Device Dossier

PROFEMUR® XM Hip Stems - Uncoated femoral stem prosthesis, modular

Device Dossier for PROFEMUR® XM Hip Stems - Uncoated femoral stem prosthesis, modular (Uncoated femoral stem prosthesis, modular, Class III, sponsor…

Intended purpose

A total hip system component intended to repair or 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 conditions: 1) non-inflammatory degenerative joint disease such as osteoarthritis; 2) femoral neck fracture.

Functional description

The PROFEMUR® Xm stem is a dual-taper femoral stem made of highly polished forged CoCr for cemented use. Stems are available in sizes 0-4. Included with the femoral stem is a PMMA distal femoral stem centralizer, which is used to ensure the stem taper properly engages the cement mantle.

TGA Public Summary