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Total MBK and unicompartmental MBK recommended for Class II
The panel recommended that special guidance documents be drafted for both devices.
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GAITHERSBURG, Md. — The Orthopaedic and Rehabilitation Devices Panel recently recommended that the FDA reclassify total mobile bearing knees and unicompartmental mobile bearing knees from Class III to Class II.
“It’s a win-win situation, and it’s going to make the general availability of these devices much more prominent,” said A. Seth Greenwald, DPhil (Oxon), Lutheran Hospital, Cleveland, Ohio. “It represents a further alternative to fixed-plateau knee designs,” he said.
The panel voted six to two in favor of the Orthopedic Surgical Manufacturers Association’s petition to reclassify the total mobile bearing knee (MBK) to Class II.
Safety and effectiveness
The panel recommended five special controls to reasonably assure the safety and effectiveness of the device, including a special controls guidance document.
Guidance documents do not yet exist for either device. Guidance documents inform manufacturers on what they are required to submit to the FDA with a 510(k) application. They also define what special controls the FDA needs to safely and effectively regulate these devices, according to Greenwald, who is a member of the Orthopedics Today editorial board on the Joint Reconstruction Section.
The panel recommended other controls, including testing guidelines, potential use of clinical data, device-specific training and labeling, and patient identification cards that would include patient, surgeon, hospital and implant information.
“It’s an idea whose time has come … and is going to open up the American market,” Greenwald said. “It will give DePuy Johnson & Johnson a huge opportunity to increase market share, as they are the de facto gold standard and other companies will attempt to sell against them. Their strength lies in the fact that they have 20-plus years of successful clinical experience.”
In addition, the panel voted five to three to recommend that the FDA reclassify the unicompartmental MBK into Class II.
According to the FDA, the panel recommended the same special controls as identified for the total MBK, with stronger emphasis on the use of clinical data. In addition, the panel also urged post-market surveillance to track such adverse events as osteolysis, bearing dislocations, polyethylene failures and revisions.