ENGLISH
INSTRUCTIONS FOR USE
See product
label for method
ENGLISH
See product
label for method
CAUTION: Federal Law (USA) restricts this device to sale by or on the order of a physician.
DEVICE DESCRIPTION – TOTAL HIP PROSTHESIS
A Total Hip Prosthesis is composed of individually packaged titanium (Ti-6Al-4V) femoral hip
stem, modular metal or ceramic femoral head, and 2 piece metal-backed Ultra High Molecular
Weight Polyethylene (UHMWPE), ceramic*, or all UHMWPE acetabular components designed to
replace the natural articular surface of the hip joint.
*CAUTION: Devices used in ceramic-on-ceramic applications have additional full
prescribing information that must be reviewed prior to use.
INTENDED USE – TOTAL HIP PROSTHESIS
Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by
replacing the damaged hip joint articulation in patients where there is evidence of sufficient
sound bone to seat and support the components.
INDICATIONS – TOTAL HIP PROSTHESIS
Total hip replacement is indicated in the following conditions:
1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid
arthritis, or congenital hip dysplasia.
2. Avascular necrosis of the femoral head.
3. Acute traumatic fracture of the femoral head or neck.
4. Certain cases of ankylosis.
The ACTIS™ DUOFIX™ Hip Prosthesis is indicated for cementless use only.
DEVICE DESCRIPTION – HEMI-HIP PROSTHESIS
A Hemi-Hip Prosthesis is comprised of a titanium (Ti-6Al-4V) femoral stem and metal head
designed to replace the natural femoral head and neck in hemi-arthroplasty.
INTENDED USE – HEMI-HIP PROSTHESIS
Hemi-Hip Prostheses are intended to be used for hemi-hip arthroplasty where there is evidence
of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral
stem.
INDICATIONS – HEMI-HIP PROSTHESIS
Hemi-hip arthroplasty is indicated in the following conditions:
1. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated
with internal fixation.
2. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal
fixation.
3. Avascular necrosis of the femoral head.
4. Non-union of femoral neck fractures.
5. Certain high subcapital and femoral neck fractures in the elderly.
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