Device Dossier

OSS knee modular proximal tibia porous coated 9CM - Coated knee tibia prosthesis

Device Dossier for OSS knee modular proximal tibia porous coated 9CM - Coated knee tibia prosthesis (Coated knee tibia prosthesis, Class III, sponsor…

Intended purpose

Orthopaedic Salvage System titanium alloy porous coated modular proximal tibial component for patients presenting with bone loss and deformity associated with bone tumors resection, trauma, and difficult revision arthroplasty. Indications: Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis; Correction of varus, valgus, or posttraumatic deformity; Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement; Ligament deficiencies; Tumour resections; Treatment of non-unions, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques; Revision of previously failed total joint arthroplasty; Trauma

Functional description

Titanium alloy porous coated modular proximal tibia component with 9cm resection for use with any diaphyseal segments or collared stems to replace proximal tibia. Anterior PPS coating as well as suture holes in the M/L and A/P planes for reattachment of extensor mechanism.

TGA Public Summary