Device Dossier

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

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

Intended purpose

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 trauma or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. Hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or Girdlestone resection; fracture-dislocation of the hip; and correction of deformity. The REDAPT™ Revision Femoral Hip System is intended to be used without cement. The REDAPT Revision Hip System is indicated for revision surgery only.

Functional description

The REDAPT Sleeved Monolithic stem is a tapered, distally fixed femoral stem that is manufactured from forged titanium alloy (Ti-6Al-4V) and has a grit blast finish. The REDAPT Sleeved Monolithic stem features a non-modular, fixed neck; the stem utilizes modular sleeves, where the surgeon can elect to use a sleeved stem in cases where there is proximal/distal mismatch. It has a 12/14 neck taper design.

TGA Public Summary