Device Dossier
Apex Knee System ECiMa PS-R Tibial Insert - Prosthesis, knee, internal, insert component
Device Dossier for Apex Knee System ECiMa PS-R Tibial Insert - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal, insert…
- GMDN category: Prosthesis, knee, internal, insert component
Intended purpose
The Apex ECiMa 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.
Functional description
The Apex ECiMa PS-R Tibial Insert is made of ECiMa polyethylene and intended for use with the same or plus size cemented PS Revision Femur. The device 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 bo