Device Dossier

AttraX Putty Bone Void Filler - Bone matrix implant, artificial

Device Dossier for AttraX Putty Bone Void Filler - Bone matrix implant, artificial (Bone matrix implant, synthetic, Class III, sponsor Nuvasive…

Intended purpose

AttraX Putty Bone Void Filler is intended for use as bone void filler for voids and gaps that are not intrinsic to the stability of the bony structure. AttraX is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. AttraX is intended to be packed into bony voids or gaps of the skeletal system (i.e., extremities, spine, and pelvis) and may be combined with autogenous bone, blood, PRP, and/or bone marrow. AttraX should not be used to treat large defects that in the surgeon’s opinion would fail to heal spontaneously. In load bearing situations, AttraX is to be used in conjunction with internal or external fixation devices. Application in general bone surgery - replacing or supplementing autogenous/allogenous spongiosa, e.g., for: • Filling and bridging of skeletal bone defects including spine. • Plastic reconstruction of damaged or resectioned bone areas. • Filling of intervertebral implants.

Functional description

AttraX Putty Bone Void Filler consists of beta TCP and hydroxyapatite in a putty form. It induces and guides the three-dimensional regeneration of bone in the defect site into which it is implanted. When placed next to viable host bone, new bone will be deposited on the surface of AttraX. It then resorbs and is replaced by bone during the natural process of bone remodelling.

TGA Public Summary