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.