# K961633: CD Horizon Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Sofamor Danek USA,Inc.
- Decided: Dec 5, 1996 after 220 days
- Product code: KWP (Appliance, Fixation, Spinal Interlaminal)
- Device class: 2
- Regulation: 21 CFR 888.3050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
379 later devices descend from it; 11 cite it directly.
1 of 380 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
- K982914: Aesculap Spine System Evolution: Additional Components (1998), 251 descendants of its own
- K980484: Aesculap Spine System Evolution (1998), 251 descendants of its own
- K990118: Isobar Spinal System (1999), 250 descendants of its own
- K061162: Bar Pedicle Screw Spinal Fixation System, Model 2020 (2006), 131 descendants of its own
- K092624: Firebird Spinal Fixation System (2009), 130 descendants of its own

## Indications for use
The CD HORIZON™ Spinal System is intended to provide temporary stabilization and to help augment the development of a solid spinal fusion. Except for situations using pedicle screws in 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); and (d) who are having the device removed after the development of a solid fusion mass, the specific indications for the CD HORIZON™ Spinal System are the following: 1. 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, and lordosis Fracture Unsuccessful previous attempts at spinal fusion Tumor resection The CD HORIZON™ Spinal System is intended for use only in the thoracic, lumbar, and/or sacral levels of the posterior spine. The CD HORIZON™ Spinal System is limited to non-cervical use. The CD HORIZON™ Screws, TSRH® Variable Angle Screws, LIBERTY® screws, and/or DYNA-LOK® bolts, when used as pedicle screws with the CD HORIZON™ Spinal System, are intended only for 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; and (d) who are having the device removed after the development of a solid fusion mass. When used for pedicle screw fixation as described above, the screws are indicated only for insertion no higher than L3 and not lower than the sacrum. Otherwise the CD HORIZON™ screws, TSRH® Variable Angle Screws, LIBERTY® screws, and/or DYNA-LOK® bolts, when used with the CD HORIZON™ Spinal System, are intended for sacroiliac attachment only. The CCD™ Screw for Sacral Block and CCD™ Conical Fixation Screws are intended for sacroiliac attachment only. All of the CD HORIZON™ hooks are intended for thoracic and/or lumbar attachment only. GDLH™ CROSSLINK® Bars, CD HORIZON™ Low Profile CROSSLINK® plates, and TSRH® CROSSLINK® plates are intended for posterior thoracic, lumbar, and/or sacral use only.

Source page: https://510kreport.com/device/K961633
Methodology: https://510kreport.com/methodology