Medacta Shoulder System PE Pegged Glenoid Highcross - Prosthesis, internal, joint, shoulder, glenoid component

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

MAH:

Medacta Australia Pty Ltd

class:

Class III

manufactured_by:

Medacta International SA Strada Regina 6874 Castel, San Pietro Switzerland

therapeutic_area:

36259 - Prosthesis, internal, joint, shoulder, glenoid component

therapeutic_indication:

The anatomic glenoid implant is a polyethylene (PE) component characterized by a spherical surface articulating on the humeral head, and a pattern of fixation pegs to be press-fit and cemented into the bone. The pegs have barbed structures that deform while the pegs are inserted into the bone, providing an immediate fixation even when the cement is still hardening. The Anatomic Medacta Shoulder System is intended for use as a hemi or total shoulder replacement. It is a single-use device for the reconstruction of the gleno-humeral joint in case of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis as well as complex fractures, post-traumatic malunion and revision of failed arthroplasty in patients with an intact or reparable rotator cuff shoulder joint. The humeral components are for cemented and cementless use.

authorization_status:

A

authorization_date:

2022-12-09