Device Dossier
DURACON ASYMMETRIC PATELLA - Polyethylene patella prosthesis
Device Dossier for DURACON ASYMMETRIC PATELLA - Polyethylene patella prosthesis (Polyethylene patella prosthesis, Class III, sponsor Stryker). ARTG…
- GMDN category: Polyethylene patella prosthesis
- Sponsor: Stryker
Intended purpose
A component of a total knee joint intended to replace the natural patella. Indications for use of total knee replacement prostheses include: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis or avascular necrosis; 2) rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; 5) post-traumatic loss of joint anatomy, particularly when there is patello-femoral erosion, dysfunction or prior patellectomy; and, 6) irreparable fracture of the knee.
Functional description
A sterile implantable component of the Duracon Total Knee System, designed as an artificial substitute for the natural patella (kneecap), designed to articulate with the distal femoral component of a Total Knee Arthroplasty (TKA). Made of polyethylene (UHMWPE).