# K202820: Australis Anterior Lumbar Cage System

- Pathway: 510(k) (Traditional)
- Applicant: Prism Surgical Designs Pty, Ltd.
- Decided: Dec 22, 2020 after 89 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 25 generations back to K841189 (1984). 485 ancestors in all.
No later device cites it as a predicate yet.
1 of 486 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122639: Synthes Syncage Evolution Spacer, Synthes (USA) Products, LLC (2013) Summary page 5.
- K172349: InFill® Interbody Fusion Device, Pinnacle Spine Group, LLC (2017) Summary page 5.
- K200541: Hive™ Stand-alone Anterior Lumbar Interbody System, Hd Lifesciences, LLC (2020) Summary page 5.
- K183705: IdentiTi Porous Ti Interbody System, Alphatec Spine, Inc. (2019) Summary page 5.
- K200352: Axis Spine Technologies ALIF, Axis Spine Technologies, Ltd. (2020) Summary page 5.

## Indications for use
The Australis Spinal System is indicated for use as lumbar intervertebral body fusion devices for spinal fusion procedures in skeletally mature patients with symptomatic degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. The Australis Spinal System is intended to be used with autograft and/or allograft bone graft material comprised of cancellous and/or corticocancellous bone graft. Patients receiving the device should have had at least six months of nonoperative treatment prior to receiving the Australis ALIF cage. The Australis Spinal System is indended for use with supplemental fixation, such as the Prism Surgical Aurora® Anterior Lumbar Plate System.

Source page: https://510kreport.com/device/K202820
Methodology: https://510kreport.com/methodology