RBK Total Knee System, Tibia Insert Highflex - Prosthesis, knee, internal, insert component

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Dostopno od:

Corin Australia Pty Ltd

Razred:

Class III

Izdeluje:

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

Terapevtsko območje:

46585 - Prosthesis, knee, internal, insert component

Terapevtske indikacije:

The RBK Tibial Insert Highflex is an articulating component of the RBK Knee System that is manufactured from UHMWPE and has posterior cut-outs for increased range of motion in flexion. It is inserted into and rotates freely within the inner cone of the tibial prosthesis and articulates with the femoral prosthesis on its top surface. The Highflex insert is used in primary total knee replacement procedures only. It is not compatible with the RBK Revision Tibia baseplate. RBK Tibial Insert Highflex is a meniscal 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.

Status dovoljenje:

A

Datum dovoljenje:

2016-08-31