Device Dossier

SIGNIFY Crunch - Graft, bone, synthetic

Device Dossier for SIGNIFY Crunch - Graft, bone, synthetic (Graft, bone, synthetic, Class III, sponsor Globus Medical). ARTG record, intended purpose,…

Intended purpose

SIGNIFY Bioactive is intended for use as a bone void filler and autograft extender in skeletally mature patients for voids or gaps that are not intrinsic to the stability of the bony structure. These osseous defects may be surgically created or created from traumatic injury to the bone. SIGNIFY is intended to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, pelvis, and spine). SIGNIFY resorbs and is replaced with bone during the healing process.

Functional description

SIGNIFY is resorbable,bone void filler for repair of bony defects. It is osteoconductive, osteostimulative,guides bone regeneration.In direct contact with host bone,new bone grows in apposition to the implant.As it resorbs,bone & connective tissues grow space previously occupied by SIGNIFY. Signify consist of Bioglass,PEG & glycerol,& available in putty, gel and crunch forms to accommodate surgical and anatomical needs.

TGA Public Summary