Device Dossier

Orthopaedic external fixation system, single-use, non-sterile

Device Dossier for Orthopaedic external fixation system, single-use, non-sterile (External orthopaedic fixation system, single-use, Class IIb, sponsor…

Intended purpose

For use in construction of an external fixation frame for treatment of long bone (foot, femur, tibia and humerus) and pelvic fractures that require external fixation. Intended for stabilization of limbs after removal of total joint arthroplasty for infection or other failure, open or closed fractures, non-unions and arthrodesis and osteotomies with associated soft tissue problems.

TGA Public Summary