Device Dossier
PERSONA™, The Personalized Knee System, Inset All Poly Patella, Cemented - Polyethylene patella prosthesis
Device Dossier for PERSONA™, The Personalized Knee System, Inset All Poly Patella, Cemented - Polyethylene patella prosthesis (Polyethylene patella…
- GMDN category: Polyethylene patella prosthesis
Intended purpose
The patellar component of Persona™, The Personalized Knee System, which is a semiconstrained total knee prosthesis. This device is indicated for patients with severe knee pain and disability due to: – Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. – Collagen disorders, and/or avascular necrosis of the femoral condyle. – Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. – Moderate valgus, varus, or flexion deformities. – The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
Functional description
The patellar component of Persona™, The Personalized Knee System, which is a semiconstrained total knee prosthesis. It is made from ultra-high molecular weight polyethylene (UHMWPE)and attached to the bone with three fixation pegs and bone cement.