Device Dossier
BioSphere Bone Graft Putty - Bone matrix implant, synthetic
Device Dossier for BioSphere Bone Graft Putty - Bone matrix implant, synthetic (Bone matrix implant, synthetic, Class III, sponsor Evolution Surgical).…
- GMDN category: Bone matrix implant, synthetic
Intended purpose
BioSphere Putty is indicated for use in bony voids or gaps of the skeletal system (spine, extremities, and pelvis) in accordance with its intended use. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. BioSphere Putty may be combined with autograft or allograft. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Functional description
BioSphere Putty is a synthetic bioactive glass sphere-based bone graft material in a resorbable natural phospholipid carrier. It supports bone growth on its surface, forms a hydroxyapatite layer when placed in bone & provides an environment in which new bone is formed. The carrier holds the glass spheres together in a moldable form & is absorbed locally 5-7 days post-implantation. The putty is non-hardening, resists irrigation & provides effective intra-operative handling.