Device Dossier

NexGen Complete Knee Solution Augmentation Patella - Metal-backed patella prosthesis

Device Dossier for NexGen Complete Knee Solution Augmentation Patella - Metal-backed patella prosthesis (Metal-backed patella prosthesis, Class III,…

Intended purpose

The NexGen Complete Knee Solution Augmentation Patella is intended for knee arthroplasty for the following indications: 1. Non-inflammatory degenerative joint disease including osteoarthritis or traumatic arthritis 2. Rheumatoid arthritis 3. Correction of functional deformity 4. Revision procedures where other treatments or devices have failed 5. Treatment of fractures that are unmanageable using other techniques 6. Complications from a failed prosthesis 7. For cementless use only 8. Supplemental fixation, when required, must be achieved by means of suture attachment. This product is not intended to be used in primary knee arthroplasty.

Functional description

The NexGen Complete Knee Solution Augmentation Patella consists of a polyethylene patella for articulation with the NexGen femoral component and an augmentation patella base made from porous tantalum with a press-fit titanium alloy suture ring for supplemental soft tissue fixation. Both these components have an oval geometry and are intended for cementless use.

TGA Public Summary