Device Dossier

Gender Solutions™ Natural-Knee® Flex System Prolong™ Highly Crosslinked Polyethylene Articular Surface Congruent - Prosthesis, knee, internal, insert component

Device Dossier for Gender Solutions™ Natural-Knee® Flex System Prolong™ Highly Crosslinked Polyethylene Articular Surface Congruent - Prosthesis, knee,…

Intended purpose

The Congruent Articular Surface component of the Gender Solutions Natural-Knee Flex System is indicated for use in skeletally mature individuals with intact medial and lateral collateral ligaments with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable varus?valgus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists.

Functional description

Anatomically designed articular surface component of the The Gender Solutions Natural-Knee Flex semiconstrained total knee prosthesis system for resurfacing of the knee joint. It is made from ultra-high molecular weight polyethylene (UHMWPE), and is available in multiple thicknesses to facilitate soft tissue tensioning and joint line restoration.

TGA Public Summary