Device Dossier

H-Max M - Coated femoral stem prosthesis, modular

Device Dossier for H-Max M - Coated femoral stem prosthesis, modular (Coated femoral stem prosthesis, modular, Class III, sponsor Enovis Surgical). ARTG…

Intended purpose

The H Max M is a sterile implant designed to replace part of a partial or total hip Arthroplasty (THA)and is intended to reduce pain and give articular mobility to the patient. The H Max M is composed of two or more separate segments designed to be joined, and is coated with a hydroxyapatite intended to improve fixation and stability by promoting bone ingrowth.

Functional description

H Max M is a Modular stem made of forged and heat treaded (Ti6Al4V) titanium alloy and is coupled with a CoCrMo modular neck. The external surface has a layer of HA applied along the whole surface with a macro-roughened surface to enhance the bone integration for fast and effective osteointegration.

TGA Public Summary