Device Dossier
chronOS Granules and Preforms - Bone matrix implant, artificial
Device Dossier for chronOS Granules and Preforms - Bone matrix implant, artificial (Bone matrix implant, synthetic, Class III, sponsor DePuy Synthes).…
- GMDN category: Bone matrix implant, synthetic
Intended purpose
Its function is as a temporary bone substitute, where it serves to fill and bridge aseptic bone defects in children, adolescents and adults. chronOS should be used as bone void fillers or augmentation material in areas requiring cancellous rather than cortical bone. chronOS implants are not indicated for use in load bearing and unstable indications unless used in conjunction with appropriate osteosynthesis fixation systems or if the cortical bone can bear the full load.
Functional description
Its function is as a temporary bone substitute, where it serves to fill and bridge aseptic bone defects in children, adolescents and adults. chronOS is supplied in cylinders, blocks and wedges which are pre-packed in one of four prefusion syringes according to the size of the device. chronOS granules are not supplied in a perfustion device as the granules can easily be perfused with autologous bone marrow or blood by mixing in a sterile bowl.