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

Krajina: Austrália

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Dostupné z:

Corin Australia Pty Ltd

Trieda:

Class III

Výrobca:

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

Terapeutické oblasti:

46585 - Prosthesis, knee, internal, insert component

Terapeutické indikácie:

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.

Stav Autorizácia:

A

Dátum Autorizácia:

2016-08-31