# K172020: Arlington PLIF/TLIF Cage

- Pathway: 510(k) (Traditional)
- Applicant: Signature Orthopaedics Pty, Ltd.
- Decided: Nov 29, 2017 after 147 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: 10 generations back to K841189 (1984). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101923: Concorde Curve System, Depuy Spine (2010) Summary page 4.
- K081888: Dynamik Intervertebral Body Fusion Device, Spineart (2009) Summary page 4.
- P960025: Brantigen I/F Cage (R) Used with VSP (R) Spine Plates and Pedicle Screws, Depuy Spine, Inc. (1999) Summary page 4.

## Indications for use
The Signature Orthopaedics Arlington PLIF/TLIF system is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). These DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Patients should have at least six months of nonoperative treatment prior to surgery. The device is to be used with autogenous bone graft. The Arlington PLIF/TLIF is used to facilitate fusion in the lumbar spine and are placed using either a PLIF or TLIF approach. Arlington PLIF/TLIF system is intended for use with supplemental internal fixation products.

Source page: https://510kreport.com/device/K172020
Methodology: https://510kreport.com/methodology