Device Dossier
Osteoflo-G - Bone matrix implant, synthetic
Device Dossier for Osteoflo-G - Bone matrix implant, synthetic (Bone matrix implant, synthetic, Class III, sponsor Signature Orthopaedics). ARTG record,…
- GMDN category: Bone matrix implant, synthetic
Intended purpose
The device is intended for use as a bone void filler for bony voids or gaps of the skeletal system (e.g. extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. The device can be used with autograft as a bone graft extender. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.
Functional description
The device is a microporous and macroporous biphasic calcium phosphate ceramic consisting of 60% Hydroxyapatite (HA) and 40% beta-Tricalcium Phosphate (ß-TCP). When packed into a bony site, the device gradually resorbs and is replaced with bone during the healing process.