Affinis Stem Cemented - Uncoated shoulder humeral stem prosthesis

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

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Javno poročilo o oceni Javno poročilo o oceni (PAR)
09-11-2017

Dostopno od:

Mathys Orthopaedics Pty Ltd

Razred:

Class III

Izdeluje:

Mathys AG Bettlach Mathys Ltd Bettlach Mathys SA Bettlach Robert Mathys Strasse 5, Bettlach, 2544 Switzerland

Terapevtsko območje:

34197 - Uncoated shoulder humeral stem prosthesis

Terapevtske indikacije:

The Affinis cemented stem has grooves to ensure safe anchoring in the cement coating, and forms part of the Affinis Total Shoulder Prosthesis which offers precise adjustability to the existing anatomy to restore the center of rotation and exact reconstruction of the proximal humerus. The Affinis cemented stem forms part of the Affinis Total Shoulder System that is designed for treating shoulder conditions such as Primary Osteoarthritis, Secondary Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Osteoarthritis, Cuff Tear Arthropathy (Hamada grade III or IV) in younger patients, Metabolic joint destruction (e.g. chondrocalcinosis, haemo- siderosis, urate arthropathy)), fracture sequelae (malformation healing of humeral head fractures, non union healing/ pseudarthrosis, head necrosis, locked dislocations) and avascular head necrosis

Status dovoljenje:

A

Datum dovoljenje:

2014-01-20

Opozorila o iskanju, povezana s tem izdelkom