Device Dossier

Osteoplug Series - Bone matrix implant, synthetic

Device Dossier for Osteoplug Series - Bone matrix implant, synthetic (Bone matrix implant, synthetic, Class III, sponsor Osteopore). ARTG record,…

Intended purpose

Osteoplug is indicated for the repair of neurosurgical burr holes and fresh craniotomy cuts.

Functional description

Osteoplug is a sterile mesh scaffold bone void filler used to fill cranial defects. It is a circular plug shape and conforms to the shape of the defect thus maximising direct contact with the viable bone host. It is made of polycaprolactone which degrades and resorbs fully in vivo by hydrolysis, then is metabolised by the body. This will occur over a period of 18-24 months.

TGA Public Summary