Device Dossier
Inion FreedomScrew - Fixation screw, bone, biodegradable
Device Dossier for Inion FreedomScrew - Fixation screw, bone, biodegradable (Fixation screw, bone, biodegradable, Class III, sponsor NATON MEDICAL AUS).…
- GMDN category: Fixation screw, bone, biodegradable
Intended purpose
To hold plates to bone, fasten soft tissue to bone or provide inter fragmentary stabilisation for bone.
Functional description
The Inion FreedomScrew products are fixation screws made of degradable co-polymers composed of L-lactic acid and Dlactic 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. Based on in vitro testing, the screws retain their initial strength up to 12 weeks after implantation and gradually lose their strength thereafter. Bioresorption takes place within two to four years.