Device Dossier

PROCOTYL® L Acetabular Cup with Bead and Hydroxyapatite Coating - Metallic acetabulum prosthesis

Device Dossier for PROCOTYL® L Acetabular Cup with Bead and Hydroxyapatite Coating - Metallic acetabulum prosthesis (Metallic acetabulum prosthesis,…

Intended purpose

A total hip system component intended to replace the acetabulum. 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

The PROCOTYL® L acetabular cup is a hemispherical press-fit cup available in 14 sizes ranging from 42mm to 68mm (outer diameter; with 2mm increments between sizes) made from titanium alloy. An irregularly layered porous titanium bead and hydroxyapatite coating enhances initial fixation and long term bone apposition. The cup contains three screw holes located in one quadrant of the cup in additional to the apical hole to allow for surgical flexibility. For a screwless option, hole plugs, includin

TGA Public Summary