Device Dossier

Custom-made orthopaedic surgical guide, non-sterile

Device Dossier for Custom-made orthopaedic surgical guide, non-sterile (Custom-made orthopaedic surgical guide, non-sterile, Class IIa, sponsor MicroPort…

Intended purpose

Patient-specific surgical instrumentation to assist in the positioning of total knee replacement components intra-operatively and in guiding the marking of bone before cutting. The PROPHECY® Pre-Operative Navigation Alignment Guides are intended for use with MicroPort’s EVOLUTION® Total Knee Systems and their cleared indications for use, provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans. The PROPHECY® Pre-Operative Navigation Alignment Guides are intended for single use only.

TGA Public Summary