Device Dossier

B-TCP Gel (GelOS) - Bone matrix implant, synthetic

Device Dossier for B-TCP Gel (GelOS) - Bone matrix implant, synthetic (Bone matrix implant, synthetic, Class III, sponsor Pureplay Orthopaedics). ARTG…

Intended purpose

GelOS is intended to be used as a synthetic bone void filler. It is only indicated for filling and/or augmenting bony voids or gaps that are not intrinsic to the stability of the bone structure i.e. subjected to either low load or compressive loading. If osseous defects are intrinsic to the stability and integrity of the skeleton, mechanical stability must be addressed prior to use.

Functional description

GelOS contains porous resorbable ?tcp granules that create an osteoconductive scaffold for new bone growth. The granules are constructed of ?-tricalcium phosphate suspended in an aqueous polymer carrier. It is implanted directly into bony voids or defects of the skeletal system. The water soluble carrier gel then dissolves leaving behind the calcium phosphate matrix which is resorbed and replaced with bone during the healing process. It is presented in an applicator.

TGA Public Summary