# K955365: Compact Cotrel-Dubousset (CCD) Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Sofamor Danek USA,Inc.
- Decided: Mar 27, 1996 after 126 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The CCD™ Spinal System is limited to non-cervical use in the posterior spine. The CCD spinal screws, when used as pedicle screws with the CCD™ Spinal System, are intended only for patients: (a) having severe spondylolisthesis (grade 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 no lower than the sacrum. Otherwise, the CCD screws, when used in posterior fixation, are intended for sacral/iliac attachment only. Except for situations where stainless steel screws are attached to the pedicles of the lumbar and sacral spine via a posterior surgical approach in a CCD construct for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the L5-S1 vertebral joint, the specific indications for the CCD Spinal System (either stainless steel or titanium alloy versions) are the following: Degenerative disc disease (as defined by instability in the presence of one or more of the following: osteophyte formation, decrease in disc space height, endplate sclerosis, disc herniations, facet joint changes, and scarring and/or thickening of the annulus fibrosis, ligamentum flavum, or facet joint capsule). Pseudoarthrosis Stenosis Spondylolisthesis Spinal deformities: scoliosis, kyphosis, and lordosis Fracture Unsuccessful previous attempts at spinal fusion Tumor resection All of the CCD hooks are intended for posterior thoracic and/or lumbar use only. CCD cross connectors are intended for posterior thoracic, lumbar, and/or sacral use only.

Source page: https://510kreport.com/device/K955365
Methodology: https://510kreport.com/methodology