 (LS-SI) vertebral joint; (b) wlio are receiving fusions using autogenous bone graft only; ( 3 ) wlio 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, iion-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, and/or lordosis), ( 5 ) fracture, ( 6 ) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion. SEXTANT Instrumentation 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. In addition, when used as a posterior spine thoracic/lumbar 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, and/or (8) failed previous fusion. CD HOFUZONB ECLIPSEB The CD HORIZON@ ECLIPSE@ components are intended for the following indications: When used as an anterolateral thoracicllumbar 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, and/or lordosis), ( 5 ) fracture, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion. CD HORIZON@ Spinal System connected to VERTEXTMReconstruction System In order to achieve additional levels of fixation, the CD HORIZON@ Spinal System rods may be connected to the VERTEXTMReconstruction System with the ERTEXTM rod 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 VERTEXTMReconstruction 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 cervical/upper thoracic (C 1-T3) spine. Multi-axial ScrewdLateral Connectors The use of VERTEXTMmulti-axial screws (3.5mm and 4.0mm cancellous, and 4.0mm cortical) is limited to placement in T1-T3 in treating thoracic conditions only. The multi-axial screws are not intended to be placed in the cervical spine. Titanium ATLASTMCable and the CD HORIZON@ Spinal System may be used with the VERTEXTMReconstruction System.

Source page: https://510kreport.com/device/K031833
Methodology: https://510kreport.com/methodology