Device Dossier

Gender Solutions™ Natural-Knee® Flex System Rotating Platform Articular Surface Ultracongruent - Prosthesis, knee, internal, insert component

Device Dossier for Gender Solutions™ Natural-Knee® Flex System Rotating Platform Articular Surface Ultracongruent - Prosthesis, knee, internal, insert…

Intended purpose

Intended 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 valgus-varus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists.

Functional description

These are rotating platform articular surface component which is part of a semiconstrained total knee prosthesis intended for resurfacing of the knee joint. They are designed to be used with Rotating Platform tibial baseplates and femoral components and are manufactured from ultra-high molecular weight polyethylene (UHMWPE.

TGA Public Summary