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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 ALF cage. The Australis Spinal System is indended for use with supplemental fixation, such as the Prism Surgical Aurora® Anterior Lumbar Plate System.

The Prism Surgical Designs Australis® Anterior Lumbar Interbody Fusion (ALIF) Cage System (also referred to as Australis® Spine System and Australis® Spinal System) implants are intended to replace lumbar interbody discs and to fuse adjacent vertebral bodies following anterior lumbar discectomy stabilization and/or alignment of the lumbar spine. The Australis® ALIF cage is designed to be implanted via an anterior approach to the spine. The devices consist of wedge-shaped geometry to restore lordosis of the fused vertebral bodies and serrated teeth with three titanium pins on the inferior and superior surfaces to resist expulsion The center of the device is hollow to accept autograft and/or allograft bone graft material comprised of cancellous and/or corticocancellous bone graft to promote arthrodesis. The Australis® ALIF Cage System is to be used in conjunction with supplemental fixation. The Australis® ALIF is offered in a variety of footprints and heights to accommodate the anatomical needs of patients. The Australis® ALIF is manufactured from PEEK per ASTM F2026 with titanium pins per ASTM F136 and ISO 5832-3 and tantalum marker beads per ASTM F560 and ISO 13782.