Device Dossier

SERIES 7000 TIBIA TRAY - Uncoated knee tibia prosthesis, metallic

Device Dossier for SERIES 7000 TIBIA TRAY - Uncoated knee tibia prosthesis, metallic (Uncoated knee tibia prosthesis, metallic, Class III, sponsor…

Intended purpose

A non articulating component of a reconstructive knee system that connects with a tibial insert that articulates with a femoral knee component. Indications • Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis. • Post-traumatic loss of knee joint configuration and function. • Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function and stability. • Revision of previous unsuccessful knee replacement or other procedure.

Functional description

A sterile implantable Tibial Tray/ Baseplate, designed to house a Cruciate Retaining or Posteriorly Stabilised Tibial Insert that articulates with an artificial Femoral Component of the Series 7000 Total Knee Arthroplasty (TKA) System. A waffle design, no screw holes, keel and with the option for an extension stem to be attached, when required. Intended for use with cement. Made of Cobalt Chrome.

TGA Public Summary