Device Dossier

OSS RS Modular Proximal Tibia - Coated knee tibia prosthesis

Device Dossier for OSS RS Modular Proximal Tibia - Coated knee tibia prosthesis (Coated knee tibia prosthesis, Class III, sponsor Zimmer Biomet). ARTG…

Intended purpose

The OSS RS Modular Proximal Tibia is a component of the OSS Orthopedic Salvage System intended for limb salvage procedures, resurfacing and revision applications. OSS System 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

The RS 9 cm Proximal Tibial Component features a reduced size rationale of 34 mm AP and 51 mm M/L. This implant may be coupled directly with any collared stem or diaphyseal segment/stem to reconstruct the proximal tibia.

TGA Public Summary