# K980184: CD Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Sofamor Danek USA,Inc.
- Decided: Dec 18, 1998 after 332 days
- Product code: MNI (Orthosis, Spinal Pedicle Fixation)
- Device class: 2
- Regulation: 21 CFR 888.3070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
68 later devices descend from it; 1 cites it directly.
0 of 69 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
- K133746: Polaris Spinal System (2014), 67 descendants of its own
- K143248: Reform Pedicle Screw System (2014), 30 descendants of its own
- K150856: Reform Pedicle Screw System (2015), 26 descendants of its own
- K173130: Reform® Midline Cortical Screw System (2017), 21 descendants of its own
- K150896: Vitality Spinal Fixation System (2015), 19 descendants of its own

## Indications for use
When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients, the CD™ Spinal System is indicated for one or more of 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), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, (5) scoliosis, (6) kyphosis, (7) spinal tumor, and/or (8) failed previous fusion (pseudarthrosis). In addition, when used as a pedicle screw fixation system, the CD ™ Spinal System is indicated for skeletally mature patients: (1) having severe spondylolisthesis (Grades 3 and 4) of the fith lumbar-first sacral (L5-S1) vertebral joint; (2) who are receiving fusions using autogenous bone graft only; (3) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (4) who are having the device removed afier the development of a solid fusion mass. When used as a posterior, non-cervical, non-pedicle screw fixation system, the CD™ Spinal System is intended for the following indications: (1) degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) spondylolisthesis, (3) fracture, (4) spinal deformities (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) pseudarthrosis, (7) tumor resection, and/or (8) failed previous fusion.

Source page: https://510kreport.com/device/K980184
Methodology: https://510kreport.com/methodology