# K201079: Aurora® Anterior Lumbar Plate Sytstem

- Pathway: 510(k) (Traditional)
- Applicant: Prism Surgical Design Pty, Ltd.
- Decided: Aug 5, 2020 after 105 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: 5 generations back to K922543 (1993). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052546: Aegis Anterior Lumbar Plate System, Depuy Spine, Inc. (2006) Summary page 5.
- K080429: Modificaton to: Pyramid +4 Anterior Lumbar Plate System, Medtronic Sofamor Danek USA, Inc. (2008) Summary page 5.

## Indications for use
The Aurora® Anterior Lumbar Plate System is indicated for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels or via the anterior surgical approach, below the bifurcation of the great vessels as an adjunct to fusion. The AURORA® Anterior Lumbar Plate System is indicated for in the treatment of lumbar and lumbosacral (L1-S1) spinal instability as a result of the following; x degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies) x spondylolisthesis x trauma (i.e., fracture or dislocation) x spinal stenosis x deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) x tumor x pseudoarthrosis x failed previous fusion This device is not intended for screw attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.

Source page: https://510kreport.com/device/K201079
Methodology: https://510kreport.com/methodology