Device Dossier

OSS knee resurfacing femoral component porous coated - Coated knee femur prosthesis

Device Dossier for OSS knee resurfacing femoral component porous coated - Coated knee femur prosthesis (Coated knee femur prosthesis, Class III, sponsor…

Intended purpose

Orthopaedic Salvage System cobalt chrome/titanium alloy porous coated femoral resurfacing 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

Cobalt chrome/titanium alloy porous coated femoral resurfacing component intended for cemented use. Utilized for basic reconstruction of femur; replaces 3 or 5 cm of distal femur, accepts any non-collared OSS stems; may be used in conjunction with any OSS tibial options. M/L dimension 58.5MM; A/P dimension 57MM. PPS coating enhances biological fixation to host bone.

TGA Public Summary