Device Dossier

PROFEMUR® CoCr Modular Necks - Femoral head/stem prosthesis adaptor

Device Dossier for PROFEMUR® CoCr Modular Necks - Femoral head/stem prosthesis adaptor (Femoral head/stem prosthesis adaptor, Class III, sponsor…

Intended purpose

A total hip system component intended to replace the anatomic femoral neck by mating with the prosthetic femoral head and modular femoral stem components. 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; 3) revision procedures where other treatments or devices have failed.

Functional description

CoCr modular necks mate in assembly with the appropriate modular femoral stem and femoral head. The modular necks are available in 11 sizes, offering 2 lengths and 6 angles. When combines with five possible femoral head bore sizes, these 11 neck options allow for 100 positions of possible head center location for a single modular stem and a single head diameter.

TGA Public Summary