Increased FDA Scrutiny Limits Adoption of New Hip and Knee Technologies

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Since the high profile lawsuits for some metal-on-metal bearings, public outcry has prompted the FDA to heavily scrutinize new implant technology, reports iData Research.

Concerns about squeaking of noises and the increased rate of implant fractures will limit some ceramic/ceramic bearings market growth.

According to a new report by iData Research (, the leading global authority in medical device market research, the U.S. Market for Large Bone and Joint Orthopedic Devices is expected to grow to approximately $2 billion by 2020. Growth is driven by the increased number of younger joint replacement patients in the last two decades who will now be receiving hip and knee revision surgeries as their implants begin to fail. Hip and knee implants are segmented according to the bearing material such as metal- on -metal (MoM), ceramic- on -ceramic (CoC), ceramic- on -polyethylene (CoP), ceramic- on -metal and metal-on-polyethylene (MoP).

“Since the high profile failure of some MoM bearings, newer introductions have been heavily scrutinized in the medical and political industry,” explains Dr. Kamran Zamanian, CEO of iData. This prompted the FDA to initiate a study to examine the efficacy and safety of five new and widely used implants used in major joint reconstruction surgeries. Research team led by Art Sedrakyan, Associate Professor at Weill Cornell Medical College in New York concluded no convincing evidence supporting the use of the newer devices. Furthermore, higher revision rates have been reported with three of the newer devices, used in both hip and knee replacement surgery.

The above study determined that CoC did not improve functionality and had a higher revision rate, compared to older versions such as MoP and CoP. Although the increase in younger patients has driven the market for longer-wearing CoC bearings, concerns about squeaking noises and the increased rate of implant fractures will limit market growth. In contrast, the MoP and the CoP markets have represented the majority share of the hip and knee reconstruction market and are expected to experience growth through to 2020.

For Further Information
The global series on the “Markets for Large Bone and Joint Orthopedic Devices” cover 20 countries including the U.S., Japan, India, China, Brazil and 15 countries in Europe. The full reports provide a comprehensive analysis including procedure numbers, units sold, market value, forecasts, as well as a detailed competitive market shares and analysis of major players’ success strategies in each market and segment. The reports also cover markets for: knee reconstruction, hip reconstruction and bone cement.

Receive a free synopsis of the U.S. Market for Large Bone and Joint Orthopedic Devices.

About iData Research
iData Research ( is an international market research and consulting group focused on providing market intelligence for medical device and pharmaceutical companies. iData covers research in: Diabetes Drugs, Diabetes Devices, Pharmaceuticals, Anesthesiology, Wound Management, Orthopedics, Cardiovascular, Dental, Endoscopy, Gynecology, and more.

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Caroline Lau
iData Research
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