Device Dossier

UNITRAX Modular Endoprosthesis Head - Metallic femoral head prosthesis

Device Dossier for UNITRAX Modular Endoprosthesis Head - Metallic femoral head prosthesis (Metallic femoral head prosthesis, Class III, sponsor Stryker).…

Intended purpose

Intended to be used as a hemiarthroplasty for the following indications: femoral neck fractures, idiopathic avascular necrosis, and nonunions.

Functional description

A sterile endoprosthesis used to replace the Femoral Head. Designed for use with an adapter sleeve to fit on the trunnion of a Femoral Hip Stem, through the use of locking tapers, mallet blows cold weld the metal surfaces of the head, sleeve and trunnion. The resultant assembly functions in a similar fashion to a fixed head endoprosthesis.

TGA Public Summary