FDA Approves First Ceramic-On-Metal Total Hip Replacement (press release)
The FDA approved the first ceramic-on-metal total artificial hip system for osteoarthritis patients, a device made by Johnson & Johnson’s (JNJ) DePuy Orthopaedics unit, the agency said Tuesday.
The move gives orthopedic surgeons and patients an additional option when considering total hip replacement surgeries, in which worn and damaged portions of bone and cartilage are removed and replaced with an artificial joint. Existing hip replacement systems use different combinations of metal, ceramic and a form of plastic called polyethylene.
The newly approved system is the first to combine a ceramic ball and a metal socket. As a condition of the approval, DePuy will conduct a postmarket study, monitoring patients for adverse events and metal ion concentrations in their blood, the FDA said.
In April, J&J reported its Depuy business saw U.S. hip and knee sales decline 6% from a year earlier in the first quarter, though officials noted hip and knee sales also improved from the fourth quarter. Meanwhile, a recall of hip-replacement parts weighed on company-wide results.
J&J shares closed Tuesday at $67.10. The stock has gained 15% the past year.
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