# K964159: CD Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Sofamor Danek USA,Inc.
- Decided: Oct 16, 1997 after 365 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.
281 later devices descend from it; 4 cite it directly.
0 of 282 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
- 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
- K100044: Firebird Spinal Fixation System, Firebird Side-Loading Body (2010), 117 descendants of its own

## Indications for use
When used as a pedicle screw fixation system with CD screws attached to the non-cervical posterior spine, the CD Spinal System is indicated for degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies). When used as a pedicle screw fixation system, the CD Spinal System is also indicated for Grade III and IV spondylolisthesis. For this indication only, the spondylolisthesis must be at L5-S1 in patients who are receiving fusions using autogenous bone graft only and who are having the device removed after the development of a solid fusion mass. Although the levels of fusion may not go above the L5-S1 joint for these severe spondylolisthesis cases, the levels of pedicle screw fixation may be L3 to the sacrum. When used as a posterior non-pedicle screw fixation system, the CD Spinal System is intended for the indications given above as well as spinal stenosis, spondylolisthesis, spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), fracture, pseudarthrosis, tumor resection, and unsuccessful previous attempts at spinal fusion. For non-pedicle screw use, the levels of fixation for the CD Spinal System are T1 to sacrum, with the screws limited to sacral fixation.

Source page: https://510kreport.com/device/K964159
Methodology: https://510kreport.com/methodology