# K955807: Cotrel-Dubousset (CD) Spinal

- Pathway: 510(k) (Traditional)
- Applicant: Sofamor Danek USA,Inc.
- Decided: Oct 1, 1996 after 284 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.
15 later devices descend from it; 1 cites it directly.
0 of 16 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
- K031595: U & I America Spinal Hook System (2003), 14 descendants of its own
- K113324: Rexious Hook Fixation Systems (2012), 6 descendants of its own
- K123476: Mega 5.5 Spine System (2013), 5 descendants of its own
- K171497: Mikron Spinal Fixation System (2017), 4 descendants of its own
- K241657: MSFX Mikron Spinal Fixation System (2024), 3 descendants of its own

## Indications for use
The CD™ Spinal System is limited to non-cervical use in the posterior spine. The CD spinal screws, when used as pedicle screws with the CD™ 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. Otherwise, the CD 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 CD construct for the treatment of severe spondylolisthesis (Grade 3 and Grade 4) at the L5-S1 vertebral joint, the specific indications for the CD Spinal System (either stainless steel or titanium alloy versions) are the following: 1. Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by radiographic studies). 2. Pseudoarthrosis Unsuccessful previous attempts at spinal fusion Tumor resection 3. Stenosis 4. Spondylolisthesis 5. Spinal deformities: scoliosis, kyphosis, and lordosis 6. Fracture All of the CD hooks are intended for posterior thoracic and/or lumbar use only. CD cross connectors are intended for posterior thoracic, lumbar, and/or sacral use only.

Source page: https://510kreport.com/device/K955807
Methodology: https://510kreport.com/methodology