SMR Stemless Core Ti6Al4V - Uncoated shoulder humeral stem prosthesis

Country: Australia

Bahasa: Inggeris

Sumber: Department of Health (Therapeutic Goods Administration)

Beli sekarang

Download Laporan Penilaian Awam (PAR)
07-11-2017

Boleh didapati daripada:

Lima Orthopaedics Australia Pty Ltd

Kelas:

Class III

Dikeluarkan oleh:

Limacorporate Spa Via Nazionale 52, San Daniele del Friuli, Frazione Villanova Udine, 33038 Italy

Kawasan terapeutik:

34197 - Uncoated shoulder humeral stem prosthesis

Tanda-tanda terapeutik:

The SMR Stemless Core presents a taper connection to allow the coupling with SMR Stemless adaptor tapers or SMR Stemless Reverse Liners. The SMR Stemless System is intended for partial or total, primary or revision shoulder joint replacement. Revision surgery is intended only where the Stemless Core is stable, well positioned and osseointegrated and it is intended only as revision of a failed SMR Stemless primary implant with an anatomic implant or a conversion from anatomic to reverse or CTA or from reverse to CTA or in case of a failed SMR Resurfacing implant. Other revisions of the humeral prosthesis part should be treated with traditional shoulder prostheses. The SMR Stemless Anatomic System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to: ? non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis; ? inflammatory degenerative joint disease such as rheumatoid arthritis; ? revision of a failed SMR Stemless primary implant with conversion from anatomic to reverse; ? revision of a failed SMR Resurfacing implant; ? cuff tear arthropathy (CTA Heads only). The SMR Stemless Reverse System is indicated for primary or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically and structurally suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

Status kebenaran:

A

Tarikh kebenaran:

2015-04-02

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