Device Dossier

INION FreedomPin™ - Fixation pin, biodegradable

Device Dossier for INION FreedomPin™ - Fixation pin, biodegradable (Fixation pin, biodegradable, Class III, sponsor NATON MEDICAL AUS). ARTG record,…

Intended purpose

The INION FreedomPin™ products are indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts in the presence of appropriate additional immobilization (e.g. rigid fixation implants, cast, brace).

Functional description

The INION FreedomPin™ products are intended to maintain accurate alignment of fragments of fractured bone in the presence of appropriate immobilization. The INION FreedomPin™ products are made of degradable co-polymers composed of L-lactic acid and D-lactic acid. These polymers have a long history of medical use and they degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolised by the body.

TGA Public Summary