# K063764: Southern Spine Anterior Cervical Stabilization System, Kwik- Fix Cervical System, and Kwik-Fix / TS Cervical System

- Pathway: 510(k) (Special)
- Applicant: Southern Spine, LLC
- Decided: May 16, 2007 after 147 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
Longest line of descent: 1 generation back to K021979 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021979: Smisson Stabilization System, Smisson-Cartledge (2003) Summary page 1.

## Indications for use
The Southern Spine Anterior Cervical Stabilization System (SSACSS) 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 degeneration 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), pseudoarthrosis, 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/K063764
Methodology: https://510kreport.com/methodology