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…
- GMDN category: Uncoated knee tibia prosthesis, metallic
- Sponsor: Stryker
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.