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 Medacta).…

Intended purpose

Device intended to be used as guides specifically designed for the anatomy of a single patient. The humeral guide is used to define the level and orientation of the humeral head resection cut. The glenoidal guide is used to position and orient the K-wire that will subsequently guide the glenoidal reaming. Both anatomical and reverse total joint configurations are acceptable.

TGA Public Summary