Device Dossier

PROFEMUR® GLADIATOR® Plasma Classic Hip Stem - Press-fit hip femur prosthesis, one-piece

Device Dossier for PROFEMUR® GLADIATOR® Plasma Classic Hip Stem - Press-fit hip femur prosthesis, one-piece (Press-fit hip femur prosthesis, one-piece,…

Intended purpose

A total hip system component intended to replace the proximal femur. Indications include use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following condition: 1) non-inflammatory degenerative joint disease such as osteoarthritis.

Functional description

A titanium alloy cementless femoral stem with standard and extended neck options. The stem is coated with plasma spray and includes a driving platform, lateral shoulder, reduced tip and macrofeatures that provide additional rotational stability and maximise compressive loading forces.

TGA Public Summary