Device Dossier

Orthopaedic prosthesis implantation instrument, reusable

Device Dossier for Orthopaedic prosthesis implantation instrument, reusable (Orthopaedic prosthesis implantation instrument, reusable, Class IIa, sponsor…

Intended purpose

Surgical instrument intended for use during hip, knee, shoulder, elbow or wrist arthroplasty, or trauma surgeries, to evaluate the patient’s joint surface anatomy following bone preparation and facilitate the physician’s determination of approximate implant size for the corresponding total joint replacement component. Several trial components may also be used concurrently to ensure proper joint ligamentous balance and range of motion prior to device implantation.

TGA Public Summary