# K231145: Axis Anterior Cervical Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Southern Medical (Pty), Ltd.
- Decided: Jun 13, 2023 after 53 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: 7 generations back to K953730 (1995). 41 ancestors in all.
No later device cites it as a predicate yet.
0 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201979: Cervical Plate System, Eminent Spine, LLC (2020) Summary page 5.
- K132994: Anodyne Anterior Cervical Plate System, Corelink, LLC (2013) Summary page 5.

## Indications for use
The Axis Anterior Cervical Plate System is intended for use in skeletally mature patients for anterior screw fixation to the cervical spine (C2-T1) as an adjunct to fusion for the treatment of the following indications: (a) degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); (b) trauma (including fractures); (c) tumours; (d) deformity (defined as kyphosis, lordosis or scoliosis); (e) spondylolisthesis; (f) spinal stenosis; (g) pseudarthrosis and (h) revision of previous surgery.

Source page: https://510kreport.com/device/K231145
Methodology: https://510kreport.com/methodology