Device Dossier

REDAPT Sleeveless Monolithic Revision Stem - Press-fit femoral stem prosthesis

Device Dossier for REDAPT Sleeveless Monolithic Revision Stem - Press-fit femoral stem prosthesis (Press-fit femoral stem prosthesis, Class III, sponsor…

Intended purpose

The REDAPT Sleeveless Monolithic Revision Stem is a femoral stem component of the REDAPT Revision Femoral System intended for use in revision hip surgery. It is intended to be used without cement. Indications for Use Hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of degenerative joint disease or any of its composite diagnoses of osteoarthritis, avascular necrosis, and traumatic arthritis. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, congenital dysplasia, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques, and fracture-dislocation of the hip

Functional description

The REDAPT Sleeveless Monolithic Revision Stem is a tapered, forged titanium (Ti-6Al-4V) stem with ROCKTITE distal flutes for improved diaphyseal fixation in all bone types and having a 12/14 taper head and a circulotrapezoidal neck for increased range of motion. It is used without cement.

TGA Public Summary