Device Dossier

INION OTPS FreedomPlate™ - Fixation plate, fracture-healing, biodegradable

Device Dossier for INION OTPS FreedomPlate™ - Fixation plate, fracture-healing, biodegradable (Fixation plate, fracture-healing, biodegradable, Class…

Intended purpose

In the presence of appropriate additional immobilization or fixation, indicated for maintenance of alignment and fixation of bone fractures, osteotomies, arthrodeses or bone grafts, and maintenance of relative position of weak bony tissue (e.g., bone grafts, bone graft substitutes, or bone fragments from comminuted fractures), in trauma and reconstructive procedures.

Functional description

The INION OTPS FREEDOMPLATE™ biodegradable implants are made of degradable co-polymers composed of L-lactic acid, D-lactic acid and trimethylene carbonate. 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