Device Dossier

Dispenser, cement, orthopaedic

Device Dossier for Dispenser, cement, orthopaedic (Dispenser, cement, orthopaedic, Class IIa, sponsor RTI Surgical). ARTG record, intended purpose, GMDN…

Intended purpose

The HPS™ single use instruments are intended to aid in the permanent implantation of the HPS™ Hybrid Performance System implants (HPS™ Polyaxial pedicle screw, fenestrated) and Streamline TL/MIS Fenestrated Spinal Fixation System (Streamline TL/MIS Fenestrated screw). The HPS™ / Streamline TL/MIS Cement injection set is used to inject the cement into the Polyaxial pedicle screw, fenestrated. The bone cement is not supplied with the device. The HPS™ / Streamline TL/MIS Cement injection set is a manually-operated syringe-like device intended for use in placing orthopaedic bone cement into Polyaxial pedicle screws. This is a single-use device.

TGA Public Summary