# K033148: Art Anterior Spinal System

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Medical Technologies AG
- Decided: Apr 12, 2004 after 195 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: 2 generations back to K873826 (1988). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971248: Kaneda SR Anterior Spinal System, Acromed Corp. (1997) Summary page 1.
- K972718: M-2 Anterior Plate System, Acromed Corp. (1997) Summary page 1.

## Indications for use
The ART Anterior Spinal System is intended for anterolateral screw fixation of the T6-L5 spine. Indications for use include: · degenerative disc disease (ddd) defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies * spondylolisthesis * trauma (i.e., fracture or dislocation) · spinal stenosis · deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) * tumor · pseudoarthrosis · failed previous fusion

Source page: https://510kreport.com/device/K033148
Methodology: https://510kreport.com/methodology