Device Dossier

1.5mm Bone Fixation Kit - Surgical procedure kit, arthroscopic, single-use, non-medicated

Device Dossier for 1.5mm Bone Fixation Kit - Surgical procedure kit, arthroscopic, single-use, non-medicated (Surgical procedure kit, arthroscopic,…

Intended purpose

The SmartNail® Bone Fixation Kit is presented as a sterile, single-use kit intended for use in the fixation of fragments of fractured non-load bearing bones, for example in the fixation of apical fragments, osteochondral fragments and cancellous/non-load bearing fragments in the presence of appropriate brace and/or immobilisation.

Functional description

A kit containing one or two bioabsorbable polylactide copolymer nails for fracture fixation, packaged with an insertion piston, insertion sheaths and separately packaged K-Wires. The K-Wire is used to create a tunnel of correct depth for the nail before the insertion sheath (containing the Nail) is placed over the tunnel. The insertion piston then advances the nail implant until fully seated.

TGA Public Summary