Device Dossier

Orthopaedic bone bolt

Device Dossier for Orthopaedic bone bolt (Orthopaedic bone bolt, Class IIb, sponsor Orthopediatrics AUS). ARTG record, intended purpose, GMDN category —…

Intended purpose

It is intended as a temporary implant, including an orthopaedic bone bolt inserted through a long bone (typically the proximal tibia or distal femur), fastened with a nut/washer, to aid in the correction of the angle of growth and the length of long bones by modulating growth of the physis in pediatric (child and adolescent) patients, supporting correction of angular or rotational deformities and limb length discrepancy (LLD).

TGA Public Summary