Device Dossier

Osteomesh Series - Bone matrix implant, synthetic

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

Intended purpose

Osteomesh™ is a bone void filler. It is indicated for the repair of orbital floor fractures. The shape of the Osteomesh conforms to the defect, thus maximising direct contact with the viable bone host.

Functional description

Osteomesh is a sterile mesh scaffold bone void filler used to fill cranial defects. It is rectangular in shape. 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.

TGA Public Summary