Device Dossier

Lumbar total disc replacement prosthesis

Device Dossier for Lumbar total disc replacement prosthesis (Lumbar total disc replacement prosthesis, Class IIb, sponsor Evolution Surgical). ARTG…

Intended purpose

Intended to replace the lumbar disc in patients with symptomatic Degeneratice Disc Disease (DDD) at lumbar levels L3-S1. A symptomatic degenerative disc is defined as back pain associated with structural changes confirmed by patient history and radiographic studies. Intended for use only if conservative care fails to reduce symptoms.

TGA Public Summary