Device Dossier
HMRS KMFTR, Revision Bushing - Uncoated knee tibia prosthesis, metallic
Device Dossier for HMRS KMFTR, Revision Bushing - Uncoated knee tibia prosthesis, metallic (Uncoated knee tibia prosthesis, metallic, Class III, sponsor…
- GMDN category: Uncoated knee tibia prosthesis, metallic
- Sponsor: Stryker
Intended purpose
A bushing component of the Modular Replacement System, intended for use in patients requiring extensive reconstruction of the knee joint, necessitated by extensive bone loss due to trauma, failed previous prosthesis and/or tumor resection.
Functional description
A bushing component of a Rotating Hinge Knee System, inserted into the housing of the selected tibial bearing component and connected to the femoral component with an Axle. The polyethylene Bushings are inserted from the inner side of the femoral condyles. Manufactured from Duration Ultra-High-Molecular-Weight Polyethylene (UHMWPE).