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510(k) Data Aggregation
(111 days)
The Libertas® Hip Replacement System is intended for use in total hip arthroplasty. Total hip arthroplasty is intended to provide patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to fix and support the components.
Total hip replacement is indicated for the following conditions:
- Non-inflammatory degenerative joint diseases including osteoarthritis, post traumatic arthritis and avascular necrosis.
- Rheumatoid arthritis.
- Congenital hip dysplasia.
- Acute traumatic fracture of the femoral head or neck.
- Certain cases of Ankylosis.
- Dislocation of the hip.
- Correction of functional deformity.
- Revision of failed joint reconstruction or treatment.
- Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur.
Note:
- The Modular Shell and Uncemented Stem are intended for press-fit, uncemented use only.
- The Cemented stem is intended for cemented use only.
The Libertas® - Taper Short Uncemented Femoral Stem (the subject device) is a line extension of the Libertas Hip System comprising of hip stem components for uncemented use in total hip arthroplasty. The subject device components are forged out of Ti-6Al-4V compliant with ASTM F136 Standard Specification for Wrought Titanium- 6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. The subject device adds non-collared and collared hip stem components to the product line, for a more proximally filling uncemented stem option compatible with all standard surgical approaches for total hip arthroplasty, including modern muscle-sparing techniques.
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