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).…
- GMDN category: Fixation screw, bone, biodegradable
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.