Device Dossier

Amplitude Titanium Modular Necks - Femoral head/stem prosthesis adaptor

Device Dossier for Amplitude Titanium Modular Necks - Femoral head/stem prosthesis adaptor (Femoral head/stem prosthesis adaptor, Class III, sponsor…

Intended purpose

A sterile implantable adaptor to connect a femoral head prosthesis to a femoral stem prosthesis. It is intended to be used as part of a total hip arthroplasty (THA) revision to correct offset, neck length, lateralization, and anteversion/retroversion where there is a good fitting stem; it may also be used as part of a primary procedure.

Functional description

A titanium, sterile implantable tubular device designed to connect a femoral head prosthesis to the trunnion of a femoral stem prosthesis. It is used as part of a total hip arthroplasty (THA) revision to correct offset, neck length, lateralization, and anteversion/retroversion where there is a good fitting stem; it may also be used as part of a primary procedure. It is intended to be used with a dedicated femoral head prosthesis.

TGA Public Summary