Device Dossier

OSS knee RS elliptical segmental femoral porous coated - Coated knee femur prosthesis

Device Dossier for OSS knee RS elliptical segmental femoral porous coated - Coated knee femur prosthesis (Coated knee femur prosthesis, Class III,…

Intended purpose

Orthopaedic Salvage System cobalt chrome/titanium alloy porous coated reduced size elliptical segmental femoral implant 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 elliptical segmental distal femoral component utilised when no more than 7 or 8.5 cm distal femoral replacement is required. Accepts any non-collared OSS stems, and may be used with any OSS tibial options. RS femur utilizes and RS axle and RS poly femoral bushings. Reduced size rationale with 8mm reduction in M/L and 11MM reduction in A/P dimensions compared with standard OSS femoral implants. PPS coating enhances biological fixation to host bone.

TGA Public Summary