# K962708: Titanium CD Horizon Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Sofamor Danek USA,Inc.
- Decided: Feb 6, 1997 after 209 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.
254 later devices descend from it; 3 cite it directly.
0 of 255 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
- 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 Titanium CD HORIZON™ Spinal System, when using screws for pedicle fixation, is 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. Except for situations where screws are attached to the pedicles of the [umbar and sacral spine via a posterior surgical spproach in a Titanium CD HORIZON™ construct for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the L5-S1 vertebral joint, the specific indications for the Titanium 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, lordosis Fracture Unsuccessful previous attempts at spinal fusion Tumor resection NOTA BENE: The Titanium CD HORIZON™ Semal System Is limited to hon-cervical use. The titanium alioy CD HORIZON™ screws and the titanium alloy TSRH® Variable Angle Screws, when used as pedicle screws with the Titanium 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 pedicie screw fixation as described above, the screws are indicated only for insertion no higher than L3 and not lower than the sacrum. Otherwise the titanium alloy CD HORIZON™ screws and the titanium alloy TSRH® Variable Angle Scraws, when used with the Titanium CD HORIZON™ Spinal System, are intended for sacral/iliac attachment only. All of the titanium alloy CD HORIZON™ hooks are intended for thoracic and/or lumbar attachwnent only. The titanium alloy TSRH® Low Profile CROSSLINK® Offset Plate, the titanium alloy TSRH® Low Profile CROSSLINK® plates, and the titanium alloy CD HORIZON™ Low Profile MULTI-SPAN™ CROSSLINK® plates are intended for posterior thoracic, lumbar, and/or sacral use only.

Source page: https://510kreport.com/device/K962708
Methodology: https://510kreport.com/methodology