APEX Knee System, PS-R Tibial Insert - Prosthesis, knee, internal, insert component

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Available from:

Corin Australia Pty Ltd

Class:

Class III

Manufactured by:

Omni Life Science Inc 480 Paramount Drive, Raynham, Massachusetts, 02767 United States Of America

Therapeutic area:

46585 - Prosthesis, knee, internal, insert component

Therapeutic indications:

The APEX PS-R Insert is made of UHMWPE and intended for use with the same size or a plus size cemented PS Revision Femur. The PS-R insert allows high levels of joint conformity, minimizing stress on the insert and reducing polyethylene wear. The tibial articular components are available in various thicknesses to aid in obtaining appropriate soft tissue balance and joint line height. The inserts attach to the titanium tibial tray using interlocking rails and a central locking bolt. The APEX PS-R Insert is a sterile component of ?The APEX Knee System?, which is intended for use in revision total knee replacement procedures only. The indications for use include: ? Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; ? Rheumatoid arthritis; ? Correction of functional deformity; and ? Revisions procedures where other treatments or devices have failed. The APEX Revision Knee is designed to provide surgeons intra-operative versatility, allowing them to effectively provide patients with restored range of motion and pain relief.

Authorization status:

A

Authorization date:

2018-11-02