Device Dossier

Orthopaedic fixation plate, non-biodegradable

Device Dossier for Orthopaedic fixation plate, non-biodegradable (Orthopaedic fixation plate, non-biodegradable, Class IIb, sponsor Orthopediatrics AUS).…

Intended purpose

It is intended as a temporary implant, including non-bioabsorbable fixation plates, to aid in the correction of the angle of growth and the length of long bones (excluding craniofacial and spinal 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). The plates are designed to be fixed in place with screws.

TGA Public Summary