RBK Knee System, Revision Stem Cemented - Knee stem

Riik: Austraalia

keel: inglise

Allikas: Department of Health (Therapeutic Goods Administration)

Osta kohe

Avaliku hindamisaruande Avaliku hindamisaruande (PAR)
04-11-2017

Saadav alates:

Corin Australia Pty Ltd

Klass:

Class III

Valmistatud:

Global Manufacturing Technology Pty Ltd 17 Bridge Street, Pymble, NSW, 2073 Australia

Terapeutiline ala:

48066 - Knee stem

Näidustused:

The RBK Revision Stem is the Tibial Stem used in the RBK Knee System. The RBK Revision Stem is made of titanium-aluminium-vanadium alloy and is affixed to the underside of the RBK Revision Tibial baseplate by both a Morse taper and a reinforcement screw prior to inserting into the prepared tibial canal of the patient during knee replacement surgery. This device is intended for use with bone cement. RBK Revision Stem connects to the RBK Revision Tibia component of the RBK System and is indicated for use in primary total knee arthroplasty for reduction or relief of pain and/or improved knee function in skeletally mature patients with the following conditions: 1. Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis. 2. Inflammatory degenerative joint disease including rheumatoid arthritis. 3. Correction of functional deformity. 4. Revision of primary uni-compartmental knee replacements.

Volitamisolek:

A

Loa andmise kuupäev:

2016-08-10

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