Device Dossier
Fixation device, external, system
Device Dossier for Fixation device, external, system (Fixation device, external, system, Class IIb, sponsor Zimmer Biomet). ARTG record, intended…
- GMDN category: Fixation device, external, system
Intended purpose
Indicated 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. It consists of a case(s) and trays and includes a number of implants, together with the appropriate instrumentation. Intended for stabilisation of open or closed fractures, typically in the context of polytrauma or where open or alternative closed treatment is undesirable or otherwise contraindicated; arthrodesis and osteotomies with associated soft tissue problems; stabilisation of limbs after removal of total joint arthroplasty for infection or other failure; stabilisation of non-unions and intraoperative temporary stabilization tool to assist with indirect reduction.