Device Dossier

OSS Interlok bowed intramedullary stem 11MM diameter with screw with porous coated collar - Knee stem

Device Dossier for OSS Interlok bowed intramedullary stem 11MM diameter with screw with porous coated collar - Knee stem (Knee stem, Class III, sponsor…

Intended purpose

Orthopaedic Salvage System titanium alloy Interlok collared bowed intramedullary stem 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

Ti alloy Interlok intramedullary stem with 1 cm porous coated collar; adds 1 cm of replacement length to any segmental replacement where a bowed stem meets the surgical protocol: proximal femur, distal femur. Intended for cemented use; packaged with screw.

TGA Public Summary