Device Dossier

Delta System Resorbable Screw - Fixation screw, bone, biodegradable

Device Dossier for Delta System Resorbable Screw - Fixation screw, bone, biodegradable (Fixation screw, bone, biodegradable, Class III, sponsor Stryker).…

Intended purpose

Intended for use in the fixation of bones of the craniofacial and midfacial skelton affected by trauma or for reconstruction.

Functional description

The Delta system consists of resorbable bone fixation plates, meshes and screws made from a terpolymer of polylactic and polyglycolic acids. The Delta system is used in the fixation of bones of the craniofacial and midfacial skelton affected by trauma or for reconstruction. The terpolymer degrade and resorbs in-vivo by hydrolysis into lactic and glycolic acids which are then metabolized by the body.

TGA Public Summary