# K163625: NOOSA Anterior Lumbar Plate System;NAMBUCCA Anterior Lumbar Plate System; CAIRNS Anterior Lumbar Plate System

- Pathway: 510(k) (Traditional)
- Applicant: Signature Orthopaedics Pty, Ltd.
- Decided: Aug 11, 2017 after 232 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: 3 generations back to K922543 (1993). 7 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 10 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 4.
- K013665: Pyramid Anterior Plate Fixation System, Medtronic Sofamor Danek, Inc. (2002) Summary page 4.
- K022791: Synthes Anterior Tension Band (Atb) System, Synthes (Usa) (2002) Summary page 4.

## Most influential descendants
- K181190: Pinehurst Anterior Cervical Plate System (2019), 0 descendants of its own
- K172019: Brisbane ALIF Device, Gladstone ALIF Device (2017), 0 descendants of its own

## Indications for use
The Signature Orthopaedics NOOSA, NAMBUCCA, and CAIRNS Anterior Lumbar Plate Systems are 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. The devices are intended as temporary fixation devices until fusion is achieved. The subject systems are indicated in the treatment of lumbar or lumbosacral (L1-S1) fixation for the following indications: degenerative disc disease (DDD)(as define by back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudarthrosis, and failed previous fusion.

Source page: https://510kreport.com/device/K163625
Methodology: https://510kreport.com/methodology