Device Dossier
Modular Rotating Hinge Knee System Tibial Rotating Component - Rotating hinged total knee prosthesis
Device Dossier for Modular Rotating Hinge Knee System Tibial Rotating Component - Rotating hinged total knee prosthesis (Rotating hinged total knee…
- GMDN category: Rotating hinged total knee prosthesis
- Sponsor: Stryker
Intended purpose
A tibial bearing component of a Rotating Hinge Knee System designed to be used in total reconstructive replacement of the knee joint for the following condition(s): 1) There is destruction of the joint surfaces, with or without significant bone deformity. 2) The cruciate and/or collateral ligaments do not stabilize the knee joint. 3) The ligaments are inadequate and/or the musculature is weak, and/or, 4) Revision is required of a failed prostheses where there has been gross instability, with or without bone loss or inadequate soft tissue.
Functional description
Tibial bearing component connected to femoral component by set of bushings and axle.A bumper locks the assembly. Stem of the tibial bearing component fits into the PE tibial insert which is fixed to the tibia, providing motion in rotational plane and translation in axial plane. Made from UHMWPE. Additional tibial rotating component with 3mm posterior offset for L and XL femoral components offsets the femoral component posteriorly, relative to the tibial stem, to enable optimal patellar tracking.