Search Results

The Libertas™ Acetabular Hooded Liner is intended for use in total hip arthroplasty, in conjunction with the Libertas™ Hip Replacement System. 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 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.

Not Found

This FDA letter for K183365, "Libertas™ Acetabular Hooded Liner," does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The provided text is a 510(k) clearance letter confirming that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It discusses regulatory matters, product codes, indications for use, and general controls, but does not delve into the technical performance of the device or how its safety and effectiveness were demonstrated through specific tests or studies.

Therefore, I cannot fulfill your request to describe acceptance criteria and associated studies based on the provided input. This type of information would typically be found in the more detailed 510(k) submission document itself, which is not included here.

Ask a specific question about this device