# K172019: Brisbane ALIF Device, Gladstone ALIF Device

- Pathway: 510(k) (Traditional)
- Applicant: Signature Orthopaedics Pty, Ltd.
- Decided: Nov 29, 2017 after 147 days
- Product code: OVD (Intervertebral Fusion Device With Integrated Fixation, 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: 16 generations back to K841189 (1984). 179 ancestors in all.
No later device cites it as a predicate yet.
0 of 180 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141942: Midline II TI, Centinel Spine, Inc. (2014) Summary page 4.
- K142023: Luna Interbody System, Benvenue Medical, Inc. (2014) Summary page 4.
- K133494: Chesapeake Spinal System, K2m, Inc. (2014) Summary page 4.
- K081888: Dynamik Intervertebral Body Fusion Device, Spineart (2009) Summary page 4.
- K163625: NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate System, Signature Orthopaedics Pty, Ltd. (2017). Cleared while this submission was under review Summary page 4.

## Indications for use
The Signature Orthopaedics Brisbane ALIF and Gladstone ALIF systems are indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of nonoperative treatment. Patients with previous non-fusion spinal surgery at the treated level may be treated. These implants may be implanted via a laparoscopic or an open anterior approach. The Brisbane and Gladstone ALIF systems may be used as stand-alone devices or in conjunction with supplemental fixation. When used as a stand-alone device the subject devices must be used with all three screws.

Source page: https://510kreport.com/device/K172019
Methodology: https://510kreport.com/methodology