Device Dossier

GMK Hinge Tibial Tray Fixed TiNbN Coated Cemented - Uncoated knee tibia prosthesis, metallic

Device Dossier for GMK Hinge Tibial Tray Fixed TiNbN Coated Cemented - Uncoated knee tibia prosthesis, metallic (Uncoated knee tibia prosthesis,…

Intended purpose

The GMK HINGE knee prosthesis is designed for cemented use in total knee arthroplasty when the preoperative diagnosis of the joint in skeletally mature patients determines that the bone and stability situation require the implantation of a constrained prosthesis. The GMK HINGE knee system is indicated in the following cases: • Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis associated with bone loss and/or severe joint instability • Considerable loss of function of the knee joint • High-grade joint destruction requiring additional stabilization with stems and reconstruction of bone defects with metal augmentation • Failure of a primary prosthesis (e.g. infection, loosening) • Former revision arthroplasty • Post traumatic loss of joint configuration • Avascular necrosis of the femoral condyle.

Functional description

The GMK HINGE KNEE SYSTEM is intended to preserve the joint functionality without dramatically altering its anatomy and kinematics, even in cases of severe ligament instability or massive bone defects. The GMK Hinge Tibial Tray Fixed TiNbN Coated Cemented is manufactured from cobalt chrome with a TiNbN coating. The distal keel with two wings to increase the rotational stability and it has 4 distal threaded holes to fix tibial augmentation.

TGA Public Summary