Device Dossier

Orthopaedic bone screw, non-bioabsorbable, sterile

Device Dossier for Orthopaedic bone screw, non-bioabsorbable, sterile (Orthopaedic bone screw, non-bioabsorbable, sterile, Class IIa, sponsor Becton…

Intended purpose

A small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone during surgical procedures only. It is made of a material that cannot be chemically degraded or absorbed via natural body processes (generally implant grade metal such as surgical steel, titanium alloy, or carbon fibre). This device is surgically invasive for short term use (less than 30 days) only.

TGA Public Summary