Device Dossier

HydroSet HA bone substitute - Bone matrix implant, artificial

Device Dossier for HydroSet HA bone substitute - Bone matrix implant, artificial (Bone matrix implant, synthetic, Class III, sponsor Stryker). ARTG…

Intended purpose

HydroSet is a self-setting calcium phosphate cement indicated to fill bony voids or gaps of the skeletal system (i.e. extremities and craniofacial). These defects may be surgically created or osseous defects created from traumatic injury to the bone. HydroSet is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. HydroSet cured in situ provides an open void / gap filler that can augment provisional hardware (e.g. K-Wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary support media and is not intended to provide structural support during the healing process.

Functional description

Injectable hydroxyapatite (HA) bone substitute

TGA Public Summary