# K963655: CD Horizon Anterior Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Sofamor Danek USA,Inc.
- Decided: Nov 27, 1996 after 76 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.
777 later devices descend from it; 3 cite it directly.
1 of 778 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
- K091442: CD Horizon Spinal System (2009), 776 descendants of its own
- K091974: Modification to CD Horizon Spinal System (2009), 656 descendants of its own
- 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

## Indications for use
The CD HORIZON™ Anterior Spinal System is designed to aid in the surgical correction and stabilization of the spine. The system is intended to assist stabilization until a solid spinal fusion develops. The specific indications for the CD HORIZON™ Anterior Spinal System are the following: Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). Pseudoarthrosis Stenosis Spondylolisthesis Spinal deformities: scoliosis, kyphosis, lordosis Fracture Unsuccessful previous attempts at spinal fusion Tumor resection All components of the CD HORIZON™ Anterior Spinal System are intended to be fixed/attached to the anterolateral spine by screws/staples in the thoracic and/or lumbar areas only.

Source page: https://510kreport.com/device/K963655
Methodology: https://510kreport.com/methodology