Device Dossier

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Device Dossier for Orthopaedic fixation plate, non-bioabsorbable, non-sterile (Orthopaedic fixation plate, non-bioabsorbable, non-sterile, Class IIb,…

Intended purpose

A non-sterile implantable sheet of firm material intended to be attached to fractured bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals. The material is not chemically degraded or absorbed by natural body processes. The device is typically used to treat traumatic or pathological orthopaedic fractures. It may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion). This device is intended to be sterilized prior to use.

TGA Public Summary