Device Dossier
HYPE SC cementless stem - Press-fit femoral stem prosthesis
Device Dossier for HYPE SC cementless stem - Press-fit femoral stem prosthesis (Press-fit femoral stem prosthesis, Class III, sponsor Compliance…
- GMDN category: Press-fit femoral stem prosthesis
Intended purpose
Hype® SC cementless hip stems are designed to be implanted in the context of a first-line total hip replacement in order to relieve pain and restore the mobility of the hip. Indications are: – primary or secondary osteoarthritis, – avascular necrosis, – femoral neck fracture, – dysplasia, for skeletally mature adults (usually aged 65 and over), suffering from extreme pain and/or a disabled joint caused by a medical condition that was diagnosed at an earlier time and insufficiently improved by a correctly carried out medical treatment, after an observation period lasting from a few weeks to a few months.
Functional description
HYPE cementless stems are designed to be implanted with a femoral head and an acetabular cup system to replace the natural articulation of the hip. The stem is fixed to the femur. The stem is made of TA6V titanium alloy and available in several length, offset and version (collared/collarless). Primary fixation is achieved by pressfit while hydroxyapatite and porous titanium coating acts as a secondary fixation (bone growth directly onto the implant surface).