Device Dossier

Fixation nail, intramedullary, arthrodesis

Device Dossier for Fixation nail, intramedullary, arthrodesis (Fixation nail, intramedullary, arthrodesis, Class IIb, sponsor Zimmer Biomet). ARTG…

Intended purpose

These devices are intended for use in the replacement of segmental defects of long bone, including midshaft replacement, and arthrodesis of the knee. Indications include: 1.) Treatment of patients who are not candidates for total knee arthroplasty, 2.) Irretrievably failed total knee arthroplasty. 3.) Limb salvage in oncology surgery. 4.) Trauma 5.) Any other condition where there is little soft tissue or bony tissue available for support and arthrodesis is the treatment of choice.

TGA Public Summary