Device Dossier

Osteoplug-C Series - Bone matrix implant, synthetic

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

Intended purpose

Osteoplug -C is a bone void filler intended for use in the repair of neurosurgical burr holes, craniotomy cuts and other cranial defects and allows for the insertion of catheter after cerebral shunt operations.

Functional description

Osteoplug-C is a sterile mesh scaffold bone void filler used to fill cranial defects. It 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. The Osteoplug-C has a 4mm inner through-hole allowing insertion of a catheter after a cerebral shunt operation.

TGA Public Summary