TRIATHLON TOTAL STABILISER (TS) PLUS X3 TIBIAL INSERT - Prosthesis, knee, internal, insert component

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Disponível em:

Stryker Australia Pty Ltd

Classe:

Class III

Fabricado por:

Howmedica Osteonics Corporation 325 Corporate Drive, Mahwah, New Jersey, 07430 United States Of America

Área terapêutica:

46585 - Prosthesis, knee, internal, insert component

Indicações terapêuticas:

A sterile implantable Tibial Insert, designed to be connected with a Tibial Tray/ Baseplate for fixation and to articulate with an artificial Femoral Component of the Triathlon Total Knee Arthroplasty (TKA). The post on the Tibial Insert fits within the articulating femoral component. Made of X3 polyethylene (highly cross-linked UHWMPE). The Total Stabiliser X3 Tibial Insert is a component of the Triathlon Total Knee System intended for Total Knee Arthroplasty (TKA). Indications include Painful, disabling joint disease of the knee resulting from noninflammatory degenerative joint disease; 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. The following indications apply in complex primary and/or revision Total Knee Arthroplasty - Ligamentous instability requiring implant bearing surface geometries with increased constraint; Absent or non-functioning posterior cruciate ligament; Severe anteroposterior instability of the knee joint; Severe instability of the knee secondary to compromised collateral ligament integrity or function.

Status de autorização:

A

Data de autorização:

2014-01-20