Device Dossier

OSS Arcom UHMWPE Bumper lock pin - Rotating hinged total knee prosthesis

Device Dossier for OSS Arcom UHMWPE Bumper lock pin - Rotating hinged total knee prosthesis (Rotating hinged total knee prosthesis, Class III, sponsor…

Intended purpose

Orthopaedic Salvage System poly bumper lock pin for patients presenting bone loss and deformity associated with bone tumors resection, trauma, and difficult revision arthroplasty. Indications include 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 successful osteotomy, arthrodesis, or previous joint replacement; Ligament deficiencies; Tumor 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

The UHMWPE OSS Bumper Lock Pin engages the Reinforced Yoke and Axle to restrict extension to 0 degrees.

TGA Public Summary