Device Dossier

Natural-Knee® II System Durasul, UltraCongruent Tibial Insert - Prosthesis, knee, internal, insert component

Device Dossier for Natural-Knee® II System Durasul, UltraCongruent Tibial Insert - Prosthesis, knee, internal, insert component (Prosthesis, knee,…

Intended purpose

Ultracongruent tibial insert component of the NK II semiconstrained total knee prosthesis system intended for patient conditions of noninflammatory degenerative joint disease (NIDJD), avascular necrosis, osteoarthritis, inflammatory degenerative joint disease (IJD), rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain, deformity, or dysfunction persists; and revision of previously failed knee arthroplasty.

Functional description

Anatomically designed ultracongruent tibial insert component of the NK II semiconstrained total knee prosthesis designed for use where the posterior cruciate ligament is absent, deficient, or has been removed at the time of surgery. Manufactured from ultra-high molecular weight polyethylene (UHMWPE). Intended for cemented use only.

TGA Public Summary