Device Dossier

Orthopaedic bone screw, non-biodegradable, non-sterile

Device Dossier for Orthopaedic bone screw, non-biodegradable, non-sterile (Orthopaedic bone screw, non-biodegradable, non-sterile, Class IIb, sponsor…

Intended purpose

The Peg components have been designed as an optional uni-cortical peg for proximal locking of all sizes of the female Tibial/Humeral component as well as for distal locking of the Non-threaded (LON) Male components. The LON fixation is used when the distal epiphysis is too small or of too poor quality for a threaded fixation. The non-threaded fixation is pushed into the epiphysis and locked with a Guide Wire or Peg of the appropriate size which engages both cortices providing increased fixation in osteopenic bone and reducing the risk of migration.

TGA Public Summary