Device Dossier

Orthopaedic bone pin, non-bioabsorbable

Device Dossier for Orthopaedic bone pin, non-bioabsorbable (Orthopaedic bone pin, non-bioabsorbable, Class IIb, sponsor Akva Surgical). ARTG record,…

Intended purpose

Pinfix® is an intraosseous path also called half-pin, screw, pin-wire or k-wire, which acts as a connection between the fractured bone and the external fixator allowing to transfer the forces normally supported by the bone (vertical, lateral forces , rotational) to the external fixator to which they are connected with specially designed components and fixed by nuts and bolts. The aim is to mechanically stabilise the bone so that it can achieve healing or be modified in axial or angular elongation as a result of an orthopaedic treatment according to the callogenesis technique, provide mechanical support to the bone to stabilise fractures and perform deformity corrections.

TGA Public Summary