Device Dossier

Orthopaedic fixation plate, non-biodegradable

Device Dossier for Orthopaedic fixation plate, non-biodegradable (Orthopaedic fixation plate, non-biodegradable, Class IIb, sponsor KLS Martin). ARTG…

Intended purpose

An orthopaedic device, manufactured from a non-bioabsorbable material and in a non-customised process, that is implantable and intended to stabilise a fractured bone (excluding craniofacial and spinal). The device/ plate is used to treat either traumatic or pathological fractures, to fuse a joint (arthrodesis) and /or as part of an osteotomy. This device will be attached to a bone, typically but not limited to a bone of a limb, rib, sternum or pelvis. The plate is designed to be fixed in place with screws and maybe used in conjunction with another fixation device

TGA Public Summary