Device Dossier
OSTEOSET XR Pellets Bone Graft Substitute - Bone matrix implant, artificial
Device Dossier for OSTEOSET XR Pellets Bone Graft Substitute - Bone matrix implant, artificial (Bone matrix implant, synthetic, Class III, sponsor…
- GMDN category: Bone matrix implant, synthetic
- Sponsor: Stryker
Intended purpose
For use as a bone void filler to be gently packed into open bone voids/gaps that are not intrinsic to the stability of bony structures of the skeletal system (i.e., the extremities, spine, and pelvis). These open bone voids may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The pellets provide a bone void filler that resorbs and is replaced with bone during the healing process.
Functional description
Preformed calcium sulfate / calcium phosphate pellets provided in glass vials that are gently packed into open bone voids/gaps. The pellets provide a bone void filler that resorbs and is replaced with bone during the healing process.