Medacta Shoulder System Humeral Head CoCr - Humeral head prosthesis

国家: 澳大利亚

语言: 英文

来源: Department of Health (Therapeutic Goods Administration)

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下载 公众评估报告 (PAR)
19-07-2023

可用日期:

Medacta Australia Pty Ltd

类:

Class III

厂商:

Medacta International SA Strada Regina 6874 Castel, San Pietro Switzerland

治疗领域:

48088 - Humeral head prosthesis

疗效迹象:

The Humeral Head is coupled to the Double Eccenter by means of an eccentric Morse taper connection. The Double Eccenter provides a 2.5mm offset with respect to the stem, while the Humeral Head provides a 2.5mm offset with respect to the Double Eccenter. By adjusting the angular positions of the Double Eccenter and the Humeral Head, it is possible to obtain infinite offset values ranging from 0mm to 5mm in infinite possible directions. 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.

授权状态:

A

授权日期:

2022-12-09

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