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FDA approves Novation for primary total hip arthroplasty with conditions
Exactech must perform a post-approval study evaluating long-term efficacy of the ceramic hip system.
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Exactech Inc's. Novation Ceramic Articulation Hip System received pre-market approval by the FDA for use in primary total hip arthroplasty in patients with non-inflammatory degenerative joint diseases.
The Novation is an alumina ceramic artificial hip replacement system that consists of a metal hip stem, a ceramic femoral head, a ceramic acetabular cup and a metal acetabular shell.
Indications for the device include patients with osteoarthritis, avascular necrosis, congenital hip dysplasia and traumatic arthritis.
According to details released with the FDA approval, Novation is not indicated for patients with the following: active or latent infection in or around the hip joint; acute or chronic systemic infections; skeletal immaturity; neurological or muscular conditions that could result in instability or overloading of the hip joint; poor skin coverage around hip joint; inadequate bone stock to allow proper insertion and fixation; metabolic bone disease and osteoporosis; known allergies to the implant materials; and/or a Body Mass Index (BMI) greater than 35.
Under the approval conditions, Exactech will perform a 10-year post-approval study evaluating the long-term safety and effectiveness of the Novation System. That study is to include a minimum of 250 patients, 175 of whom will be followed out to 5 years,
and 100 to 10 years. The FDA requires that the company collect for information for the study on Harris Hip Score, adverse events, radiographic and self-assessment data for each patient.
The results of the long-term study will be reflected in the product labeling once completed.
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