Device Dossier

Custom-made orthopaedic surgical guide, non-sterile

Device Dossier for Custom-made orthopaedic surgical guide, non-sterile (Custom-made orthopaedic surgical guide, non-sterile, Class IIa, sponsor…

Intended purpose

The i.M.A.G.E. patient-matched pin positioners are for the AMPLITUDE total knee prosthesis. They consist of tibial and femoral pin positioning guides that allow the placement of cutting guides. The i.M.A.G.E. system is intended to make available to the user an instrumentation that is specifically adapted to the patient's anatomy in order to precisely position the pins and cutting guides and perform the bone cuts in compliance with the preoperative plan.

TGA Public Summary