Device Dossier

INION CompressOn™ - Fixation screw, bone, biodegradable

Device Dossier for INION CompressOn™ - Fixation screw, bone, biodegradable (Fixation screw, bone, biodegradable, Class III, sponsor NATON MEDICAL AUS).…

Intended purpose

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

Functional description

The INION CompressOn™ products are cannulated headless compression screws made of degradable co-polymers composed of L-lactic acid and D-lactic acid. These polymers have a long history of safe medical use and they degrade in vivo by hydrolysis into alpha-hydroxy acids that are metabolised by the body.

TGA Public Summary