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The Indications for the Furloug® H-AC Total Hip Replacement System are:

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• Rheumatoid arthritis .
• Correction off functional deformity .
• Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
• Revision procedures where other treatments or devices have failed. .

Not Found

There is no information in the provided document about the acceptance criteria, device performance, or any studies conducted on the Furlong® H-AC Total Hip Replacement System. The document is an FDA 510(k) clearance letter, which indicates that the device has been found substantially equivalent to a predicate device and can be marketed. It lists the indications for use but does not contain details about specific performance metrics or studies.

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