Device Dossier
DURACON UNIVERSAL TIBIAL BASEPLATE, NON BEADED - Uncoated knee tibia prosthesis, metallic
Device Dossier for DURACON UNIVERSAL TIBIAL BASEPLATE, NON BEADED - Uncoated knee tibia prosthesis, metallic (Uncoated knee tibia prosthesis, metallic,…
- GMDN category: Uncoated knee tibia prosthesis, metallic
- Sponsor: Stryker
Intended purpose
A component of a reconstructive knee system that connects with a tibial insert that articulates with a femoral knee component. Indications for use of total knee replacement prostheses include: 1) non-inflammatory 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 Tibial Tray/ Baseplate, designed to connect with a Tibial Insert that articulates with an artificial Femoral Component of the Duracon Total Knee Arthroplasty (TKA) System. Keel Designed with wide posteriorly angled fins, with the option for an extension stem to be attached, when required. Intended for use with cement. Made of Cast Vitallium Alloy.