# K021979: Smisson Stabilization System

- Pathway: 510(k) (Traditional)
- Applicant: Smisson-Cartledge
- Decided: Jun 27, 2003 after 375 days
- Product code: KWQ (Appliance, Fixation, Spinal Intervertebral Body)
- Device class: 2
- Regulation: 21 CFR 888.3060
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K063764: Southern Spine Anterior Cervical Stabilization System, Kwik- Fix Cervical System, and Kwik-Fix / TS Cervical System (2007), 0 descendants of its own

## Indications for use
The Smisson Stabilization System is intended for anterior interbody screw fixation of the cervical spine. The system is indicated for use in the temporary stabilization of the anterior spine (C2-TI) during the development of cervical spine fusions in patients with degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (defined as kyphosis, lordosis, or scoliosis), pseudarthrosis, and/or failed previous fusions. “Warning: This device is not approved for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic, or lumbar spine.”

Source page: https://510kreport.com/device/K021979
Methodology: https://510kreport.com/methodology