Device Dossier

DURACON TOTAL STABLIZER (TS) CONSTRAINED TIBIAL INSERT - Prosthesis, knee, internal, insert component

Device Dossier for DURACON TOTAL STABLIZER (TS) CONSTRAINED TIBIAL INSERT - Prosthesis, knee, internal, insert component (Prosthesis, knee, internal,…

Intended purpose

A component of reconstructive knee system, connects with a tibial base plate and articulates with a femoral knee component. 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

Sterile Tibial Insert designed to connect with tibial tray for fixation and articulate with Femoral Component for a Total Knee Arthroplasty. Constrained intercondylar insert indicated in revisions where loss of one or both collateral ligaments or inability to balance collateral ligaments in flexion & extension. With a highly conforming tibiofemoral articulation. Tall tibial spine reinforced with preassembled Vitallium Alloy support post to resist varus/valgus forces Made of Polyethylene (UHMWPE)

TGA Public Summary